Pre-Serve AMI

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.

Pre-Serve AMI [NCT01495364]

Title: 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.

Drug: Bone marrow derived Autologous CD34+ Selected Cell Product; Drug: Placebo 

 

Primary Investigator: Kereiakes

Drug/Device Information
Intra-coronary Infusion of AMR-001, Bone marrow derived Autologous CD34+ Selected Cell Product vs placebo
Amorcyte
Major Inclusion and Exclusion
STEMI with successful stenting
EF ≤ 48
Creatinine ≤ 2.5
Platelet ≥ 100,000
Hgb ≥ 10
No cardiogenic shock
No planned revascularization intervention during the next 6 months (A second PCI can be performed if done prior to qualifying CMR)