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MGA031, Sirolimus and Tacrolimus in Islet Transplantation

NCT00265473 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-03-09

Study results available
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Summary

This clinical trial is designed to extend the observations made in our pilot clinical trial (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus in preventing rejection and autoimmune destruction of deceased donor pancreatic islet transplants in type 1 diabetic recipients.

Conditions

Interventions

BIOLOGICAL

Allogeneic Islets of Langerhans

Intraportal infusion of islets of Langerhans

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Bernhard J. Hering, M.D. · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2010-05-31
Completion
2010-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00265473 on ClinicalTrials.gov