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NCT00315627 · ClinicalTrials.gov registry record · Phase 2
Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation
A Phase 2 study, sponsored by Rodolfo Alejandro.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00315627: Completed Phase 2 study, sponsored by Rodolfo Alejandro.
NCT00315627 is a Phase 2 study that has completed, run by Rodolfo Alejandro. 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
NCT00315627, a Phase 2 study, has completed, sponsored by Rodolfo Alejandro.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
Number of subjects at 1 year with HbA1c \< 6.5% and absence of severe hypoglycemia
Interventions
- DRUG Islet transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2005-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT00315627 record still lists
NCT00315627 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 is the first listed.
NCT00315627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315627 about?
NCT00315627 is a clinical study titled "Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation". 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 pat...
What is the current status of trial NCT00315627?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2005-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00315627?
The interventions under investigation include: Islet transplantation (DRUG).
Who is sponsoring clinical trial NCT00315627?
This trial is sponsored by Rodolfo Alejandro, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00315627'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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