Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)

A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study

Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).

This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.

Key Inclusion Criteria:

• ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
• Ischemic symptoms AND
• ECG:
• Development of pathologic Q waves on the ECG; or
• ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or
• New left bundle branch block; AND
• Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal between admission and randomization
• Successful revascularization of the culprit lesion in a major epicardial vessel

Key Exclusion Criteria:

• More than 24 hours between PCI and start of liposuction
• Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
• Pacemaker, ICD, or any other contra-indication for MRI
• Patients with increased bleeding risk
• Cardiogenic shock present post-index PCI