patients with ST-elevation myocardial infarction
Conditions
Interventions
Product Name: adipose-derived regenerative cells
Product Code: ADRCs
Pharmaceutical Form:
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intracardi
Sponsors
Cytori Therapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Able to provide informed consent 2.Males or females 20 to 85 years of age, inclusive 3·Clinical symptoms consistent with AMI (pain, etc.) for a minimum of 2 and a maximum of 12 hours from onset of symptoms to PCI, and unresponsive to nitroglycerin 4·AMI 5·Anterior AMI: ·= 0.2 mV ST elevation in 2 or more V1 – V6 leads AND interval complaints and first contact =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1·Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF) 2·More than 24 hours after acute PCI 3·Significant valvular disease 4·More than 12 or less than 2 hours between the onset of first symptoms of AMI and revascularization, defined as restoration of at least TIMI 3 flow 5·Inability to complete ADRC infusion within 24 hours of PCI 6·Staged treatment of coronary artery disease, or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI or CABG) planned or scheduled within 6 months after the study procedure 7·Need for mechanical ventilation 8·Cardiogenic shock 9·Hemodynamic instability within 24 hours prior to randomization, defined as the presence of any of the following: 10·Need for inotropic support 11·Systolic blood pressure 100 bpm for more than 1 hour 13·Prior ventricular fibrillation or sustained ventricular tachycardia 14·Persistent atrial fibrillation 15·Neoplasia 16·Acute or chronic bacterial or viral infectious disease 17·Pacemaker, ICD or any other contra-indication for MRI 18·LVEF 50% as determined by left ventriculogram at the time of primary PCI 19·Moderate or severe COPD (refer to Appendix 16 for classification codes) 20·Pregnant and/or nursing females 21.Known relevant allergies or sensitivities 22·Serum creatinine >2.0 mg/dL 23·Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this study 24·Life expectancy <1 year 25·Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and feasibility of adipose-derived stem cells delivered via the intracoronary (IC) route in the treatment of patients with ST-elevation myocardial infarction (STEMI) at 6 months;Secondary Objective: Additional assessments of left ventricular function will be performed at 12, 18, 24, and 36 months after the procedure.;Primary end point(s): Safety endpoints will be assessed at 30 days, and at 3, 6, 12, 18, 24, and 36 months post procedure: ·Major adverse cardiac or cerebral event (MACCE) rates ·Serious adverse events (SAEs) / adverse events (AEs) rates ·Composite clinical endpoint: death, MI, stroke ·Re-hospitalization for heart failure ·Angina pectoris as defined by Canadian Cardiovascular Society (CCS) & Braunwrad Classifications ·New York Heart Association (NYHA) Class ·Continuous Electrocardiographic monitoring for 6 days following procedure (72 hours by telemetry and 72 hours by Holter monitor), then weekly for the first four weeks (for 48 hours) and at 2 , 3, 4 , 6, 12, 18, 24 and 36 months (for 24 hours). Feasibility endpoints will be assessed at the time points specified in Appendix 17 and include the following: ·Absolute LVEF and change in LVEF from baseline to six months (by 2D & 3D echocardiography, LV angiography and MRI 17-segment AHA model) ·MI size (by delayed enhancement in MRI 17-segment AHA model) ·Regional wall thickness and thickening in all segments including infarct area (by MRI 17-segment AHA model)31 ·LV-ESV and LV-EDV (by MRI 17-segment AHA model) ·Absolute and change in perfusion defect after revascularization to six months (by SPECT imaging) ·Wall Motion Score Index (by 2-D echocardiography). | — |
Countries
Netherlands, Spain
Outcome results
None listed