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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo control | Sham Comparator |
| |
| Group: Cardiosphere Treatment | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endomyocardial injections of allogeneic Human CSps | Biological | NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Marban, MD, PhD | Cedars-Sinai Medical Center, Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D007238 | Infarction |
| D009203 | Myocardial Infarction |
| D018487 | Ventricular Dysfunction, Left |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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|
| Endomyocardial injections of vehicle only. | Biological | NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo. |
|
| D017202 |
| Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |