The DOI matches its Crossref record; 72 of the 72 references it cites were found in a registry or an index; 4 of the 31 sources its claims cite were checked for support.
Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient.
Open accessAbstract
We report the 1-year results from one patient as the preliminary analysis of a first-in-human phase I clinical trial (ChiCTR2300072200) assessing the feasibility of autologous transplantation of chemically induced pluripotent stem-cell-derived islets (CiPSC islets) beneath the abdominal anterior rectus sheath for type 1 diabetes treatment. The patient achieved sustained insulin independence starting 75 days post-transplantation. The patient's time-in-target glycemic range increased from a baseline value of 43.18% to 96.21% by month 4 post-transplantation, accompanied by a decrease in glycated hemoglobin, an indicator of long-term systemic glucose levels at a non-diabetic level. Thereafter, the patient presented a state of stable glycemic control, with time-in-target glycemic range at >98% and glycated hemoglobin at around 5%. At 1 year, the clinical data met all study endpoints with no indication of transplant-related abnormalities. Promising results from this patient suggest that further clinical studies assessing CiPSC-islet transplantation in type 1 diabetes are warranted.
Overview
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Written from the paper’s full text.
TL;DR
In a first-in-human phase I trial (ChiCTR2300072200), a 25-year-old woman with 11-year type 1 diabetes received an autologous transplant of chemically induced pluripotent stem-cell-derived islets (CiPSC islets) beneath the abdominal anterior rectus sheath and achieved sustained insulin independence from day 75 post-transplantation. At 1 year, all study endpoints were met with no transplant-related abnormalities detected.
Key findings
- The patient achieved complete insulin independence on day 75 and remained insulin-independent through 1 year of follow-up; daily exogenous insulin had been 54 ± 0.9 units/day at baseline.
- Time-in-target glycemic range rose from a baseline of 43.18% to 87.18% at month 2 and 96.21% at month 4, and was >98% for 8 months by the 1-year endpoint; HbA1c fell from 7.57% at baseline to 6.50% at day 75 and 5.37% at day 120, remaining in the non-diabetic range (<5.7%) thereafter.
- Graft function: fasting C-peptide was undetectable at baseline, rose to 59.6–102.6 pmol/L by week 2, and plateaued at 407.1–721.6 pmol/L after insulin independence; BETA-2 score increased from 0.13 at baseline to 21.42 at day 75 and 41.83 at day 365. OGTT peak C-peptide was 1,847.0, 1,439.9, and 2,472.6 pmol/L at days 180, 270, and 365 (3.5-, 2.8-, and 3.4-fold over fasting).
- Safety: no treatment-emergent serious adverse events; treatment-emergent AEs were limited to the peri-transplantation period (puncture-site pain, nausea/vomiting from general anesthesia); no severe hypoglycemic events during follow-up; MRI (T2W-FS and T1W-FS) and tumor markers (β-HCG, AFP, CEA, CA125, CA15-3, CA19-9) showed no evidence of teratoma over 1 year.
Methods
- First patient of an ongoing first-in-human phase I trial (TJFCH-iPS-001; ChiCTR2300072200) evaluating safety, tolerability, and efficacy of autologous CiPSC islets in type 1 diabetes; primary endpoints were HbA1c <7.0% or a ≥1% decrease from baseline at 90–365 days, absence of severe hypoglycemic events, and safety/tolerability; secondary endpoints included insulin independence and stimulated C-peptide ≥0.3 ng/mL.
- Autologous CiPSCs were generated from the patient's adipose-derived mesenchymal stromal cells by a four-step small-molecule chemical reprogramming protocol (clone CiPSC-#8 selected from 23 colonies), then differentiated via a six-stage protocol into islet-like cells; release testing included dd-PCR for residual PSCs, WGS/WES, viability (98%), CHGA positivity (94.5%), and a glucose stimulation index of 1.37.
- 1,488,283 IEQ (19,843 IEQ/kg) were injected under ultrasound guidance into the abdominal anterior rectus sheath on June 25, 2023, across 7 injections; the patient continued existing immunosuppression (tacrolimus, mycophenolate mofetil, methylprednisolone) with basiliximab and etanercept induction. Outcomes were tracked by continuous glucose monitoring, HbA1c, C-peptide, OGTT, BETA-2 score, ultrasound/MRI, tumor markers, and autoantibodies.
Limitations
- Stated by the paper: safety and efficacy beyond 1 year and in more patients remain to be evaluated; the trial includes three patients total, and data from the second and third patients were not yet mature for reporting, so a larger cohort is warranted.
- Stated by the paper: the patient's pre-existing immunosuppression for a transplanted liver precluded evaluation of the recipient's immune response to the autologous graft, limiting insight into potential autoimmune response.
- Evident from the text: this is a single-patient report, so no control group or between-patient comparison is possible, and the concurrent immunosuppressive regimen (including basiliximab and etanercept induction) cannot be separated from the graft's contribution to the observed outcomes.
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Claims the paper makes
78 Own result · 33 Own method · 20 Own interpretation · 9 Sources not found · 9 No basis given · 8 No full text of the sources · 4 Not checked yet · 3 Supported · 1 Supported so far
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Recently, we successfully reprogrammed human somatic cells to chemically induced PSCs (CiPSCs).”
What the sources say
- Not checked — no full text of the sourcecites [4] 4. Guan, J. ∙ Wang, G. ∙ Wang, J. ... Chemical reprogramming of human somatic cells to pluripotent stem cells Nature. 2022; 605:325-331 Crossref Scopus (178) PubMed Google Scholar source
- Supportedcites [5] 5. Liuyang, S. ∙ Wang, G. ∙ Wang, Y. ... Highly efficient and rapid generation of human pluripotent stem cells by chemical reprogramming Cell Stem Cell. 2023; 30:450-459.e9 Full Text Full Text (PDF) Scopus (44) PubMed Google Scholar source
The Results report generating hCiPSCs from human somatic cells obtained from all 17 tested donors. The Results also describe tests confirming that the resulting cells meet the criteria for pluripotent stem cells. (LLM, conf=0.94)
plaindirect- Asserted: passes — The authors put it forward as true.
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In the paper
“Thereafter, the patient presented a state of stable glycemic control, with time-in-target glycemic range at >98% and glycated hemoglobin at around 5%.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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In the paper
“Among them, 50 mice transplanted with the patient’s CiPSC-islets underwent histopathological analysis of major organs (heart, liver, spleen, kidney, lung, and brain) at the end of the observation period (Figure S2D), showing absence of graft-related malignancy even in high-dose transplantation experiments of up to 1 × 107 per mouse (Table S2).”
plainn = 50- Asserted: passes — The authors put it forward as true.
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In the paper
“Autologous CiPSCs were induced from adipose-derived mesenchymal stromal cells (ADSCs) isolated from the patient’s adipose tissue by chemical reprogramming as described previously.”
