REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts

Study Overview
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Brief Summary
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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.

Conditions
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Ischemic Cardiomyopathy, Chronic Ischemic Cardiomyopathy

Intervention / Treatment
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* Biological: Endomyocardial injections of allogeneic Human CSps
* Biological: Endomyocardial injections of vehicle only.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo control<br> | Biological: Endomyocardial injections of vehicle only.<br>* NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.<br>|
| Experimental: Group: Cardiosphere Treatment<br>Biological: Allogeneic Human Cardiospheres (allogeneic CSps or alloCSps), a 3D micro-tissue heart-derived cell therapy product. Subjects will receive 150 million cell-equivalents of alloCSps via endomyocardial injection (10 million per site at 15 peri-infarct sites) | Biological: Endomyocardial injections of allogeneic Human CSps<br>* NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.<br>* Other names: Biological: Allogeneic Human CSps (or alloCSps);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Disease, Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Cardiovascular Disease, Chronic Ischemia