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Pancreatic islet transplantation in type 1 diabetes: 20-year experience from a single-centre cohort in Canada
Open accessAbstract
Background Islet transplantation offers an effective treatment for selected people with type 1 diabetes and intractable hypoglycaemia. Long-term experience, however, remains limited. We report outcomes from a single-centre cohort up to 20 years after islet transplantation. Methods This cohort study included patients older than 18 years with type 1 diabetes undergoing allogeneic islet transplantation between March 11, 1999, and Oct 1, 2019, at the University of Alberta Hospital (Edmonton, AB, Canada). Patients who underwent islet-after-kidney transplantation and islet transplantation alone or islet transplantation before whole-pancreas transplantation (follow-up was censored at the time of whole-pancreas transplantation) were included. Patient survival, graft survival (fasting plasma C-peptide >0·1 nmol/L), insulin independence, glycaemic control, and adverse events are reported. To identify factors associated with prolonged graft survival, recipients with sustained graft survival (≥90% of patient follow-up duration) were compared with those who had non-sustained graft survival (<90% of follow-up duration). Multivariate binary logistic regression analyses were done to determine predictors of sustained graft survival. Findings Between March 11, 1999, and Oct 1, 2019, 255 patients underwent islet transplantation and were included in the analyses (149 [58%] were female and 218 [85%] were White). Over a median follow-up of 7·4 years (IQR 4·4-12·2), 230 (90%) patients survived. Median graft survival was 5·9 years (IQR 3·0-9·5), and graft failure occurred in 91 (36%) patients. 178 (70%) recipients had sustained graft survival, and 77 (30%) had non-sustained graft survival. At baseline, compared with patients with non-sustained graft survival, those with sustained graft survival had longer median type 1 diabetes duration (33·5 years [IQR 24·3-41·7] vs 26·2 years [17·0-35·5]; p=0·0003), median older age (49·4 years [43·5-56·1] vs 44·2 years [35·4-54·2]; p=0·0011), and lower median insulin requirements (0·53 units/kg per day [0·45-0·67] vs 0·59 units/kg per day [0·48-0·70]; p=0·032), but median HbA 1c concentrations were similar (8·2% [7·5-9·0] vs 8·5% [7·8-9·2]; p=0·23). 201 (79%) recipients had insulin independence, with a Kaplan-Meier estimate of 61% (95% CI 54-67) at 1 year, 32% (25-39) at 5 years, 20% (14-27) at 10 years, 11% (6-18) at 15 years, and 8% (2-17) at 20 years. Patients with sustained graft survival had significantly higher rates of insulin independence (160 [90%] of 178 vs 41 [53%] of 77; p<0·0001) and sustained improvements in glycaemic control mixed-main-effects model group effect, p<0·0001) compared with those with non-sustained graft survival. Multivariate analyses identified the combined use of anakinra plus etanercept (adjusted odds ratio 7·5 [95% CI 2·7-21·0], p<0·0001) and the BETA-2 score of 15 or higher (4·1 [1·5-11·4], p=0·0066) as factors associated with sustained graft survival. In recipients with sustained graft survival, the incidence of procedural complications was lower (23 [5%] of 443 infusions vs 17 [10%] of 167 infusions; p=0·027), whereas the incidence of cancer was higher (29 of [16%] of 178 vs four [5%] of 77; p=0·015) than in those with non-sustained graft survival; most were skin cancers (22 [67%] of 33). End-stage renal disease and severe infections were similar between groups. Interpretation We present the largest single-centre cohort study of long-term outcomes following islet transplantation. Although some limitations with our study remain, such as the retrospective component, a relatively small sample size, and the absence of non-transplant controls, we found that the combined use of anakinra plus etanercept and the BETA-2 score were associated with improved outcomes, and therefore these factors could inform clinical practice. Funding None.
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“Subsequent transplantation studies continued to show improved patient outcomes, with islet transplantation approaching the success of whole pancreas transplantation without the corresponding surgical risk.18–23”
From Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes (2023) · cites this paper as [20]
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“Controlled trials 62,63 and followup of recipients 64,65 in major centres showed that high rates of insulin independence can be reached, and long duration of graft function is also seen; however,”
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“In particular, graft success increases when a high number of islets are transplanted, often resulting in the need for multiple donor pancreases. 15,20,24”
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“Clinical trials also revealed that progressive graft dysfunction over time after intrahepatic islet transplantation and often requiring administration of exogenous insulin.(4,5,7) Importantly, the liver cannot accommodate encapsulated islets(8) or co-implantation of islets and immunomodulatory material for local immun…”
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Backgroundβ cell replacement therapy for the cure of diabetes
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“Islet cell [119 e 121] and whole pancreas [83,122 e 124] transplantation have both been shown to reduce hypoglycemia and restore glucose counter-regulation, and should be considered for individuals with type 1 diabetes who experience recurrent level 3 hypoglycemia (see “ Diabetes and…”
BackgroundSelf-citationCan fecal microbiota transplantations modulate autoimmune responses in type 1 diabetes?
