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Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation

NCT00315627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-05-25

Study results available
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Summary

The purposes of this study are:

1. To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor free immunosuppression.
2. To assess the long-term function of successful islet transplants in patients with type 1 diabetes mellitus utilizing islets that have undergone a period of culture.
3. To determine whether the natural history of the microvascular, macrovascular, and neuropathic complications are altered following the successful transplantation of islets.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Islet transplantation

Islet transplantation

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Rodolfo Alejandro

    lead OTHER

Principal Investigators

  • Rodolfo Alejandro, M.D. · Diabetes Research Institute - University of Miami

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
2005-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

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 NCT00315627 on ClinicalTrials.gov