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Completed

NCT Number: NCT00442806

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Erasmus University Medical Centrum, Thorax Center, Rotterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of ADRC's

Drug

ADRC's are injected

Injection of placebo

Other

Placebo is injected

Primary outcomes

  1. Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)

    Time frame: 6 months

Secondary outcomes

  1. Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Cytori Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2007
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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