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NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction

NCT01495364 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2016-04-28

No results posted yet for this 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.

Conditions

  • ST Segment Elevation Myocardial Infarction

Interventions

BIOLOGICAL

NBS10

dosage = 10 or more million CD34+ cells via intracoronary infusion

OTHER

placebo

matching placebo

Sponsors & Collaborators

  • Lisata Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Moss, MD · Lisata Therapeutics, Inc.

  • Arshed Quyyumi, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-06-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495364 on ClinicalTrials.gov