What the sources say
- Not checked — no full text of the sourcecites [4] 4. Guan, J. ∙ Wang, G. ∙ Wang, J. ... Chemical reprogramming of human somatic cells to pluripotent stem cells Nature. 2022; 605:325-331 Crossref Scopus (178) PubMed Google Scholar source
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“All safety and efficacy clinical endpoints were met at 1-year follow-up of the patient”
- Also stated in: § 1 Send email to zhongyangshen@vip.sina.com … Show more Show less · plain
“At 1 year, the clinical data met all study endpoints with no indication of transplant-related abnormalities.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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- Also stated in: § 1 Send email to zhongyangshen@vip.sina.com … Show more Show less · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At 1 year, the clinical data met all study endpoints with no indication of transplant-related abnormalities.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The CiPSC-islet preparation met release criteria for transplantation, presenting uniform spheroids between 50–250 μm and scarlet dithizone staining (Figures S3A and S3B), a high viability of 98% (Figure S3C; Table S1, part 3), and a Chromogranin A (CHGA)-positive proportion of 94.5% of total cells (Figures S3D and S3E), of which 56.4% were C-peptide and NKX6.1-positive cells.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Patient CiPSC-islets presented islet-sized aggregates containing approximately 60% β cells, 10% α-like cells, and 10% δ-like cells on average (Figures S1A–S1C).”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Prior to enrollment, the patient’s plasma C-peptide levels were below the limit of detection (6.6 pmol/L) under both fasting and glucose-challenged conditions.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Within 2 weeks after transplantation, the patient’s daily exogenous insulin dose requirement began to reduce from baseline of 54 ± 0.9 units/day (Figure 2A).”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
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- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
- Probably not a substantial claim. 51
- It may state two separate claims as one. 54
- The quote only partly states this claim. 2
Every source the paper cites for this claim was checked and supports it.
In the paper
“the generation of CiPSCs from somatic cells employs abiotic, small-molecule chemicals as reprogramming factors that are easily manufactured and standardized, non-genome integrating, scalable, and fine-tunable.”
What the sources say
- Supportedcites [6] 6. Wang, J. ∙ Sun, S. ∙ Deng, H. Chemical reprogramming for cell fate manipulation: Methods, applications, and perspectives Cell Stem Cell. 2023; 30:1130-1147 Full Text Full Text (PDF) Scopus (17) PubMed Google Scholar source
The Introduction (passage 6; page not provided) describes small-molecule reprogramming factors as abiotic, easily manufactured and standardized, and non-integrative to the genome. It also calls chemical reprogramming suitable for scalable stem-cell generation and describes the process as controllable and tunable (passage 4). (LLM, conf=0.94)
plain- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Different from conventional iPSCs, which are generated from somatic cells by genetic overexpression of transcription factors, the generation of CiPSCs from somatic cells employs abiotic, small-molecule chemicals as reprogramming factors”
What the sources say
- Supportedcites [6] 6. Wang, J. ∙ Sun, S. ∙ Deng, H. Chemical reprogramming for cell fate manipulation: Methods, applications, and perspectives Cell Stem Cell. 2023; 30:1130-1147 Full Text Full Text (PDF) Scopus (17) PubMed Google Scholar source
The Introduction describes conventional iPSC generation through forced expression of defined genes in somatic cells and contrasts TF-induced reprogramming with chemical reprogramming. It explicitly calls small molecules abiotic reprogramming factors and describes CiPSCs produced through chemical reprogramming. No page numbers are available in our copy. (LLM, conf=0.93)
plain- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“The small molecules used in the chemical reprogramming approach offer ease of manufacture and standardization and are highly controllable, scalable, and cost-effective, which are important for standardized manufacturing of therapeutic cells.6”
What the sources say
- Supportedcites [6] 6. Wang, J. ∙ Sun, S. ∙ Deng, H. Chemical reprogramming for cell fate manipulation: Methods, applications, and perspectives Cell Stem Cell. 2023; 30:1130-1147 Full Text Full Text (PDF) Scopus (17) PubMed Google Scholar source
Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plain- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The CiPSC-islets were found to be glucose-responsive in vitro, with a glucose stimulation index of 1.37 (Table S1, part 3).”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At the 1-year endpoint, the patient’s TIR had been >98% for 8 months, a substantial improvement in comparison with the baseline TIR of 43.18% (Figure 2C).”
- Also stated in: § Discussion · plain
“ultimately achieving over 98% blood glucose TIR without exogenous insulin use”
plaincorrelationalSingle case- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
- Also stated in: § Discussion · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The transplanted mice also showed restoration of glucose tolerance and glucose-responsive C-peptide secretion (Figures S2G and S2H).”
plaindirect- Asserted: passes — The authors put it forward as true.
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In the paper
“The pancreas graft was removed after a year due to severe thrombotic complications”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Her HbA1c level during the 2 years before enrollment was 7.40%–8.00%, higher than the American Diabetes Association (ADA)’s recommended target for T1D management (<7.0%).”
What the sources say
- Not matchedcites [29] 29. American Diabetes Association Professional, Practice Committee
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plainSingle case- Asserted: passes — The authors put it forward as true.
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- Not matched
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“and a Chromogranin A (CHGA)-positive proportion of 94.5% of total cells (Figures S3D and S3E), of which 56.4% were C-peptide and NKX6.1-positive cells.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The CiPSC-islet preparation also contained 13.4% glucagon-positive cells and 15.9% somatostatin-positive cells, as determined by flow cytometry and immunofluorescence staining (Figures S3D–S3J).”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These transplantation experiments showed good survival of patient CiPSC-islets and an absence of teratoma formation or graft overgrowth (Figures S2A and S2B), including mice observed for an extended period of up to 58 weeks;”
plainn = 244- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A 25-year-old woman was diagnosed with T1D for 11 years (as of time of transplantation in 2023).”
plainSingle case- Asserted: passes — The authors put it forward as true.
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In the paper
“Her medical history included two liver transplantations due to cryptogenic cirrhosis in 2014 and 2016, respectively, and a whole pancreas transplantation in 2017 due to unstable glycemic control.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Continuous glucose monitoring (CGM) measurements during the three months before transplantation showed severe glucose variability and endangerment by hypoglycemia”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Prior to the clinical study, the patient CiPSC-islets were assessed in 244 immunodeficient mice in transplantation experiments, with no tumorigenesis observed in all transplanted mice (Table S2).”
plainn = 244- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After insulin independence, the fasting C-peptide reached a plateau and fluctuated within a range of 407.1 to 721.6 pmol/L.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Her weight was 75 kg, and her body mass index was 27.3 kg/m2.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Based on assessments of panel reactive antibodies (PRAs), the patient was found to be PRA-positive for HLA-I and HLA-II antigens”
plainSingle case- Asserted: passes — The authors put it forward as true.
