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
  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 1

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:


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 ]

Enrollment: 14
Study Start Date: November 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Principal Investigator: Eric Duckers, MD, PhD Erasmus University Medical Centrum, ThoraxCenter
  More Information

No publications provided

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT00442806     History of Changes
Other Study ID Numbers: APOLLO - 01
Study First Received: February 28, 2007
Last Updated: November 25, 2013
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:
Coronary Disease
Coronary Artery Disease
Cardiovascular Diseases
Infarction
Myocardial Infarction
Arteriosclerosis
Atherosclerosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on September 16, 2014