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NCT00008801 Clinical Trial

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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00008801
Other study ID # NCRR-M01RR00400-0672
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received January 16, 2001
Last updated October 31, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• hOKT3gamma1 (Ala-ala)

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

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