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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00442806
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : November 2007
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: Eric Duckers, MD, PhD Erasmus University Medical Centrum, ThoraxCenter
More Information

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT00442806     History of Changes
Other Study ID Numbers: APOLLO - 01
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013

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
Infarction
Cardiovascular Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
ST Elevation Myocardial Infarction
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Vascular Diseases
Arterial Occlusive Diseases