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Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus

NCT00315614 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-04-04

Study results available
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Summary

SPECIFIC AIMS:

* To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation.
* To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression.
* To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus.
* To determine whether the natural history of the microvascular, macrovascular and neuropathic complications are altered following successful transplantation of islet

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Islet Transplantation and Bone Marrow

Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Diabetes Research Institute Foundation

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Rodolfo Alejandro, MD · 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
2000-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT00315614 on ClinicalTrials.gov