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

Sponsor

Cytori Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00442806

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Coronary Arteriosclerosis Cardiovascular Disease Coronary Disease	Drug: Injection of ADRC's Other: Injection of Placebo	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo is injected	Other: Injection of Placebo Placebo is injected
Experimental: Treatment ADRC's are injected	Drug: Injection of ADRC's ADRC's are injected

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo is injected

Other: Injection of Placebo

Placebo is injected

Experimental: Treatment

ADRC's are injected

Drug: Injection of ADRC's

ADRC's are injected

Outcome Measures

Primary Outcome Measures

Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [6 months]

Secondary Outcome Measures

Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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