Type 1 Diabetes Clinical Trial
Official title:
hOKT3γ1 (Ala-Ala) Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients
The collective effects of two-layer pancreas preservation, pretransplant islet culture, day -2 pretransplant immunosuppression, and induction immunosuppression with the FcR-nonbinding anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala)to facilitate diabetes reversal after single-donor islet transplantation.
This is an open-label, one-year follow-up study of type 1 diabetic islet allograft
recipients who receive FcR non-binding OKT3 antibody hOKT3γ1 (Ala-Ala) plus sirolimus
induction immunotherapy combined with sirolimus and delayed tacrolimus maintenance
immunosuppression. Six subjects were transplanted.
The premise behind the proposal is that hOKT3γ1(Ala-Ala) corrects the imbalance between
autoreactive and regulatory T cells and consequently prevents autoimmune destruction of
transplanted islets. To prevent allorejection, hOKT3γ1(Ala-Ala)was combined with sirolimus
and delayed tacrolimus. Additionally, the safety and efficacy of the maintenance
immunosuppressive regimen of sirolimus combined with tacrolimus was monitored.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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