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NCT00437398 · ClinicalTrials.gov registry record · Phase 1
Islet Transplantation for Type 1 Diabetes Mellitus
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00437398: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT00437398 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00437398, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time, associated with an increased risk of severe hypoglycemia and implemented by less than 50 % of the population of such patients. Outcomes of transplantation of isolated human islets have substantially improved and been performed at about 40 institutions around the world. We are proposing a clinical phase 1/phase 2 study of islet transplantation alone evaluating safety and efficacy in five patients with type 1 diabetes. Islet isolation from deceased donor pancreases will be performed at the Mayo Rochester Islet Isolation facility and islets infused by Interventional Radiology into the portal venous system. Following islet infusion, patients will be hospitalized for 48 hours in the General Clinical Research Center (GCRC) or at the Rochester Methodist Hospital. Multiple safety and efficacy outcomes will be followed on multiple occasions during the first year and periodically thereafter.
Primary Outcome
Hypoglycemia is an abnormally diminished content of glucose in the blood.
Interventions
- BIOLOGICAL Islet Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2006-07 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
Why NCT00437398 stopped before completion
NCT00437398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Islet Transplant is the first listed.
NCT00437398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00437398 about?
NCT00437398 is a clinical study titled "Islet Transplantation for Type 1 Diabetes Mellitus". The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time, associated with an increased risk of severe hypoglycemia and implemented by less than 50 % of the population of such patients. Outcomes of tran...
What is the current status of trial NCT00437398?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2006-07. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00437398?
The interventions under investigation include: Islet Transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT00437398?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00437398's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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