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NCT00566813 · ClinicalTrials.gov registry record · Phase 1
Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression
A Phase 1 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00566813: Completed Phase 1 study, sponsored by University of Illinois at Chicago.
NCT00566813 is a Phase 1 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00566813, a Phase 1 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The primary purpose of this study is to demonstrate the safety of allogeneic islet transplantation in type 1 diabetic patients performed at the University of Illinois at Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that pancreatic islets isolated at UIC are safe and of sufficient quality to provide reproducible graft function.
Primary Outcome
* Frequency of adverse events including laboratory abnormalities * HbA1C (less than 6.1% is considered normal) * Glucose control and absence of hypoglycemic coma/unawareness, as evidenced by no further requirement for third-party assistance or hospital attendance resulting from a severe hypoglycemic episode * Renal function, measured both by serum creatinine and calculated GFR using the Cockroft \& Gault * Lipid profiles for cholesterol, triglycerides, low density lipoprotein (LDL) and high dens
Interventions
- DRUG Islet Cell Transplant
- DRUG Islet Cell Transplant plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2004-11 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 1 |
What the finished NCT00566813 record still lists
NCT00566813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Islet Cell Transplant is the first listed.
NCT00566813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00566813 about?
NCT00566813 is a clinical study titled "Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression". The primary purpose of this study is to demonstrate the safety of allogeneic islet transplantation in type 1 diabetic patients performed at the University of Illinois at Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that pancreatic islets isolated at UIC are safe an...
What is the current status of trial NCT00566813?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2004-11. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT00566813?
The interventions under investigation include: Islet Cell Transplant (DRUG), Islet Cell Transplant plus (DRUG).
Who is sponsoring clinical trial NCT00566813?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00566813's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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