Type 1 Diabetes Clinical Trial
Official title:
Alemtuzumab Induction With Tacrolimus and MMF Maintenance Immunosuppression in Islet Transplantation
Our experience suggests that further research with alemtuzumab is attractive in islet transplantation. Therefore, in this study we propose to combine alemtuzumab induction pre-transplant, with tacrolimus and mycophenolate mofetil maintenance immunosuppression post-transplant. In the critical early phase post transplant, we anticipate that this regimen will prove to be more effective in control of autoimmunity or rejection events, and have a more desirable side-effect profile, than previously tested combinations of induction and immunosuppressive agents.
This trial is a single-center, prospective, open-label study in 12 Type 1 diabetic
participants receiving an islet-alone transplant along with alemtuzumab induction therapy
followed by combination tacrolimus and MMF maintenance immunosuppression. Participants will
receive 1 to 3 infusions of pancreatic islets of sufficient quantity to attain insulin
independence.
The primary objective of this protocol is to assess the safety of a treatment regimen
utilizing alemtuzumab induction and a combination of tacrolimus and MMF maintenance
immunosuppression in adult Type 1 diabetic participants receiving their first islet
transplant.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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