Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes

Phase 1/2 Completed 8 enrolled University of Minnesota Juvenile Diabetes Research Foundation · collab Roche Pharma AG · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.

Timeline

Start: 2000-09
Primary completion: 2004-09
Completion: 2005-03

Publications

Results Hering BJ, Kandaswamy R, Ansite JD, Eckman PM, Nakano M, Sawada T, Matsumoto I, Ihm SH, Zhang HJ, Parkey J, Hunter DW, Sutherland DE. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes. JAMA. 2005 Feb 16;293(7):830-5. doi: 10.1001/jama.293.7.830.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allogeneic Islets of Langerhans	Cell therapy	7271 unknown	—

Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes

Summary

Timeline

Publications

Drugs

Indications