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In the paper
“The patient was under regular immunosuppression for liver transplant maintenance.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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In the paper
“Despite receiving intensive insulin treatment at a daily dose of 54 ± 0.9 units (mean ± SD) under the supervision of an endocrinologist, the patient was still not able to achieve target glycemic control.”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After CiPSC-islet transplantation, the patient’s fasting serum C-peptide level, which was undetectable at baseline, increased promptly and reached levels ranging 59.6–102.6 pmol/L by the second week after transplantation (Figure 3A).”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This was consistent with single-cell RNA sequencing (scRNA-seq) analysis of the patient CiPSC-islets, which also showed ∼13% endocrine progenitor cells and ∼8% enterochromaffin-like cells (Figures S1D–S1F)”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“accompanied by a decrease in glycated hemoglobin, an indicator of long-term systemic glucose levels at a non-diabetic level.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Her fasting glucose fluctuated greatly, with an average value of 210 ± 59 mg/dL (mean ± SD).”
plainSingle case- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A TIR of 87.18% was achieved in the patient at month 2 post-transplantation, which increased to 96.21% at month 4 (Figure 2C).”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The data showed that both transcripts were detected in CiPSC-islets at levels lower than the positive control and similar to the negative control, indicating that residual CiPSCs were not detected.”
hedgedSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In this patient, the transplantation area exhibited signal intensities comparable to the surrounding normal muscle tissue (iso-signal), indicating absence of abnormal fat accumulation (Figures 4I–4P).”
hedgedSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Before transplantation, the patient suffered from long-term, hard-to-control diabetes complicated by episodes of severe hypoglycemia.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“The blood glucose measurement at the 2 h time point was 155 mg/dL, which is below the diagnostic threshold for diabetes (≥200 mg/dL at 2 h).38”
What the sources say
- Not matchedcites [38]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
- Not matched
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“OGTT tests on days 180, 270, and 365 visits showed peak C-peptide levels of 1,847.0, 1,439.9, and 2,472.6 pmol/L, respectively, while the fold change in peak C-peptide values relative to the fasting C-peptide values was 3.5, 2.8, and 3.4, respectively (Figure 3D).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The parallel C-peptide levels were 589.2 pmol/L in the fasting state and peaked at 2 h after glucose administration at 1,436.5 pmol/L, showing a 2.4-fold stimulation (Figure 3D).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one. The quote only partly states this claim.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“To improve glycemic control, the patient had previously received a pancreas transplantation in 2017, which had to be removed a year later due to thrombotic complications.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A slight elevation in glutamic acid decarboxylase antibody (GADA) level at one time point was observed.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Karyotype screen of the 23 clones with good morphology and normal cell growth showed abnormal karyotype in one, #11, which was removed from downstream screening.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In this study, good-manufacturing-practice-compliant manufacture of personalized CiPSC-islets for autologous transplantation was conducted, allowing for the first report of clinical transplantation of CiPSC-derived cells.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Throughout follow-up, the patient was hospitalized one time for an upper respiratory tract infection and was discharged 5 days later.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The patient’s BETA-2 score increased steadily from a baseline value of 0.13 to 21.42 by the day 75 visit, with the most recent value of 41.83 at day 365 visit (Figure 3E)”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Insulin autoantibody (IAA), islet cell antibody (ICA), insulinoma-associated-2 antibodies (IA-2Ab), and zinc transporter 8 antibody (ZnT8) were consistently indicated as negative.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“In addition, a whole pancreas transplantation was performed on May 4th, 2017, but the pancreas graft was removed one year later (August 8th, 2018) due to thrombotic complications.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“From the day 180 visit, the patient’s glucose tolerance showed further improvement, showing relatively stable performance in OGTTs of subsequent visits thereafter (Figures 3B and 3D).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The treatment-emergent AEs were limited to the peri-transplantation period, which included pain at the puncture area and nausea and vomiting due to general anesthesia.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Before CiPSC-islets transplantation, the patient had undergone two liver transplants on July 8th, 2014 and September 27th, 2016, for liver cryptogenic cirrhosis.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“and the one with the highest cell yield was chosen for downstream manufacture (patient CiPSC-#8).”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At the day 120 visit, the meal-responsiveness of C-peptide secretions was further improved, with a fasting level of 407.1 pmol/L and a 2-h postprandial level of 834.1 pmol/L.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In this report, we present data from the clinical trial's first participant—a 25-year-old female with an 11-year history of T1D.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Subsequent T2W-FS images taken over the following 365 days after transplantation showed that the signal of the grafts remained consistent and stable in terms of location, shape, size, and magnetic resonance signal intensity, and the left abdominal rectus exhibited no signs of compression, displacement, or deformation, which together showed no indication of abnormal growth (Figures 4D–4H).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The average temperature was -196.2°C, with highest temperature at -190.7°C and lowest temperature at -196.4°C respectively.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“We found that transplantation to an extrahepatic site, underneath the abdominal anterior rectus sheath, led to superior CiPSC-islet survival and maturation, resulting in secretion levels of C-peptide (a marker of endogenous insulin secretion) and stimulation indices approaching those of non-diabetic humans.”
What the sources say
- Not checked — no full text of the sourcecites [21] 21. Liang, Z. ∙ Sun, D. ∙ Lu, S. ... Implantation underneath the abdominal anterior rectus sheath enables effective and functional engraftment of stem-cell-derived islets Nat. Metab. 2023; 5:29-40 Crossref Scopus (24) PubMed Google Scholar source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“we established a highly efficient, optimized differentiation protocol for the generation of islet-like cells from CiPSCs (CiPSC-islets), whose transcriptomic identity, composition, and insulin secretory function were comparable to that of native human islets.”
What the sources say
- Not checked yetcites [20] 20. Du, Y. ∙ Liang, Z. ∙ Wang, S. ... Human pluripotent stem-cell-derived islets ameliorate diabetes in non-human primates Nat. Med. 2022; 28:272-282 Crossref Scopus (85) PubMed Google Scholar
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“with in-process quality control (QC) assessments throughout the manufacturing process.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This study was approved by the National Health Commission of the People’s Republic of China and the Medical Ethics Committee at Tianjin First Central Hospital.”
- Also stated in: § Author contributions · plain
“and was approved by the National Health Commission of the People’s Republic of China and the Medical Ethics Committee at Tianjin First Central Hospital”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Also stated in: § Author contributions · plain
None of the sources cited for this claim could be matched to a paper in Crossref, so there is nothing to check it against.
In the paper
“indicating an increased risk of rejection and graft failure in the case of islet allotransplantation.”
What the sources say
- Not matchedcites [31]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Not matchedcites [32]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Not matchedcites [33]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The patient CiPSC-islet manufacturing process was subject to in-process QCs as shown in Table S1, part 2.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Systematic characterization of the selected patient CiPSC line used for downstream manufacture (patient CiPSC-#8) was performed, including trilineage differentiation potential and genomic stability assays.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These findings supported the viability of CiPSC-islet transplantation underneath the abdominal anterior rectus sheath, which led to relatively rapid restoration of insulin-independent glycemic control in the patient.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“In vivo tumorigenicity tests prior to clinical transplantation of patient CiPSC-islets were performed on 50 immunodeficient SCID/Beige mice.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In this study, an extrahepatic site was employed, which was a favorable option for this patient on account of her transplanted liver.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Non-synonymous mutations identified were shown below. The pathogenicity and/or carcinogenicity of these mutations was evaluated by screening of each genomic variants against the COSMIC Census, and their status in COSMIC databases and Clinvar databases, if any, was annotated in the right two columns.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Viability and yield were verified by trypan blue (Invitrogen, T10282) and Countess II Automated Cell Counter (Invitrogen, AMQAX1000).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The BETA-2 score, which used fasting metabolic variables, was derived and validated by Peter Senior, Shareen Forbes, and colleagues from individuals transplanted in the Edmonton Islet Transplantation Program and is widely used in the clinical assessment of graft function after islet transplantation.”
