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NCT01576328 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
A Phase 1 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01576328: Completed Phase 1 study, sponsored by Mesoblast.
NCT01576328 is a Phase 1 study that has completed, run by Mesoblast. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576328, a Phase 1 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
Primary Outcome
Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination
Interventions
- DRUG Mesenchymal Precursor Cells (MPCs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT01576328 record still lists
NCT01576328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Mesenchymal Precursor Cells (MPCs) is the first listed.
NCT01576328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01576328 about?
NCT01576328 is a clinical study titled "Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes". This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
What is the current status of trial NCT01576328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2012-04. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01576328?
The interventions under investigation include: Mesenchymal Precursor Cells (MPCs) (DRUG).
Who is sponsoring clinical trial NCT01576328?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01576328's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 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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