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Sponsored by: |
Angioblast Systems |
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Information provided by: | Angioblast Systems |
ClinicalTrials.gov Identifier: | NCT00555828 |
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:
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs) Procedure: Standard-of-care treatment with NOGA® mapping and staged injections. |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1b/2a Dose Escalation Study to Assess the Safety and Feasibility of Transendocardial Delivery of 3 Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction |
Estimated Enrollment: | 25 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Experimental
5 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection
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Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs)
25 M allogeneic MPCs by transendocardial injection
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A2
5 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
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Procedure: Standard-of-care treatment with NOGA® mapping and staged injections.
Standard-of-care treatment with NOGA® mapping and staged injections.
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B1: Experimental
5 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection
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Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs)
75 M allogeneic MPCs by transendocardial injection
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B2
3 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
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Procedure: Standard-of-care treatment with NOGA® mapping and staged injections.
Standard-of-care treatment with NOGA® mapping and staged injections.
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C1: Experimental
5 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection
|
Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs)
150 M allogeneic MPCs by transendocardial injection
|
C2
2 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
|
Procedure: Standard-of-care treatment with NOGA® mapping and staged injections.
Standard-of-care treatment with NOGA® mapping and staged injections.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject is hemodynamically unstable at Day 5 post-AMI as demonstrated by any of the following:
Contact: Donna Skerrett, MD | 1-888-369-2123 | donna.skerrett@angioblast.com |
United States, Minnesota | |
University of Minnesota/Minneapolis Heart Institute | Recruiting |
Minneapolis, Minnesota, United States, 55407-1139 | |
Principal Investigator: Timothy D. Henry, MD | |
United States, Texas | |
Texas Heart Institute/St. Luke's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Emerson C. Perin, MD, PhD |
Principal Investigator: | Emerson C. Perin, MD, PhD | Texas Heart Institute/St. Luke's Hospital |
Responsible Party: | Angioblast Systems ( Donna Skerrett, MD ; Medical Director ) |
Study ID Numbers: | EMT-AB001 |
Study First Received: | November 7, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00555828 |
Health Authority: | United States: Food and Drug Administration |
Myocardial Infarction Myocardial infarct Infarction |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |