[HTML][HTML] International trial of the Edmonton protocol for islet transplantation
AMJ Shapiro, C Ricordi, BJ Hering… - … England Journal of …, 2006 - Mass Medical Soc
AMJ Shapiro, C Ricordi, BJ Hering, H Auchincloss, R Lindblad, RP Robertson, A Secchi…
New England Journal of Medicine, 2006•Mass Medical SocBackground 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 …
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 …
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.)
The New England Journal Of Medicine