What the sources say
- Not matchedcites [69]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Firstly, safety and efficacy beyond 1 year and in more patients remain to be evaluated.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
In the paper
“while each 1% reduction of HbA1c toward the physiological level has been associated with a 21% reduction in risk of diabetes-related complications and death.52”
What the sources say
- Not matchedcites [52]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Follow-up with these patients is ongoing, as they were sequentially enrolled in accordance with regulatory safety requirements.”
plaindirectn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“and was conducted in accordance to the Clinical Study Protocol (Data S1).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Whole-genome sequencing data and whole-exome sequencing data (WGS and WES) were generated for the patient’s ADSCs, CiPSC line, and the patient’s CiPSC-islets.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Flow cytometry was performed in dissociated cells for islet endocrine cell-related markers (NKX6.1, C-peptide, GCG, SST).”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“During this time before transplantation, the items in Quality control and final check of CiPSC-islets preparation before transplantation (as shown in Table S1 Part 3) were tested as a final check.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The current patient provided written informed consent to undergo the procedure.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Secondly, the use of immunosuppressants in this patient precluded the evaluation of immune response of the recipient to the autologous graft.”
- Also stated in: § Discussion · hedged
“but insight into potential autoimmune response was limited.”
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § Discussion · hedged
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“However, due to the limited follow-up period and according to our clinical trial protocol, data from these two patients are not yet matured for reporting.”
plainn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Taken together, these findings indicate the feasibility of chemically induced autologous PSCs for cell therapy, constituting a viable personalized medicine strategy.”
hedgedSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Glucose stimulated insulin secretion (GSIS) assay was conducted to evaluate the Glucose Stimulation Index (GSI) of functional potency.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
In the paper
“In comparison to intraportal transplantation, the abdominal rectus sheath site also encompasses other safety considerations, such as ease of access for transplantation and imaging and site retention of graft.21”
What the sources say
- Not checked — no full text of the sourcecites [21] 21. Liang, Z. ∙ Sun, D. ∙ Lu, S. ... Implantation underneath the abdominal anterior rectus sheath enables effective and functional engraftment of stem-cell-derived islets Nat. Metab. 2023; 5:29-40 Crossref Scopus (24) PubMed Google Scholar source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“For the CiPSC induction, a four step chemical reprogramming protocol without genetic manipulation was applied to patient ADSCs as described previously.4”
What the sources say
- Not checked — no full text of the sourcecites [4] 4. Guan, J. ∙ Wang, G. ∙ Wang, J. ... Chemical reprogramming of human somatic cells to pluripotent stem cells Nature. 2022; 605:325-331 Crossref Scopus (178) PubMed Google Scholar source
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“the viability of CiPSC-islets was tested by fluorescein diacetate (FDA) / propidium iodide (PI) staining.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“CiPSC-islet cell recovery and preparation was conducted at the clinical site under GMP-level conditions.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The trial is ongoing and includes three patients in total.”
plainn = 3- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“Data from another clinical trial (NCT04786262), which transplanted hPSC-derived islets into the hepatic portal vein, were recently announced, the findings of which also indicated positive outcomes post-transplantation.60”
What the sources say
- Not matchedcites [60]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Short tandem repeat (STR), whole genome sequencing (WGS) and whole exome sequencing (WES) tests were conducted on the selected clone #8, which passed all the tests.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Taken together with our preclinical studies, the clinical data in this report support the clinical value of this transplantation strategy, warranting continued exploration.”
plaincorrelationalSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The patient CiPSC-#8 cell line was assessed for quality according to the requirements in Table S1 Part 1.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study was conducted in accordance with the Declaration of Helsinki”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Thorough testing of the final CiPSC-islets was conducted to detect for residues of concern, including residual BSA and cytokines.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“C-peptide measures taken in parallel showed undetectable C-peptide levels (Figure 3D), indicating a complete destruction of β cells and poor glucose tolerance.”
hedgeddirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“In addition, mycoplasma contamination, sterility and endotoxin levels were checked according to protocols in the Chinese pharmacopoeia (2020 version).”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The reagents used in the entire manufacturing process was subject to reagent controls, including checking documentation of certificates of analysis (COA) of every reagent.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Prior to the start of patient recruitment, the trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300072200).”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“We performed droplet digital PCR (dd-PCR) to verify biosafety of patient CiPSCs-islets.”
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Taken together, these results indicated good graft function of the transplanted CiPSC-islets and recovery of endogenous, glucose-responsive insulin secretion in the patient.”
hedgeddirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All of the mouse experiments performed were approved by the Institutional Animal Care and Use Committee of Peking University.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper relies on this without support.
The extraperitoneal transplant site has minimal invasiveness of injection and ease of imaging.
“Other important advantages of this self-contained extraperitoneal transplant site include minimal invasiveness of injection at the site and ease of imaging.”
The paper relies on this without support.
The clinical improvements observed after transplantation are attributable to the transplanted CiPSC-islets rather than to other factors such as the immunosuppressive regimen, residual endogenous insulin secretion, or the natural history of the patient’s diabetes.
“After CiPSC-islet transplantation, the patient achieved insulin independence within 3 months post-transplantation, ultimately achieving over 98% blood glucose TIR without exogenous insulin use.”
The paper relies on this without support.
The absence of tumorigenicity observed in mice and nonhuman primates predicts the absence of tumorigenicity in the human patient.
“Prior to the clinical study, the patient CiPSC-islets were assessed in 244 immunodeficient mice in transplantation experiments, with no tumorigenesis observed in all transplanted mice (Table S2).”
The paper relies on this without support.
The patient’s immunosuppressive maintenance regimen did not confound the glycemic or graft-function outcomes attributed to the CiPSC-islet transplant.
“the immunosuppressive maintenance regimen included tacrolimus, mycophenolate mofetil, and methylprednisolone tablets, which were continued after CiPSC transplantation”
The paper relies on this without support.
The abdominal anterior rectus sheath site is safe and effective for stem-cell-derived islet transplantation in humans based on preclinical studies.
“The positive metabolic data seen in this clinical study are consistent with that seen in our preclinical study in nonhuman primates, in which we sought to identify an optimal transplant site for CiPSC-islets.21”
The paper relies on this without support.
Type 1 diabetes is an autoimmune disease.