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“122 Given the fact that anakinra did not seem to confer beta cell protection as a single agent in newly diagnosed T1D, this either suggests that etanercept had important (additive) effects, or that indeed the pathogenesis of graft rejection is distinct from the initial T1D pathophysiology.”
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Self-citationAdvancements in innate immune regulation strategies in islet transplantation
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“1 nmol/L), was 48% at 20 years after the first transplantation [2].”
BackgroundBioprinting and synthetic biology approaches to engineer functional endocrine pancreatic constructs.
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“According to a 20-year report of islet transplantation, signi fi cant progress has been made in improving graft survival and function, with advancements in immunosuppressive protocols and transplantation techniques contributing to better outcomes (5).”
BackgroundInfluentialNon-invasive quantification of stem cell-derived islet graft size and composition
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“Islet transplantation is limited by the scarcity of cadaveric islets, as usually at least two donors are required per individual [1].”
BackgroundSuccessful Islet Transplantation Into a Subcutaneous Polycaprolactone Scaffold in Mice and Pigs
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“Islet transplantation (ITx) has shown to be a highly effective treatment for type 1 diabetes mellitus (T1D) in patients with hypoglycemia and brittle disease [85].”
BackgroundSelf-citationPDX1+ cell budding morphogenesis in a stem cell-derived islet spheroid system
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“In the last 20 years, these islets have been successfully implanted in human subjects, albeit the approach is heavily constrained by a lack of donor organs and an extensive immunosuppressant regimen required for the patient post-implantation [5, 6].”
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Insulin independence following islet transplantation improves long‐term metabolic outcomes
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“8,9,16 Insulin independence has since become increasingly reported in the literature.”
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“Recent data have demonstrated that median islet graft survival is approximately 6 years while insulin independence declines from approximately 60% at 1 year to 20% at 5 years and less than 10% at 20 years post-transplantation [9].”
BackgroundAdvances 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
“In parallel, bioengineered encapsulation and oxygenation devices incorporating pro-angiogenic or oxygen-releasing biomaterials enhance graft survival and scalability 34 .”
CCL22-expressing Stem Cell–derived Islet Grafts Recruit Regulatory T Cells in Mice
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Beyond cancer: The potential application of CD47-based therapy in non-cancer diseases
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Recent Developments in Islet Biology: A Review With Patient Perspectives
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“Nor was there any protection from hypoglycemia which is maintained in 80% of islet recipients unless islet graft function is lost (84).”
BackgroundResultSelf-citationThe concept of immunothrombosis in pancreas transplantation
Masset, C., Drillaud, N., Ternisien, C., Degauque, N., Gérard, N., Bruneau, S., Branchereau, J., Blancho, G., Mesnard, B., Brouard, S., et al. (2024) · American Journal of Transplantation · doi:10.1016/j.ajt.2024.11.025 · Cited by 8
Parente, A., Verhoeff, K., Kin, T., Hefler, J., Marfil-Garza, B., Sanchez-Fernandez, N., Lam, A., Lyon, J., O'Gorman, D., Dajani, K. Z., et al. (2024) · Transplantation Direct · doi:10.1097/txd.0000000000001667 · Cited by 6
“Considering the benefits of ITx in the treatment of type 1 diabetes, 8,16 the applications of ITx after DCD-V are potentially relevant to increase the donor pool.”
BackgroundSelf-citationLi, J., Fang, Y., Wu, Z.-H., Shang, L.-R., & Li, L. (2024) · Materials Futures · doi:10.1088/2752-5724/ad47ce · Cited by 6
Park, H.-S., Lee, E., You, Y., Rhee, M., Kim, J.-M., Hwang, S.-S., & Lee, P.-Y. (2024) · Journal of Diabetes Investigation · doi:10.1111/jdi.14216 · Cited by 6
Chetboun, M., Masset, C., Maanaoui, M., Defrance, F., Gmyr, V., Raverdy, V., Hübert, T., Bonner, C., Supiot, L., Kerleau, C., et al. (2023) · Transplant International · doi:10.3389/ti.2023.11950 · Cited by 8
“Although partial islet graft function is suf fi cient to suppress severe hypoglycemia [15], multiple islet infusions are often required to achieve sustained insulin independence [16 – 18].”
