Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytori Therapeutics

Criteria

Key Inclusion Criteria:

• Acute myocardial infarction (AMI)

• Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin

• Successful revascularization of the culprit lesion in the major epicardial vessel

• Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI

• Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.

• Ability to undergo liposuction

Key Exclusion Criteria:

• Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)

• More than 24 hours after acute PCI

• Significant valvular disease

• More than twelve hours between the onset of first symptoms of AMI and revascularization

• Hemodynamic instability within 24 hours prior to randomization

• Neoplasia

• Acute or chronic bacterial or viral infectious disease

• Pacemaker, ICD or any other contra-indication for MRI

• LVEF <30% or >50% by Left Ventricular Angiography

• Moderate or severe COPD