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Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
SecondaryObjective
The secondary objectives are to explore functional efficacy for subsequent study design, as well as late-term dose related tolerance, by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | 5 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection |
|
| A2 | Other | 5 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. |
|
| B1 | Experimental | 5 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection |
|
| B2 | Other | 3 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. |
|
| C1 | Experimental | 5 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection |
|
| C2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Mesenchymal Precursor Cells (MPCs) | Genetic | 25 M allogeneic MPCs by transendocardial injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Explore efficacy for subsequent study design and dose related tolerance: •Effect related to cardiac function.•Change from baseline in SF-36, KCCQ, SAQ, and the NYHA Classification.•Follow-up safety through Day 360 • Dose selection for future stu | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Subject is hemodynamically unstable at Day 5 post-AMI as demonstrated by any of the following:
Sustained ventricular tachycardia as demonstrated by QRS complexes wider than 120 msec, lasting >30 secs, and >100 bpm occurring >48 hours following PCI without any identifiable, reversible cause (ie, electrolyte imbalance).
Further revascularization planned for the next 30 days.
Chronic atrial fibrillation.
A wall thickness in the target region <8 mm as determined by 2D echocardiography(the target region is defined at the time of NOGA® mapping).
An LV thrombus.
Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV.
Echocardiographic evidence of hypertrophic cardiomyopathy indicating heart muscle thickness >15 mm.
Human immunodeficiency virus (HIV)
Serum glucose level ≥ 400 mg/dl within 24 hours of study procedure
Serum glucose level 300-400 mg/dl and presence of urine ketones within 24 hours of study procedure.
Claustrophobic, or with medical conditions or contradictions that impede performing baseline MRI study.
An active uncontrolled infection.
A prosthetic aortic valve.
Presence of ≥ 20% anti-HLA antibody titers and/or having antibody specificities to donor HLA antigens.
A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
A known hypersensitivity to dimethyl sulfoxide (DMSO), murine and/or bovine products.
Pregnancy or breastfeeding.
Imprisoned at the time of enrollment.
A treatment and/or an uncompleted follow-up treatment of any investigational therapy within 6 months before implantation surgery and intent to participate in any other investigational drug or cell therapy study during the 3-year follow-up period of this study.
Active participation in other research therapy for cardiovascular repair/regeneration.
A prior recipient of stem precursor cell therapy for cardiac repair.
Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Skerrett, MD | Contact | 1-888-369-2123 | donna.skerrett@angioblast.com |
| Name | Affiliation | Role |
|---|---|---|
| Emerson C. Perin, MD, PhD | Texas Heart Institute/St. Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota/Minneapolis Heart Institute | Recruiting | Minneapolis | Minnesota | 55407-1139 | United States |
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| Other |
2 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. |
|
| Standard-of-care treatment with NOGA® mapping and staged injections. | Procedure | Standard-of-care treatment with NOGA® mapping and staged injections. |
|
| Allogeneic Mesenchymal Precursor Cells (MPCs) | Genetic | 75 M allogeneic MPCs by transendocardial injection |
|
| Standard-of-care treatment with NOGA® mapping and staged injections. | Procedure | Standard-of-care treatment with NOGA® mapping and staged injections. |
|
| Allogeneic Mesenchymal Precursor Cells (MPCs) | Genetic | 150 M allogeneic MPCs by transendocardial injection |
|
| Standard-of-care treatment with NOGA® mapping and staged injections. | Procedure | Standard-of-care treatment with NOGA® mapping and staged injections. |
|
| Texas Heart Institute/St. Luke's Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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