BackgroundVerhoeff, K. K., Marfil‐Garza, B. A., Dajani, K. Z., Bigam, D. L., Anderson, B. L., Kin, T., Lam, A. P., O’Gorman, D., Senior, P. A., & Shapiro, A. M. J. (2022) · Transplantation · doi:10.1097/tp.0000000000004328 · Cited by 7
Self-citationImmune 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
Modulating immune response for the prevention and treatment of type 1 diabetes
Vohidova, D., Desai, P., Lozano, A. M., & Omid Veiseh, A. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1715863 · Cited by 5
Engineering hypoimmune stem cell-derived beta cells
Licht, B. J. M., Duffy, G. P., & Levey, R. E. (2025) · Stem Cell Research & Therapy · doi:10.1186/s13287-025-04745-0 · Cited by 8
“The median longevity of islet grafts in the clinical context is approximately 5.9 years [70].”
InfluentialBae, J. H., Choe, H. J., Yang, Y., Seo, M. H., Choi, J. H., Kim, G., Lyu, Y. S., Han, J. H., Kang, S., Kim, W. J., et al. (2025) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2025.0739 · Cited by 5
“In selected cases, pancreatic islet transplantation can be considered [48].”
Biotechnology Revolution Shaping the Future of Diabetes Management
Kundnani, N. R., Lolescu, B. M., Dinu, A. R., Berceanu-Vaduva, D. M., Dumitrescu, P., Tamaș, T.-P., Sharma, A., & Popa, M.-D. (2024) · Biomolecules · doi:10.3390/biom14121563 · Cited by 6
Cai, X., Cao, J.-L., Wang, L., Zou, J.-Q., Li, R., Sun, P., Ding, X.-J., Zhang, B., Liu, Z.-W., Pei, X.-R., et al. (2024) · Transplantation · doi:10.1097/tp.0000000000004949 · Cited by 5
“2 However, the outcome of islet transplantation varies with the quality of the donor islets, which can be compromised by several factors before transplantation, including cold-ischemic injury.”
Pilz, J., Gloddek, N., Lindheimer, F., Lindner, M., Puhr-Westerheide, D., Ümütlü, M., Cyran, C., Seidensticker, M., Lindner, R. J., Kraetzl, M., et al. (2024) · American Journal of Transplantation · doi:10.1016/j.ajt.2024.02.026 · Cited by 5
Yabe, S., Fukuda, S., Nishida, J., Takeda, F., & Okochi, H. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e19972 · Cited by 5
Waris, S., Begam, H. H., Kumar, M. P., Abdulrasool, Z., Avudaiappan, M., Butler, A. E., & Nandakumar, M. (2026) · Cells · doi:10.3390/cells15020191 · Cited by 6
Allogeneic 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
Perrier, Q., Noble, J., & Lablanche, S. (2025) · Transplantation reviews · doi:10.1016/j.trre.2025.100913 · Cited by 4
Long-term outcomes and challenges of islet transplantation in type 1 diabetes
Chetboun, M., & Pattou, F. N. (2025) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(25)00003-8 · Cited by 6
Nanno, Y., Hodges, J. S., Freeman, M. L., Trikudanathan, G., Schwarzenberg, S., Downs, E. M., Ramanathan, K., Pruett, T., Beilman, G. J., Chinnakotla, S., et al. (2023) · Transplantation Direct · doi:10.1097/txd.0000000000001561 · Cited by 4
“38 Exogenous insulin treatment during the early stage of engraftment improves the outcome of islet transplantation by minimizing the workload experienced by the transplanted grafts and is therefore considered to be of great importance.”
BackgroundVerhoeff, K., Cuesta-Gomez, N., Albers, P., Pawlick, R., Marfil-Garza, B., Jasra, I., Dadheech, N., O'Gorman, D., Kin, T., Halpin, A., et al. (2022) · Transplantation · doi:10.1097/tp.0000000000004347 · Cited by 4
“Optimal clinical outcomes are independently and strongly associated with β-cell mass and islet engraftment as measured by C-peptide levels.(3) To limit acute immune-mediated islet destruction following transplant, recipients are evaluated for allosensitization to HLAs and transplanted with ABO-compatible (ABOc) islet…”
BackgroundSelf-citationFrom 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
Strakosch, T., & Forbes, S. (2026) · Diabetic Medicine · doi:10.1111/dme.70230 · Cited by 3
“This is because wider eligibility will lead to more patients undergoing the procedure and islet function, even with human islet donor grafts, typically wanes after > 5 years 22,34 although large variability exists.”