“Because T1D is an autoimmune disease”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source says what the claim attributes to it.
In the citing paper
“These studies indicate that current technology can produce stemcell derived β cells capable of reversing type 1 diabetes (figure 2).”
From The future of type 1 diabetes therapy (2025) · cites this paper as [72]
The cited source says what the claim attributes to it.
In the citing paper
“In this study, the cells were transplanted into the rectus sheath in the anterior abdominal wall (table 3).72”
From The future of type 1 diabetes therapy (2025) · cites this paper as [72]
The cited source says what the claim attributes to it.
In the citing paper
“These induced pluripotent stem cells were generated by chemical reprogramming of the cells using small molecules to dedifferentiate the cells rather than genetic methods.”
From The future of type 1 diabetes therapy (2025) · cites this paper as [72]
The cited source says what the claim attributes to it.
In the citing paper
“Another landmark event in type 1 diabetes treatment was the reversal of diabetes with β cells derived from autologous induced pluripotent stem cells in a recipient with previous liver transplantation and therefore on immunosuppression.72”
From The future of type 1 diabetes therapy (2025) · cites this paper as [72]
The cited source says what the claim attributes to it.
In the citing paper
“Although stemcell therapy has shown remarkable results in a few people, 71,72 its promise as a therapy for broad application is dependent on the safe engineering of cells that avoid both alloimmunity and autoimmunity, and on production methods that meet the global demand for cellbased therapy at affordable costs.”
From The future of type 1 diabetes therapy (2025) · cites this paper as [72]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated major: it would touch a result — a value a result rests on, reported and recomputed p-values on opposite sides of the significance level, two passages that conflict with no sign which is right, or a cited work retracted before this paper was published.
In the paper
§ Author contributions
“On day 0, 40 cryopreserved vials of CiPSC-islet cells (1.8 × 108 cells per vial) were thawed in a 37 °C water bath.”
§ Author contributions
“cells were suspended at 3 × 107 cells/mL in cryopreservation medium (5% dimethylsulfoxide (DMSO) (Sigma-Aldrich, D2650), 60% stage 6 medium, 35% FBS and 10 μM Y27632). Then, a 4 mL cell suspension was aliquoted into 5 mL vials.”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Discussion
“this allowed the assessment of therapeutic capacity of CiPSC-islets without adding to the patient’s immunosuppression burden”
§ Author contributions
“For CiPSC-islets transplantation, Basiliximab (20 mg) was used for induction therapy on day 0 and day 4.”
Citations
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Comprehensive Integration of Single-Cell Data
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ANNOVAR: functional annotation of genetic variants from high-throughput sequencing data
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Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells
Yu, J., Vodyanik, M. A., Smuga-Otto, K., Antosiewicz-Bourget, J., Frane, J. L., Tian, S., Nie, J., Jonsdottir, G. A., Ruotti, V., Stewart, R., et al. (2007) · Science · doi:10.1126/science.1151526 · Cited by 10,310
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Production of pancreatic hormone–expressing endocrine cells from human embryonic stem cells
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Cited by
Sorted by citations
Pluripotent stem-cell-derived therapies in clinical trial: A 2025 update
Kirkeby, A., Main, H., & Carpenter, M. (2025) · Cell stem cell · doi:10.1016/j.stem.2024.12.005 · Cited by 233
Type 2 diabetes mellitus – conventional therapies and future perspectives in innovative treatment
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“This method offers an alternative means to generate human pluripotent stem cells (hPSCs) that may be more suitable for therapeutic applications [177].”
Progress and challenges in developing allogeneic cell therapies
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Advances in Cell Replacement Therapies for Diabetes
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“…trial (ChiCTR2300072200) reported autologous transplantation of chemically induced pluripotent stem cell-derived islets beneath the anterior abdominal wall in a patient with type 1 diabetes, achieving insulin independence by day 75 and maintaining glycemic control at one year after transplant 113 .”
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“Notably, our recent research showed that transplantation of hCiPS cell-derived islets into an individual with type 1 diabetes resulted in sustained insulin independence and restored glycemic control 27 .”
Self-citationThe future of type 1 diabetes therapy
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A wearable device for continuous immunoassay-based monitoring of C-peptide in interstitial fluid
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“Moreover, with the development of islet transplantation, gene therapy, and cell therapy, the cure of diabetes has gradually become possible ( 11 – 13 ).”
Self-citationChemical reprogramming ameliorates cellular hallmarks of aging and extends lifespan
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“…regeneration in the liver and heart, thus providing proof-of-principle that treatment with these reprogramming-associated chemicals could bene fi t tissue repair and, more recently, enable autologous islet replacement in type 1 diabetes (Tang and Cheng, 2017; Huang et al, 2018; Wang et al, 2024).”
Stem cell therapies for diabetes
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Human Organoids and Their Application in Tumor Models, Disease Modeling, and Tissue Engineering
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“rectus sheet in a patient with type 1 diabetes, and insulin independence was restored 75 days after transplantation 145 .”
InfluentialStem cells as role models for reprogramming and repair
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Emerging Immunotherapies for Disease Modification of Type 1 Diabetes
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Self-citationGlobal perspectives on monogenic forms of diabetes
Russ‐Silsby, J., Teles, M. G., Hassan, S. S., Elbarbary, N. S., Ngọc, C. T. B., & Franco, E. D. (2025) · Diabetologia · doi:10.1007/s00125-025-06495-3 · Cited by 23
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Chemical reprogramming of human blood cells to pluripotent stem cells
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Self-citationCell reprogramming: methods, mechanisms and applications
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“…al. 2022; Liuyang et al. 2023); the circumvention of immune responses via the utilization of autologous iPSC-derived cell products (Mandai et al. 2017; Sharma et al. 2019; Wang et al. 2024c) or HLA-matched iPSC-derived cell products (Sugita et al. 2016, 2020; Kawamura et al. 2016; Xu et al. 2019).”
InfluentialEvans‐Molina, C., Dor, Y., Lernmark, Å., Mathieu, C., Millman, J. R., Mirmira, R. G., Pociot, F., REDONDO, M. J., Rich, S. S., Richardson, S. J., et al. (2025) · Diabetes Care · doi:10.2337/dci25-0013 · Cited by 17
Advancements and Challenges in Immune Protection Strategies for Islet Transplantation
Wang, X., Zeng, Z., Li, D., Wang, K., Zhang, W., Yu, Y., & Wang, X. (2025) · Journal of Diabetes · doi:10.1111/1753-0407.70048 · Cited by 18
Self-citationThe Last Mile in Beta-Cell Replacement Therapy for Type 1 Diabetes: Time to Grow Up
Piemonti, L. (2025) · Transplant International · doi:10.3389/ti.2025.14565 · Cited by 16
Stem cell therapy for diabetes: Advances, prospects, and challenges
Zuo, D., Wang, C., Sang, M., Sun, X., Chen, G., & Ji, K. (2025) · World Journal of Diabetes · doi:10.4239/wjd.v16.i7.107344 · Cited by 18
Sundheim, B., Hirani, K., Blaschke, M., Lemos, J. R. N., & Mittal, R. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14020383 · Cited by 15
“A recent study transplanted chemically induced pluripotent stem cell-derived islets (CiPSCs) beneath the abdominal anterior rectus sheath in an adult T1D patient [153].”
