NCT01495364

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Lisata Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36 months.

Conditions

• ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	NBS10	dosage = 10 or more million CD34+ cells via intracoronary infusion
OTHER	placebo	matching placebo

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-06-01
• Completion: 2016-04-01
• First posted: 2011-12-20
• Last updated: 2016-04-28

Locations

58 sites across 1 country: United States