Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Cytori Therapeutics.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cytori Therapeutics
Information provided by:
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT00442806
First received: February 28, 2007
Last updated: May 13, 2011
Last verified: May 2011
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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 ]
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2011 (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
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
| Study Director: | Alexander M Milstein, MD | Cytori Therapeutics |
| Principal Investigator: | Patrick Serruys, MD, PhD | Erasmus University Medical Centrum, Thorax Center |
More Information
No publications provided
| Responsible Party: | Amanda Lehr, Clinical Program Manager, Cytori Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00442806 History of Changes |
| Other Study ID Numbers: | APOLLO - 01 |
| Study First Received: | February 28, 2007 |
| Last Updated: | May 13, 2011 |
| 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:
|
Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction |
Arterial Occlusive Diseases Vascular Diseases Heart Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 22, 2013