Pre Transplant Rapamycin Treatment in Islet Transplantation Alone

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Numerous changes to the original Edmonton protocol have been proposed in the attempt of improving the still unsatisfactory long-term function of ITA. Rapamycin may blunt the early inflammatory response to islet transplantation in the liver, thus favoring islet engraftment.

Aim of the investigators study was to evaluate the effect of a pre-transplant treatment with rapamycin in patients with type 1 diabetes receiving islet transplant alone and immunosuppression according to the Edmonton protocol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Collaborators: Juvenile Diabetes Research Foundation; Ministry of Education, Universities and Research, Italy; Telethon-JDRF Center for Beta cell replacement: clinical core.
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• type 1 diabetes

• ≥5 years of type 1 diabetes

• hypoglycaemia unawareness

• progression of chronic complications of diabetes despite intensive insulin regimen

Exclusion Criteria:

• overt kidney disease

• chronic liver disease

• hepatic haemangioma

• severe cardiomyopathy

• untreated coronary artery disease