Cardiovascular Disease, Coronary Arteriosclerosis, Coronary Disease, Myocardial Infarction
Conditions
Keywords
ADRC, Stem Cells, Myocardial Infarction, STEMI, Heart Disease, Coronary Artery Disease, Coronary Disease, ST-Elevation, AMI, Interventional Cardiology, Heart Attack
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.
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.
Interventions
DRUGInjection of ADRC's
ADRC's are injected
OTHERInjection of Placebo
Placebo is injected
Sponsors
Cytori Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography | 6 months |
Countries
Netherlands, Spain
Outcome results
None listed