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

NCT00008801 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2005-11-01

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Insulin-Dependent
  • Diabetes Mellitus, Experimental
  • Transplantation, Homologous
  • Islets of Langerhans Transplantation

Interventions

DRUG

hOKT3gamma1 (Ala-ala)

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00008801 on ClinicalTrials.gov