Regenerative medicine approaches for treating diabetes: Current advances and future directions
Medenica, S., Abazović, D., Vuković, J., Vojinović, T., Tomović, F., Defeudis, G., Mazzilli, R., Kovačević, Z., Djurdjic, D., Prelević, V., et al. (2025) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2025.109232 · Cited by 4
Impact of Islet Transplantation on Type 1 Diabetes-Related Complication: A Systematic Review
Gariani, K., Peloso, A., Haidar, F., Kumar, R., Wassmer, C., Morabito, M., Krause, N., Compagnon, P., Berishvili, E., & Berney, T. (2025) · Transplant International · doi:10.3389/ti.2025.15091 · Cited by 3
“This proportion declined to around 30% at 5 years and to approximately 20% by 10 years [8].”
InfluentialKawai, K., Doğan, F., Alagpulinsa, D. A., Pop, R., Veres, A., Sobell, D., Deng, H., Collins, S. H., Zhang, J., Chapin, M. H., et al. (2025) · Xenotransplantation · doi:10.1111/xen.70098 · Cited by 2
“Replacement of pancreatic beta cells by transplantation of deceased donor islets has been demonstrated to restore physiological glucose control and insulin independence for patients with T1D, thus providing a functional cure [1, 2].”
Zhan, Y., Du, X., Li, Y., Wang, Y., Cai, X., Yang, R., Jiang, T., Liu, Z., Yu, X., Lin, S.-S., et al. (2025) · Cell Transplantation · doi:10.1177/09636897251374147 · Cited by 3
“In some experienced medical centers, the median graft survival is more than 5 years 3,4 .”
Navigating challenges in human pluripotent stem cell-derived islet therapy for type 1 diabetes
Usama, M., Deng, Y., Chen, Y., Milland, T., Malleshaiah, M. K., & Aghazadeh, Y. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1625439 · Cited by 4
Perrier, Q., Lablanche, S., Rakotoarisoa, L., Villard, O., Riveline, J., Julla, J., Buron, F., Reffet, S., Renard, E., Kessler, L., et al. (2025) · Diabetes & Metabolism · doi:10.1016/j.diabet.2025.101654 · Cited by 3
Sex Differences in Maturation and Function of Neonatal Porcine Islets Upon Transplantation in Mice
Cuesta‐Gomez, N., Castro, C., Rosko, M., Seeberger, K. L., & Korbutt, G. S. (2025) · Xenotransplantation · doi:10.1111/xen.70039 · Cited by 4
“Islet transplantation (ITx) has established that cellular therapies can improve glycemic control in a subset of patients with type 1 diabetes, but it is limited by the shortage of adequate donor islets and need for chronic immunosuppression [1, 2].”
EndoC-βH3 pseudoislets are suitable for intraportal transplantation in diabetic mice
Zhou, M., Linn, T., & Petry, S. F. (2024) · Islets · doi:10.1080/19382014.2024.2406041 · Cited by 3
Islet transplantation in Korea
Lee, J., & Yoon, K.-H. (2024) · Journal of Diabetes Investigation · doi:10.1111/jdi.14264 · Cited by 3
“In contrast, recent studies from Western countries have reported promising long-term outcomes 18, 19 .”
BackgroundResultCaldara, R., Tomajer, V., & Piemonti, L. (2023) · Transplant International · doi:10.3389/ti.2023.11565 · Cited by 3
Juang, J., Chen, C.-L., Kao, C.-W., Chen, C.-Y., Shen, C.-R., Wang, J.-J., Tsai, Z., & Chu, I. (2023) · Polymers · doi:10.3390/polym15122584 · Cited by 3
“Although most human islet transplantation attains insulin independence at one year [3,4], the successful rate gradually decreases with time [5,6].”
BackgroundNoninvasive quantitative evaluation of viable islet grafts using 111In‐exendin‐4 SPECT/CT
Botagarova, A., Murakami, T., Fujimoto, H., Fauzi, M., Kiyobayashi, S., Otani, D., Fujimoto, N., & Inagaki, N. (2023) · The FASEB Journal · doi:10.1096/fj.202201787rr · Cited by 3
Pancreatic islet transplantation in type 1 diabetes: Current state and future perspectives
Kuo, C.-H., & Li, H.-Y. (2022) · Journal of Diabetes Investigation · doi:10.1111/jdi.13942 · Cited by 3
“3 ng/ mL).(1) Furthermore, as the cut-off value for C-peptide level is higher in the Igls criteria (0.”
