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

Trial ID or NCT#

NCT01495364

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Prospective Randomized Double Blind Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients With Acute Myocardial Infarction.

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Joseph  C. Wu, MD, PhD
Joseph C. Wu, MD, PhD
Cardiologist
Director, Stanford Cardiovascular Institute, Simon H. Stertzer, MD, Professor and Professor of Radiology

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Contact

Tom Moss, MD
818-903-4036