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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Juvenile Diabetes Research Foundation

Criteria

Inclusion:

• Primary islet allotransplant

• surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team

• Age 18 or older

• must give written informed consent