drugset / Trial / NCT01060605
Pre Transplant Rapamycin Treatment in Islet Transplantation Alone
Phase 3
Completed
11 enrolled
IRCCS San Raffaele
Juvenile Diabetes Research Foundation · collabMinistry of Education, Universities and Research, Italy · collabTelethon-JDRF Center for Beta cell replacement: clinical core. · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2001-10
- Primary completion
- 2005-12
- Completion
- 2009-09
Publications
- Benedini S, Ermetici F, Briganti S, Codella R, Terruzzi I, Maffi P, Caldara R, Secchi A, Nano R, Piemonti L, Alejandro R, Ricordi C, Luzi L. Insulin-mimetic effects of short-term rapamycin in type 1 diabetic patients prior to islet transplantation. Acta Diabetol. 2018 Jul;55(7):715-722. doi: 10.1007/s00592-018-1141-z. Epub 2018 Apr 13.
- Piemonti L, Maffi P, Monti L, Lampasona V, Perseghin G, Magistretti P, Secchi A, Bonifacio E. Beta cell function during rapamycin monotherapy in long-term type 1 diabetes. Diabetologia. 2011 Feb;54(2):433-9. doi: 10.1007/s00125-010-1959-6. Epub 2010 Nov 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | 0.1 mg/kg | — |