Chemical-based epigenetic reprogramming to advance pluripotency and totipotency
Wen, S., Zheng, R., Cai, C., & Jiang, W. (2025) · Nature Chemical Biology · doi:10.1038/s41589-025-01874-8 · Cited by 14
“Particularly, autologous CiPSC-derived islet transplantation has shown promising therapeutic effects in one patient with type 1 diabetes during a 1-year clinical follow-up 85 .”
Stem-cell-derived beta cells mature metabolically upon murine engraftment
Vähäkangas, E., Saarimäki‐Vire, J., Montaser, H., Lithovius, V., Eurola, S., Ibrahim, H., Kuuluvainen, E., Balboa, D., Katajisto, P., Barsby, T., et al. (2025) · Diabetologia · doi:10.1007/s00125-025-06474-8 · Cited by 13
“This finding is important for ongoing clinical trials using SC-islet cells, as any retention of immature responsiveness to non-glucose fuels could cause dysregulated insulin secretion and hypoglycaemia [11, 12, 28–30].”
Toward a cure for diabetes: iPSC and ESC ‐derived islet cell transplantation trials
Fujikura, J., Anazawa, T., Toyoda, T., Ito, R., Kimura, Y., & Yabe, D. (2024) · Journal of Diabetes Investigation · doi:10.1111/jdi.14366 · Cited by 11
“8 , it is interesting from the perspective that it can be suf fi ciently effective even when transplanted to local site that directly access to systemic circulation, not portal circulation.”
Sali, S., Azzam, L., Jaro, T., Ali, A. A. G., Mardini, A., Al-Dajani, O., Khattak, S., Butler, A. E., Azeez, J. M., & Nandakumar, M. (2025) · Stem Cell Research & Therapy · doi:10.1186/s13287-025-04293-7 · Cited by 14
“A Phase I clinical trial (ChiCTR2300072200) has also shown success in treating T1D patients using autologous chemically induced pluripotent stem cell (CiPSC)-derived islet cells implanted beneath the abdominal anterior rectus sheath [152].”
Decoding human chemical reprogramming: mechanisms and principles
Cheng, L., Wang, Y., Guan, J., & Deng, H. (2025) · Trends in Biochemical Sciences · doi:10.1016/j.tibs.2025.03.004 · Cited by 11
Self-citationBottom-up Biomaterial strategies for creating tailored stem cells in regenerative medicine
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“This approach restored exogenous insulin-independent glycemic control, with the patient maintaining stable blood glucose levels and meeting all pre-de fi ned safety and ef fi cacy endpoints at the 1-year follow-up (Wang et al., 2024b).”
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“Stem cell–based therapies, though promising, are currently limited to phase I trials with small sample sizes, and their safety and reproducibility remain to be validated [325].”
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Innovative approaches to boost mesenchymal stem cells efficacy in myocardial infarction therapy
An, C., Zhao, Y., Guo, L., Zhang, Z., Yan, C., Zhang, S., Zhang, Y., Shao, F., Qi, Y., wang, X., et al. (2025) · Materials Today Bio · doi:10.1016/j.mtbio.2025.101476 · Cited by 11
Self-citationFrom bench to bedside: future prospects in stem cell therapy for diabetes
Lu, J.-Y., Cheng, H., Chen, K.-Y., & Zhang, F. (2025) · Journal of Translational Medicine · doi:10.1186/s12967-024-06019-4 · Cited by 9
The current state of Cytotherapy and the field of cell and gene therapy
Hwang, W. Y. K., & Muzammil, E. M. (2025) · Cytotherapy · doi:10.1016/j.jcyt.2025.01.017 · Cited by 10
Huan, Z., Li, J., Cao, X., Yu, Y., Yu, Y., & Li, L. (2025) · 中国科学通报：英文版 · doi:10.1016/j.scib.2025.06.016 · Cited by 10
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Stem cells reverse woman’s diabetes — a world first
Mallapaty, S. (2024) · Nature · doi:10.1038/d41586-024-03129-3 · Cited by 10
Bioprinting and synthetic biology approaches to engineer functional endocrine pancreatic constructs.
Ribezzi, D., Català, P., Pignatelli, C., Citro, A., & Levato, R. (2025) · Trends in Biotechnology · doi:10.1016/j.tibtech.2025.03.005 · Cited by 10
Glucose metabolism and regulation in establishing human stem cell-derived β cell maturation
Lin, H., Liu, X., Chen, L., Guo, Y., Xu, T., & Liu, H. (2025) · Cell Reports · doi:10.1016/j.celrep.2025.115892 · Cited by 10
Stem cell-derived pancreatic beta cells: a step closer to functional diabetes treatment?
Ogieuhi, I. J., Agbo, C. E., Ajekiigbe, V. O., Chidera Stanley Anthony, M., Onyehalu, J. C., Nwankwo, C. K., Agu, M. C., Lema, K. F., Adewole, O. A., Asade, O. O., et al. (2025) · BMC Endocrine Disorders · doi:10.1186/s12902-025-01997-y · Cited by 14
“Several trials reported significant reductions in insulin doses [62], with some patients even achieving insulin independence [63].”
A Cure for Type 1 Diabetes: Are We There Yet?
Schaaf, C., & Sussel, L. (2025) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2024.0498 · Cited by 10
“54 The patient had glycemic TIR of 96% 4 months after transplantation, and 75 days post-transplantation achieved insulin independence.”
Wan, J., Xu, Y., Qi, T., Xue, X., Li, Y., Huang, M., Guo, Y., Guo, Q., Lu, Y., & Huang, Y. H. (2025) · Journal of Nanobiotechnology · doi:10.1186/s12951-025-03266-5 · Cited by 8
The future of islet transplantation beyond the BLA approval: challenges and opportunities
Wang, Y., McGarrigle, J. J., Cook, J., Rios, P., Monica, G. L., Chen, Y., Wei, W., & Oberholzer, J. (2025) · Frontiers in Transplantation · doi:10.3389/frtra.2025.1522409 · Cited by 9
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Hypoimmune stem cells and islets: hype or a true breakthrough in diabetes treatment?
Shalaby, K. E., & Abdelalim, E. M. (2025) · Cellular & Molecular Biology Letters · doi:10.1186/s11658-025-00786-8 · Cited by 10
“Excitingly, a clinical trial is showing promising outcomes for this transplantation site [63].”
Zhang, K., Wang, Y., An, Q., Ji, H., Wu, D., Li, X., Suo, L., Zhang, C., & Dong, X. (2024) · Cell Proliferation · doi:10.1111/cpr.13785 · Cited by 9
“Recent studies have demonstrated the promise of hCiPSCs in clinical applications, further reinforcing the value of using autologous hCiP-SCs and their derivatives in future trails [42].”
