Clinical trial NCT00442806: Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myocardial Infarction
Coronary Arteriosclerosis
Cardiovascular Disease
Coronary Disease
Keywords: ADRC
Stem Cells
Myocardial Infarction
STEMI
Heart Disease
Coronary Artery Disease
Coronary Disease
ST-Elevation
AMI
Interventional Cardiology
Heart Attack
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography
timeFrame: 6 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centrum, Thorax Center
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
Study officials:
affiliation: Erasmus University Medical Centrum, ThoraxCenter
name: Eric Duckers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: