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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT00442806
First received: February 28, 2007
Last updated: November 25, 2013
Last verified: November 2013

February 28, 2007
November 25, 2013
November 2007
April 2012   (final data collection date for primary outcome measure)
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Complete list of historical versions of study NCT00442806 on ClinicalTrials.gov Archive Site
Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography
Not Provided
Not Provided
 
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Coronary Arteriosclerosis
  • Cardiovascular Disease
  • Coronary Disease
  • Drug: Injection of ADRC's
    ADRC's are injected
  • Other: Injection of Placebo
    Placebo is injected
  • Placebo Comparator: Placebo
    Placebo is injected
    Intervention: Other: Injection of Placebo
  • Experimental: Treatment
    ADRC's are injected
    Intervention: Drug: Injection of ADRC's
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Spain
 
NCT00442806
APOLLO - 01
Yes
Cytori Therapeutics
Cytori Therapeutics
Not Provided
Principal Investigator: Eric Duckers, MD, PhD Erasmus University Medical Centrum, ThoraxCenter
Cytori Therapeutics
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP