Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes

NCT00285233 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-08-02

No results posted yet for this study

Summary

The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.

Conditions

Interventions

BIOLOGICAL

Allogeneic islets of Langerhans transplant

Allogeneic islets of Langerhans transplant

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY
  • Juvenile Diabetes Research Foundation

    collaborator OTHER
  • University of Minnesota

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2004-09-30
Completion
2005-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00285233 on ClinicalTrials.gov