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NCT00315614 · ClinicalTrials.gov registry record · Phase 2
Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00315614 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 3 participants.
The verdict
NCT00315614, a Phase 2 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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
Interventions
- BIOLOGICAL Islet Transplantation and Bone Marrow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2000-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315614
The ClinicalTrials.gov registry entry for NCT00315614 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Islet Transplantation and Bone Marrow is the first listed.
NCT00315614 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315614 about?
NCT00315614 is a clinical study titled "Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus". 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 mar...
What is the current status of trial NCT00315614?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2000-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00315614?
The interventions under investigation include: Islet Transplantation and Bone Marrow (BIOLOGICAL).
Who is sponsoring clinical trial NCT00315614?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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