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Cited by 205Pancreatic function and diabetesDiabetes and associated disordersDiabetes Management and Research

Pancreatic islet transplantation in type 1 diabetes: 20-year experience from a single-centre cohort in Canada

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Marfil-Garza, Braulio A, Imes, Sharleen, Verhoeff, Kevin, Hefler, Joshua, Lam, Anna, Dajani, Khaled, Anderson, Blaire, O'Gorman, Doug +4 more·2022·The Lancet Diabetes & Endocrinology
DOI 10.1016/s2213-8587(22)00114-0
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Abstract

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 showed improved patient outcomes, with islet transplantation approaching the success of whole pancreas transplantation without the corresponding surgical risk.

    “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]

    The Methods findings (page unavailable) report insulin independence and sustained improvements in glycaemic control after islet transplantation. They do not establish that its success approaches whole-pancreas transplantation or that it avoids the corresponding surgical risk; the study did not compare those procedures. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • Controlled trials and follow-up of recipients in major centres showed that high rates of insulin independence can be reached, and long duration of graft function is also seen.

    “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,”

    From The future of type 1 diabetes therapy (2025) · cites this paper as [65]

  • Graft success increases when a high number of islets are transplanted, often resulting in the need for multiple donor pancreases.

    “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”

    From Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes (2023) · cites this paper as [20]

    The Methods and Findings passages report graft survival and factors associated with sustained survival, but do not link success to the number of islets transplanted. Searches for islet mass, islet equivalents, and multiple donor pancreases found no passage establishing that relationship or the claimed need for multiple donors; a relevant study appears only in the References. (LLM, conf=0.72)

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Research works printed but not linked: 2

  1. [11]11. Lemos, JRN ∙ Baidal, DA ∙ Ricordi, C ∙ et al. Survival after islet transplantation in subjects with type 1 diabetes: twenty-year follow-up Diabetes Care. 2021; 44:e67-e68 Crossref Scopus (10) PubMed Google Scholar
  2. [32]32. Rickels, MR ∙ Stock, PG ∙ de Koning, EJP ∙ et al. Defining outcomes for β-cell replacement therapy in the treatment of diabetes: a consensus report on the Igls criteria from the IPITA/EPITA opinion leaders workshop Transpl Int. 2018; 31:343-352 Crossref Scopus (76) PubMed Google Scholar Figures (3) Article metrics Supplementary material (1) PDF (1.43 MB)

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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)
DOI
10.1016/s2213-8587(22)00114-0
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
Licence
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 › Surgery › 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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