BackgroundResultInfluentialRegenerative macrophages enhance stem cell–derived β cell function and engraftment
Freitas, B. F. A., Fox, S. A., Orban, P. C., Velghe, J., Mojibian, M., Dai, D., Soukhatcheva, G., Lynn, F. C., Levings, M. K., & Verchere, C. B. (2026) · Science Advances · doi:10.1126/sciadv.aed4221 · Cited by 3
“Follow-up studies of the Edmonton Protocol reported 50 to 70 % insulin independence 5 years following transplantation, with some individuals remaining insulin independent after 20 years ( 6 , 8 ).”
InfluentialBrandhorst, D., Brandhorst, H., Domingo-Lopez, D., O'Cearbhaill, E., Coulter, F., Spiers, R. M., Deotti, S., Kelly, H., Duffy, G., & Johnson, P. R. V. (2025) · Bioengineering · doi:10.3390/bioengineering13010056 · Cited by 2
Pathak, S., Iliopoulou, B. P., Mosher, B., Wells, A., Witherspoon, L., Bader, C. S., Chen, P.-I., Regmi, S., Gupta, B., Dutt, S., et al. (2025) · American Journal of Transplantation · doi:10.1016/j.ajt.2025.10.010 · Cited by 2
Cell therapy for type 1 diabetes: Tracing historical progress and exploring emerging technologies
Perrier, Q., Lablanche, S., & Benhamou, P. (2025) · Cell Transplantation · doi:10.1177/09636897251394787 · Cited by 3
β-Cell Benchmarks: Defining Predictive Outcomes in Islet Transplantation
Forbes, S. (2025) · Diabetes · doi:10.2337/dbi24-0054 · Cited by 2
Anazawa, T., Marubashi, S., Kodama, S., Goto, M., Maruyama, M., Eguchi, H., Shimoda, M., Noguchi, H., Yamaguchi, T., Ito, T., et al. (2025) · Transplantation Direct · doi:10.1097/txd.0000000000001765 · Cited by 2
Witkowski, P., Wojcik, N., Appelbaum, N., Fung, J. J., Barth, R., & Ricordi, C. (2025) · Frontiers in Transplantation · doi:10.3389/frtra.2025.1491568 · Cited by 2
A differentiation protocol for generating pancreatic delta cells from human pluripotent stem cells
Zhang, T., Wang, N., Liao, Z., Chen, J., Meng, H., Lin, H., Xu, T., Chen, L., Zhu, L., & Liu, H. (2024) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2024.1490040 · Cited by 3
Metadata
- Authors
- Marfil-Garza, B. A., Imes, S., Verhoeff, K., Hefler, J., Lam, A., Dajani, K., Anderson, B., O'Gorman, D., Kin, T., Bigam, D., Senior, P. A., & Shapiro, A. M. J.
- Affiliations
- University of Alberta (CA)
- Corresponding author
- Shapiro, A M James
- ORCID
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2022-07
- Volume
- 10
- Issue
- 7
- Pages
- 519-532
- ISSN
- 2213-8587 (ISSN-L)
- OpenAlex
- W4280558719
- Cited by
- 205
- References
- 0
- Citations by year
- 2026: 42 · 2025: 52 · 2024: 51 · 2023: 43 · 2022: 17
- FWCI
- 38.95
- 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/ (am, 174 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
- The Lancet Diabetes & Endocrinology (acceptedVersion)
- PubMed (publishedVersion)
- Funders
- Immune Tolerance Network
- University of Alberta
- National Institute of Diabetes and Digestive and Kidney Diseases
- Canada Research Chairs
- Juvenile Diabetes Research Foundation Canada
- Alberta Diabetes Foundation
- Diabetes Canada
- Government of Alberta
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pancreatic function and diabetes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- islet transplantation, type 1 diabetes, graft survival, insulin independence, C-peptide, long-term outcomes, hypoglycemia, glycemic control, patient survival, islet graft failure
- MeSH terms
- Etanercept, Diabetes Mellitus, Type 1, Female, Graft Survival, Humans, Insulin, Male, Retrospective Studies, Cohort Studies, Islets of Langerhans Transplantation, Treatment Outcome, Interleukin 1 Receptor Antagonist Protein
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