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This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology.
Heart failure subjects recruited will include those who have advanced heart failure NYHA (New York Heart Association) class II to IV and a depressed ejection fraction (EF < 40%). Baseline eligibility testing assessments will be completed within 28 days prior to cell delivery. Efficacy will be explored at 3, 6, and 12 months.
This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive standard-of-care treatment without MPC administration. The fifteen subjects randomized to receive standard of care without needle injection will serve as the study's control population and will undergo mock mapping and verbal injection scripts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator | 15 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection and mapping. |
|
| A2 | Sham Comparator | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
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| B1 | Active Comparator | 15 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection and mapping. |
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| B2 | Sham Comparator | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
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| C1 | Active Comparator | 15 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection and mapping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Precursor Cells (MPCs) | Biological | 25 M allogeneic MPCs by transendocardial injection and mapping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives are to explore functional efficacy for subsequent study design. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerson Perin, MD | Texas Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | United States | ||
| University of California, San Diego |
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| C2 |
| Sham Comparator |
5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
|
| Mesenchymal Precursor Cells (MPCs) | Biological | 75 M allogeneic MPCs by transendocardial injection and mapping. |
|
|
| Mesenchymal Precursor Cells (MPCs) | Biological | 150 M allogeneic MPCs by transendocardial injection |
|
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| standard-of-care treatment with mock mapping and injection procedures. | Procedure | Mock |
|
| standard-of-care treatment with mock mapping and injection procedures. | Procedure | Mock |
|
| standard-of-care treatment with mock mapping and injection procedures. | Procedure | Mock |
|
| La Jolla |
| California |
| 92037-1300 |
| United States |
| Minneapolis Heart Institute 920 East 28th St, Suite 300 | Minneapolis | Minnesota | 55407-1139 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Texas Heart Institue | Houston | Texas | 77030 | United States |
| Swedish Heart and Vascular Institute | Seattle | Washington | 98122 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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