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

Cytori Therapeutics

Status and phase: Completed; Phase 1

Conditions: Coronary Arteriosclerosis; Myocardial Infarction; Coronary Disease; Cardiovascular Disease

Treatments: Drug: Injection of ADRC's; Other: Injection of Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442806

APOLLO - 01

Details and patient eligibility

About

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.

Full description

Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.

Enrollment: 14 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo is injected

Treatment:

Other: Injection of Placebo

Treatment

Experimental group

Description:

ADRC's are injected

Treatment:

Drug: Injection of ADRC's