Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, insulin-dependent, diabetes mellitus, experimental, transplantation, homologous, islets of langerhans transplantation
Treatment hokt3gamma1 (ala-ala)
Phase phase 1/phase 2
Sponsor National Center for Research Resources (NCRR)
Collaborator Juvenile Diabetes Research Foundation
Trial identifier NCT00008801, NCRR-M01RR00400-0672

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
Description Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by National Center for Research Resources (NCRR).