hOKT3γ1 (Ala-Ala) Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients

Phase 1/2 Completed 6 enrolled University of Minnesota Juvenile Diabetes Research Foundation · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2000-04
Primary completion: 2004-01
Completion: 2004-01

Publications

Results Hering BJ, Kandaswamy R, Harmon JV, Ansite JD, Clemmings SM, Sakai T, Paraskevas S, Eckman PM, Sageshima J, Nakano M, Sawada T, Matsumoto I, Zhang HJ, Sutherland DE, Bluestone JA. Transplantation of cultured islets from two-layer preserved pancreases in type 1 diabetes with anti-CD3 antibody. Am J Transplant. 2004 Mar;4(3):390-401. doi: 10.1046/j.1600-6143.2003.00351.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allogeneic Islets of Langerhans	Cell therapy	—	—
Subject	hOKT3γ1 (Ala-Ala)	Monoclonal antibody	—	—

hOKT3γ1 (Ala-Ala) Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients

Summary

Timeline

Publications

Drugs

Indications