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

Sponsor:	Cytori Therapeutics
Information provided by:	Cytori Therapeutics
ClinicalTrials.gov Identifier:	NCT00442806

Purpose

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	Intervention	Phase
Myocardial Infarction Coronary Arteriosclerosis Cardiovascular Disease Coronary Disease	Drug: Injection of ADRC's Other: Injection of Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

U.S. FDA Resources

Further study details as provided by Cytori Therapeutics:

Primary Outcome Measures:

Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442806

Locations

Netherlands
Erasmus University Medical Centrum, Thorax Center
Rotterdam, Netherlands
Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007

Sponsors and Collaborators

Cytori Therapeutics

Investigators

Study Director:	Alexander M Milstein, MD	Cytori Therapeutics
Principal Investigator:	Patrick Serruys, MD, PhD	Erasmus University Medical Centrum, Thorax Center

More Information

No publications provided

Responsible Party:	Amanda Lehr, Clinical Program Manager, Cytori Therapeutics
ClinicalTrials.gov Identifier:	NCT00442806 History of Changes
Other Study ID Numbers:	APOLLO - 01
Study First Received:	February 28, 2007
Last Updated:	May 13, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

Keywords provided by Cytori Therapeutics:

ADRC
Stem Cells
Myocardial Infarction
STEMI
Heart Disease
Coronary Artery Disease

Coronary Disease
ST-Elevation
AMI
Interventional Cardiology
Heart Attack

Additional relevant MeSH terms:

Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction

Arterial Occlusive Diseases
Vascular Diseases
Heart Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on February 09, 2012