Lineage tracing of pancreatic cells for mechanistic and therapeutic insights
Zhao, H., & Zhou, B. (2025) · Trends in Endocrinology and Metabolism · doi:10.1016/j.tem.2024.12.008 · Cited by 7
Hypoimmunogenic pluripotent stem cells: A game-changer in cell-based regenerative medicine
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Zinc Transporters in Diseases, Including Diabetes and Related Conditions
Xu, W., Wang, X., Gao, Y., Ma, Q., & Li, W. (2025) · Physiology · doi:10.1152/physiol.00026.2025 · Cited by 7
Self-citationThe role of endothelial cells in pancreatic islet development, transplantation and culture
Geng, A., Yuan, S., Yu, Q. C., & Zeng, Y. A. (2025) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2025.1558137 · Cited by 7
Advances in Regulatory Cell Therapy for Type 1 Diabetes: Emerging Strategies and Future Directions
Passerini, L., Forlani, A., & Gregori, S. (2025) · European Journal of Immunology · doi:10.1002/eji.202451722 · Cited by 11
“A long-lasting T1D patient transplanted with autologous iPSC-derived islets was recently reported to maintain normoglycemia after 1 year of follow-up [11].”
Medical embryology and regenerative medicine: research and applications in clinical practice
Soczyńska, J., Gawełczyk, W., Obrycka, P., Żołyniak, M., Muzyka, A., Majcherczyk, K., Papierkowska, J., & Woźniak, S. (2025) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2025.1619036 · Cited by 8
Advances in stem cell–derived beta-cell therapy: A new frontier in type 1 diabetes treatment
Upadhye, K. S., & Tayade, P. (2026) · Cell Transplantation · doi:10.1177/09636897261417623 · Cited by 8
“…oxygen-permeable biomaterials, VEGF-releasing scaffolds, and co-transplantation with MSCs, are being actively investigated to enhance local oxygenation, promote vascular integration, and improve graft survival, underscoring oxygen supply as a critical determinant of long-term clinical success 35 .”
Zhang, Y., Chen, X., Yao, Y., Huang, Z., Yang, Y., Yang, C., Zhu, Y., Qiu, Y., Wang, Q., Huang, D., et al. (2025) · Colloids and Surfaces B Biointerfaces · doi:10.1016/j.colsurfb.2025.115184 · Cited by 5
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“Early clinical trials have provided excitement regarding the therapeutic potential for SC-islet transplantation to provide a functional cure for T1D 3,96 .”
Glucose Metabolism Modulation as a Strategy to Enhance Cancer Radiotherapy
Gao, S., Liu, X., Chen, S., & Zhou, P. (2025) · Metabolites · doi:10.3390/metabo15120793 · Cited by 5
“This approach accelerates epigenetic reprogramming via the histone modifiers KAT3A/B and KAT6A, supporting personalized therapeutic applications [152].”
Hossain, M. K., & Kim, H.-R. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27031280 · Cited by 5
Immune modulation for β-cell replacement in type 1 diabetes
Yang, Q., Song, Y., Markmann, J. F., & Lei, J. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1785523 · Cited by 5
“However, their broader application remains constrained by drug-related toxicity, infection risk, and long-term immunologic complications associated with chronic immunosuppression (179 – 181).”
Clinical translational research on stem cell products: prospects and challenges
Chen, S., ZHANG, L., Ren, Y., Bai, X., Wei, X., Chai, M., 崔苏甦, Zhao, X., & Deng, H. (2026) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-026-02582-y · Cited by 17
“In 2024, a major break-through was made in clinical research using autologous iPSC-derived islet cells for the treatment of type 1 diabetes (T1DM) and type 2 diabetes (T2DM) 39,40 (Fig.”
Self-citationIslet organoids: a new hope for islet transplantation in diabetes
Yu, X.-Z., Liu, C.-K., Kuang, Z., Song, S.-Y., Tian, L., & Wang, Y. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1540209 · Cited by 8
Rewiring the seizing brain: stem cell grafts as neuromodulatory architects in epilepsy therapy
Wang, Z., Ma, Y., Hu, X., & Xia, Y. (2025) · Frontiers in Neurology · doi:10.3389/fneur.2025.1596484 · Cited by 5
Self-citationCell Therapy for T1D Beyond BLA: Gearing Up Toward Clinical Practice
Wang, Y., Chen, Y., McGarrigle, J. J., Cook, J., Rios, P., Monica, G. L., Wei, W., & Oberholzer, J. (2025) · Diabetes Therapy · doi:10.1007/s13300-025-01732-9 · Cited by 5
“On the basis of the chemically induced pluripotent stem cell (CiPSC) technology [40, 45–47], a recent study reported the 1-year outcomes of a patient with T1D who underwent autologous transplantation of chemically induced pluripotent stem cell-derived islets (CiPSC islets) beneath the abdominal…”
InfluentialStem cells therapies for liver diseases: for current practice and future goals
Xie, Y., Zhang, Z., Pan, Y., & Wang, F. (2025) · Hepatology International · doi:10.1007/s12072-025-10835-1 · Cited by 6
“Induced pluripotent stem cells (iPSCs), generated by reprogramming somatic cells, offer an alternative and have shown promising therapeutic effects, particularly in type I diabetes [80].”
Self-citationMukuba, D., Mallik, R., & Chowdhury, T. A. (2025) · Clinical Medicine · doi:10.1016/j.clinme.2025.100514 · Cited by 6
From survival to freedom: redefining success in type 1 diabetes
Piemonti, L. (2026) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(26)00003-3 · Cited by 4
Wu, X., Jin, S., Pan, Y., Zhen, W., Yu, S., Zhang, Y., Xu, F. Y., Wang, R., Wu, M., Sun, W., et al. (2026) · Stem Cell Research & Therapy · doi:10.1186/s13287-026-04997-4 · Cited by 7
“Deep learning-based image analysis can detect subtle drug effects on iPSC-derived cells, including cardiomyocytes, and classify toxic versus non-toxic responses with high accuracy [184, 185].”
Wu, S., Chandel, S., Bryzgalova, G., Efstathopoulos, P., Blust, K., Zhao, C., Erbil, E., Falk, A., Hedhammar, M., Berggren, P., et al. (2026) · Stem Cell Reports · doi:10.1016/j.stemcr.2026.102892 · Cited by 4
Self-citationAllogeneic Islet Transplantation: Chronicle of a Death Foretold?
Berney, T., Thaunat, O., & Berishvili, E. (2025) · Transplant International · doi:10.3389/ti.2025.14598 · Cited by 4
“%) and normal HbA1c [13].”
Barinova, A., Bogomolova, A. Y., Bogomazova, A., Borisova, A. A., Kiselev, S. L., & Panova, A. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26178749 · Cited by 4
“Despite the success of the 2024 case of autologous iPSC-derived islets restoring insulin independence [50], it is worth mentioning the fact that the patient required immunosuppressive therapy to protect the graft from autoimmune destruction.”
