hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Experimental, Transplantation, Homologous, Islets of Langerhans Transplantation

In brief

The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.

Key facts

Study ID

NCT00008801

Run by

National Center for Research Resources (NCRR)

Last updated by the study team

2005-11-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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