Chronic Ischemic Cardiomyopathy, Ischemic Cardiomyopathy
Conditions
Keywords
Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Disease, Cardiovascular Disease, Chronic Ischemia
Brief summary
A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.
Interventions
BIOLOGICALEndomyocardial injections of allogeneic Human CSps
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.
BIOLOGICALEndomyocardial injections of vehicle only.
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with ischemic cardiomyopathy (EF \>10 and \<40% by functional imaging \[ECHO, CT, MRI, contrast ventriculography\]) * Symptomatic heart failure of NYHA Class 2 or 3 * History of prior remote (\>3 mo) myocardial infarction and/or documented obstructive coronary artery disease with corresponding dysfunctional segments by functional imaging * Age \> 18 years * Ability to provide informed consent and follow-up with protocol procedures
Exclusion criteria
* Documented myocardial infarction within 3 months (120 days) * Known or suspected left ventricular thrombus * Non-cardiovascular disease with life expectancy of \< 3 years * Absence of significant gadolinium-enhanced scar (\>10% of LV mass) at baseline MRIc * Positive panel-reactive antibodies (PRA) * Need for further revascularization clinically indicated at the time the patient is assessed for participation in the clinical trial. This will be determined by a cardiologist who is not an investigator in the clinical trial. No further revascularization may be indicated by no arteries with significant stenosis, the location, and extent of any stenosis may not be suitable for angioplasty, the distal vessels may not be suitable for placement of bypass grafts, and/or the patient declines angioplasty or bypass surgery. * NYHA IV heart failure * History of aortic stenosis/insufficiency * Requirement for chronic immunosuppressive therapy * Participation in an on-going protocol studying an experimental drug or device * Diagnosis of congenital or genetically-transmitted cardiomyopathy * Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures * Pregnancy or child-bearing potential without use of effective contraception. Men intending to father children are also excluded. * Human Immunodeficiency virus infection * Viral hepatitis * Uncontrolled diabetes and/or hemoglobin A1C \> 8.5% * Abnormal liver function (SGPT \> 3 times the upper reference range) and/or hematology (hematocrit \<25%, WBC \<3000, Platelets \<100,000) studies without a reversible, identifiable cause * Ventricular tachycardia or fibrillation not associated with an acute ischemic episode * Canadian Cardiovascular Society Angina Class 3 or 4 * History of cardiac tumor or cardiac tumor demonstrated or suspected on MRI other imaging modality * Previous stem cell therapy/treatment * Individuals who are not fluent in English
Countries
United States
Outcome results
None listed