Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00265473 · ClinicalTrials.gov registry record · Phase 1
MGA031, Sirolimus and Tacrolimus in Islet Transplantation
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00265473: Completed Phase 1 study, sponsored by University of Minnesota.
NCT00265473 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265473, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This clinical trial is designed to extend the observations made in our pilot clinical trial (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus in preventing rejection and autoimmune destruction of deceased donor pancreatic islet transplants in type 1 diabetic recipients.
Primary Outcome
Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.
Interventions
- BIOLOGICAL Allogeneic Islets of Langerhans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-11 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00265473 record still lists
NCT00265473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Allogeneic Islets of Langerhans is the first listed.
NCT00265473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00265473 about?
NCT00265473 is a clinical study titled "MGA031, Sirolimus and Tacrolimus in Islet Transplantation". This clinical trial is designed to extend the observations made in our pilot clinical trial (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus in preventing rejecti...
What is the current status of trial NCT00265473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2005-11. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00265473?
The interventions under investigation include: Allogeneic Islets of Langerhans (BIOLOGICAL).
Who is sponsoring clinical trial NCT00265473?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00265473's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia