International trial of the Edmonton protocol for islet transplantation
Open accessAbstract
BACKGROUND: Islet transplantation offers the potential to improve glycemic control in a subgroup of patients with type 1 diabetes mellitus who are disabled by refractory hypoglycemia. We conducted an international, multicenter trial to explore the feasibility and reproducibility of islet transplantation with the use of a single common protocol (the Edmonton protocol). METHODS: We enrolled 36 subjects with type 1 diabetes mellitus, who underwent islet transplantation at nine international sites. Islets were prepared from pancreases of deceased donors and were transplanted within 2 hours after purification, without culture. The primary end point was defined as insulin independence with adequate glycemic control 1 year after the final transplantation. RESULTS: Of the 36 subjects, 16 (44%) met the primary end point, 10 (28%) had partial function, and 10 (28%) had complete graft loss 1 year after the final transplantation. A total of 21 subjects (58%) attained insulin independence with good glycemic control at any point throughout the trial. Of these subjects, 16 (76%) required insulin again at 2 years; 5 of the 16 subjects who reached the primary end point (31%) remained insulin-independent at 2 years. CONCLUSIONS: Islet transplantation with the use of the Edmonton protocol can successfully restore long-term endogenous insulin production and glycemic stability in subjects with type 1 diabetes mellitus and unstable control, but insulin independence is usually not sustainable. Persistent islet function even without insulin independence provides both protection from severe hypoglycemia and improved levels of glycated hemoglobin. (ClinicalTrials.gov number, NCT00014911 [ClinicalTrials.gov].).
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A subsequent international multicentre study showed unevenness of results between centres, indicating a need for high-quality islet isolation.
“These findings were supported in a subsequent international multicentre study, which showed some unevenness of results between centres that indicated a need for highquality islet isolation.60”
From The future of type 1 diabetes therapy (2025) · cites this paper as [60]
The Outcomes (p. 8) report substantial site-to-site variation, and the Discussion (p. 11) links it to differing experience with islet processing, transplantation, and immunosuppressive therapy. The Study Design (p. 3) requires sites to demonstrate consistent islet preparation under Good Manufacturing Practice conditions. The paper supports the importance of preparation quality, but does not establish that inadequate islet isolation specifically caused the uneven results. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIllness from immunosuppression and scarce donor islets limit how many patients can benefit from islet transplantation.
“Moreover, morbidity associated with immunosuppression and limitations in the supply of donor islets restricts the number of people who can benefit from islet transplantation.161”
From Type 1 diabetes (2018) · cites this paper as [161]
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- Authors
- Shapiro, A. M. J., Ricordi, C., Hering, B. J., Auchincloss, H., Lindblad, R., Robertson, R. P., Secchi, A., Brendel, M. D., Berney, T., Brennan, D. C., Cagliero, E., Alejandro, R., Ryan, E. A., DiMercurio, B., Morel, P., Polonsky, K. S., Reems, J.-A., Bretzel, R. G., Bertuzzi, F., Froud, T., Kandaswamy, R., Sutherland, D. E. R., Eisenbarth, G., Segal, M., Preiksaitis, J., Korbutt, G. S., Barton, F. B., Viviano, L., Seyfert-Margolis, V., Bluestone, J., & Lakey, J. R. T.
- Affiliations
- University of Alberta (CA)
- University of Miami (US)
- University of Minnesota (US)
- Harvard University (US)
- Emmes (United States) (US)
- University of Washington (US)
- Justus-Liebig-Universität Gießen (DE)
- University of Geneva (CH)
- Washington University in St. Louis (US)
- National Institute of Allergy and Infectious Diseases (US)
- University of Colorado Boulder (US)
- Immune Tolerance Network (US)
- ORCID
- Shapiro, A.M. James
- Ricordi, Camillo
- Hering, Bernhard J.
- Robertson, R. Paul
- Secchi, Antonio
- Berney, Thierry
- Brennan, Daniel C.
- Alejandro, Rodolfo
- Ryan, Edmond A.
- Morel, Philippe
- Bertuzzi, Federico
- Kandaswamy, Raja
- Sutherland, David E.R.
- Preiksaitis, Jutta
- Korbutt, Gregory S.
- Barton, Franca B.
- Bluestone, Jeffrey
- Lakey, Jonathan R.T.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2006-09-28
- Volume
- 355
- Issue
- 13
- Pages
- 1318-1330
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2006919788
- Cited by
- 1,942
- References
- 40
- Citations by year
- 2026: 33 · 2025: 45 · 2024: 42 · 2023: 60 · 2022: 65 · 2021: 82 · 2020: 100 · 2019: 85 · 2018: 90 · 2017: 80 · 2016: 101 · 2015: 91 · 2014: 97 · 2013: 123 · 2012: 145
- FWCI
- 140.30
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Archive ouverte UNIGE (University of Geneva) (publishedVersion, other-oa)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
- 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, Edmonton protocol, type 1 diabetes, insulin independence, glycemic control, refractory hypoglycemia, islet graft function, graft loss, HbA1c
- MeSH terms
- Insulin Secretion, Adult, Blood Glucose, C-Peptide, Diabetes Mellitus, Type 1, Feasibility Studies, Follow-Up Studies, Humans, Hypoglycemic Agents, Immunosuppressive Agents, Infusions, Intravenous, Insulin, Isoantibodies, Middle Aged, Opportunistic Infections, Portal Vein, Reproducibility of Results, Islets of Langerhans Transplantation, Transplantation Conditioning
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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