InfluentialStem cell islet replacement in type 1 diabetes: From “shelf” to “self”
de Koning, E. J. P., & Carlotti, F. (2024) · Cell stem cell · doi:10.1016/j.stem.2024.11.011 · Cited by 5
Advancing type 1 diabetes therapy: autologous islet transplant breakthrough
Zaki, R. A., & El‐Osta, A. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-02090-x · Cited by 5
Gilglioni, E. H., Bansal, M., St‐Pierre‐Wijckmans, W., Talamantes, S., Kasarinaite, A., Hay, D. C., & Gurzov, E. N. (2025) · Obesity Reviews · doi:10.1111/obr.13899 · Cited by 4
Improving chemical reprogramming strategies
Wang, Y., & Cheng, L. N. (2025) · Nature Reviews Molecular Cell Biology · doi:10.1038/s41580-025-00836-1 · Cited by 4
First-ever stem cell therapy restores insulin independence in type 1 diabetes: A medical milestone
Kumar, D., Tanwar, R., & Gupta, V. (2025) · World Journal of Stem Cells · doi:10.4252/wjsc.v17.i7.106856 · Cited by 4
Lietzke, A. C., Walker, E. M., Bealer, E. J., Crumley, K. M., King, J., Stendahl, A. M., Zhu, J., Pearson, G. L., Levi-D’Ancona, E., Henry-Kanarek, B. A., et al. (2024) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2024.07.26.605318 · Cited by 4
Antigen-specific T cell immunotherapy by in vivo mRNA deliveryPreprint
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Self-citationOrganoids, organs-on-chips, complex in vitro model: Definitions, applications, validation, ethics
Mottet, G., Grassart, A., Barthélemy, P., Antignac, C., Arrabal, S., BOURDIN, A. A., Descroix, S., Vos, J. D., Doutriaux, A., Fabrega, Q., et al. (2024) · Therapies · doi:10.1016/j.therap.2024.12.002 · Cited by 3
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Long, Y., Zou, Z., Wu, Y., Feng, H., Chen, T., Yang, Z., Jian, X., Yin, Y., & Li, X. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1605377 · Cited by 3
Monteiro, L. D. B., Archambault, A., Soukhatcheva, G., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1662986 · Cited by 3
The Current Treatment Landscape for Congenital Adrenal Hyperplasia
Tonge, J. J., Bacila, I. A., & Krone, N. P. (2025) · Drugs · doi:10.1007/s40265-025-02216-7 · Cited by 4
Kreis, N., Friemel, A., Ritter, A., Hentrich, A. E., Siebelitz, E., Louwen, F., & Yuan, J. (2025) · Communications Biology · doi:10.1038/s42003-025-08986-w · Cited by 5
“In further support, TGF β treatment resulted in reduced ciliary length by upregulating histone deacetylase 6 activityinhumanosteoblasts 83 ,orsuppressedthelevelsofIFT88mRNAand protein of murine chondrocytes 84 .”
DEC1 regulates human β cell functional maturation and circadian rhythm
Preza, S., Zheng, B., Gao, Z., Biju, A., Liu, M., Cheng, Z., Choi, M., & Alvarez‐Dominguez, J. R. (2025) · Cell Reports · doi:10.1016/j.celrep.2025.116666 · Cited by 4
“5,6 Yet, in vitro SC-islets are molecularly and functionally less mature than transplanted ones, 7–9 and both lack the kinetics, precision, and magnitude of glucose-stimulated insulin secretion (GSIS) of adult islets.”
Antioxidant Polymer Nanomaterials for Treatment of Type I Diabetes (T1D)
Nealy, S. L., Kozlovskaya, V., Mahr, A. R., Tse, H. M., & Kharlampieva, E. (2026) · Advanced Functional Materials · doi:10.1002/adfm.202526885 · Cited by 3
“While recent studies have successfully demonstrated the maturation of stem cell-derived islets into fully functional, insulin-producing cells in vivo, their phase I clinical trials are still in preliminary evaluation [76].”
Mitchell, W., de Magalhães, C. G., Tyshkovskiy, A., Uchida, Y., Goeminne, L. J. E., Ichimura, T., Ng, E. L., Moldakozhayev, A., Bonventre, J. V., & Gladyshev, V. N. (2026) · Aging Cell · doi:10.1111/acel.70390 · Cited by 4
“…et al. 2022; Liuyang et al. 2023; Wang et al. 2025). iPSCs generated through chemical reprogramming have further been differentiated to islet-like cells and autologously transplanted into a patient with Type 1 diabetes, resulting in sustained improvements in glycemic control (Wang et al. 2024).”
Overview of the major clinical trials investigating stem cells–based therapies for diabetes
Lin, T.-M., Lin, C.-H., Lin, C.-S., & Lin, C.-S. (2026) · Diabetes & Metabolism · doi:10.1016/j.diabet.2026.101738 · Cited by 4
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Self-citation
Metadata
- Authors
- Wang, S., Du, Y., Zhang, B., Meng, G., Liu, Z., Liew, S. Y., Liang, R., Zhang, Z., Cai, X., Wu, S., Gao, W., Zhuang, D., Zou, J., Huang, H., Wang, M., Wang, X., Wang, X., Liang, T., Liu, T., Gu, J., Liu, N., Wei, Y., Ding, X., Pu, Y., Zhan, Y., Luo, Y., Sun, P., Xie, S., Yang, J., Weng, Y., Zhou, C., Wang, Z., Wang, S., Deng, H., & Shen, Z.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peking University (CN)
- Nankai University (CN)
- Corresponding author
- Wang, Shusen
- Deng, Hongkui
- Shen, Zhongyang
- ORCID
- Venue
- Cell
- Publisher
- Elsevier BV
- Published
- 2024-10
- Volume
- 187
- Issue
- 22
- Pages
- 6152-6164.e18
- ISSN
- 0092-8674 (ISSN-L)
- OpenAlex
- W4402843606
- Semantic Scholar
- 53d12206f7b2371dbe9f6cc2db7448dfa741cad5
- Cited by
- 281
- References
- 70
- Citations by year
- 2026: 120 · 2025: 143 · 2024: 17
- FWCI
- 117.89
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (vor, 395 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- Locations
- Cell (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Natural Science Foundation of China (82070805, 32288102, 82100841, NKTM2023002)
- Tianjin Municipal Human Resources and Social Security Bureau (XB202011)
- Tianjin Municipal Science and Technology Bureau (22JCZXJC00110, 2023C03019)
- National Key Research and Development Program of China (2020YFA0803704)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pancreatic function and diabetes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Pluripotent Stem Cells Research
- Keywords
- type 1 diabetes, islet transplantation, autologous transplantation, anterior rectus sheath, insulin independence, glycemic control, HbA1c
- MeSH terms
- Single-Case Studies as Topic, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Insulin, Islets of Langerhans, Male, Islets of Langerhans Transplantation, Rectus Abdominis, Induced Pluripotent Stem Cells
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