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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 is a Phase 2 study that has completed, run by Lisata Therapeutics. The registered enrollment target is 195 participants.
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.
Interventions
- OTHER placebo
- BIOLOGICAL NBS10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495364
The ClinicalTrials.gov registry entry for NCT01495364 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lisata Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01495364 reports 0 study locations.
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.
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