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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: Clinical Trial Phase 2 study, sponsored by University of Miami.
NCT00315614 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.
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 |
Why NCT00315614 stopped before completion
NCT00315614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Islet Transplantation and Bone Marrow is the first listed.
NCT00315614 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00315614's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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