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

October 31, 2005 updated by: National Center for Research Resources (NCRR)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Juvenile Diabetes Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 16, 2001

First Submitted That Met QC Criteria

January 17, 2001

First Posted (Estimate)

January 18, 2001

Study Record Updates

Last Update Posted (Estimate)

November 1, 2005

Last Update Submitted That Met QC Criteria

October 31, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00400-0672

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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