Human islet transplantation network for the treatment of Type I diabetes: first data from the Swiss-French GRAGIL consortium (1999-2000)

Aims/hypothesis. Improvements in islet transplantation require clinical ser ies large enough to implement controlled new strategies. The goal of this s tudy was to demonstrate the feasibility of a multicentre network for islet transplantation in Type I (insulin-dependent) diabetic patients. Methods. The five centres (Besancon, Geneva, Grenoble, Lyon, Strasbourg;) o f the GRAGIL network allow pancreas procurement, recipient recruitment, tra nsplantation procedure and follow-up. Islet isolation is, however, performe d in one single laboratory (Geneva). Pancreata were procured in each of the five centres and transported to Geneva with an ischaemia time of less than 8 hours. Islets were isolated using a standard automated method. If the is let number was too low for a graft ( < 6000 Islet-equivalent/kg), islets we re cultured up to 12 days until another isolation was possible. Islets were transplanted by percutaneous transhepatic intraportal injection. Immunosup pression consisted of cyclosporine, mycophenolate mofetil, steroids and an anti-interleukin 2 receptor antibody. Results. From March 1999 to June 2000, 56 pancreata procurements were perfo rmed with an average yield of 234 500 islet-equivalent, with 32 preparation s over 200000 islet-equivalent. Ten C-peptide negative Type I diabetic pati ents (5 men and 5 women, median age 44 years, median diabetes duration 29 y ears) with an established kidney graft (> 6 months) received 9030 +/- 1090 islet-equivalent/kg with a median purity of 63%. The number of pancreata re quired for each graft was 1 (n=5) or 2 (n=5). At the completion of a 12 mon th follow-up, we observed 0% primary nonfunction, 50% graft survival and 20 % insulin-independence. Conclusions/interpretation. This study demonstrates the interest and the fe asibility of a multicentre collaboration in human islet transplantation.