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NCT01495364 · ClinicalTrials.gov registry record · Phase 2
NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction
A Phase 2 study, sponsored by Lisata Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT01495364: Completed Phase 2 study, sponsored by Lisata Therapeutics.
NCT01495364 is a Phase 2 study that has completed, run by Lisata Therapeutics. The registered enrollment target is 195 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495364, a Phase 2 study, has completed, sponsored by Lisata Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI in addition to other endpoints.
Primary Outcome
The primary endpoint includes the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE) and the assessment of myocardial perfusion measured by quantitative gated SPECT MPI specifically looking at resting total severity score.
Interventions
- OTHER placebo
- BIOLOGICAL NBS10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01495364 record still lists
NCT01495364 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01495364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01495364 about?
NCT01495364 is a clinical study titled "NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction". This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control...
What is the current status of trial NCT01495364?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2011-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01495364?
The interventions under investigation include: placebo (OTHER), NBS10 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01495364?
This trial is sponsored by Lisata Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495364's enrollment target sits among peer trials
195 350th of 2000 higher than 1,649 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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