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Sponsored by: |
TCA Cellular Therapy |
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Information provided by: | TCA Cellular Therapy |
ClinicalTrials.gov Identifier: | NCT00548613 |
The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. End points will be the assessment of development of mature and stable new blood vessels as well as improvement in cardiac function.
This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the safety and feasibility of use of the proposed combination of autologous stem cells. Potential subjects who fulfill clinical and laboratory entry criteria at screening will undergo a process of bone marrow aspiration for preparation of the two types of bone marrow-derived stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant, patients will be have a 3 month follow-up to evaluate safety as well as functional heart improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.
Study population will include adult male and female subjects, ages 18-70, presenting with acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial infarction and will undergo coronary artery bypass grafting.
Patients will be divided in two groups:
Patients will receive the cell mixture by intracoronary or intramyocardial infusion, respectively.
The rationale of this clinical study is based on the observation that most attempts using adult stem cells for myocardial regeneration have utilized a source of bone marrow derived progenitor cells with the potential to generate new blood vessel and thus contribute to the revascularization of the ischemic tissue. This therapy seems to be adequate but not sufficient, since it lacks a source of stem cells capable of differentiating and maturing into cardiac muscle cells, thus contributing to the recovery of local contractility. The proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at contributing cell types capable of regenerating both blood vessels and muscle tissues damaged after MI.
Condition | Intervention | Phase |
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Coronary Artery Disease Coronary Arteriosclerosis Coronary Atherosclerosis Coronary Disease |
Biological: MESENDO |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study to Determine the Safety and Feasibility of the Use of a Combination Stem Cell Therapy in Patients With Acute Myocardial Infarction |
Estimated Enrollment: | 20 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients with documented acute myocardial infarction (heart attack) occurring within 4-24 hours after onset of symptoms
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Biological: MESENDO
Intracoronary transplantation of autologous stem cells via balloon catheter
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B: Experimental
Candidates for coronary artery bypass grafting that suffered a myocardial infarction (heart attack) within the past 12 months
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Biological: MESENDO
Intracardiac transplantation of autologous stem cells via direct injection
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ARM: A -
Patients with acute myocardial infarction with ST elevation who underwent percutaneous revascularization between 4 and 24 hours after the initiation of symptoms.
Acute myocardial infarction occurring within 4-24 hours after onset of symptoms documented by at least one of the following:
ARM - B
Patients who are candidates for coronary artery bypass grafting surgery according to ACC/AHA guidelines and have had a myocardial infarction in the past 12 months.
Exclusion Criteria:
ARM - A
ARM - B
Contact: Vicki L. Nicely | 985 867-4860 | vicki@tcaway.com |
United States, Louisiana | |
TCA Cellular Therapy, LLC | Recruiting |
Covington, Louisiana, United States, 70433 | |
Contact: Vicki L. Nicely 985-867-4860 vicki@tcaway.com | |
Principal Investigator: Gabriel P. Lasala, M.D. |
Principal Investigator: | Gabriel P. Lasala, M.D. | TCA Cellular Therapy, LLC |
Responsible Party: | TCA Cellular Therapy, LLC ( Gabriel P. Lasala, MD ) |
Study ID Numbers: | 2007-02-I |
Study First Received: | October 22, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00548613 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myocardial Infarction Heart Attack Coronary Artery Bypass Grafting |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Arteriosclerosis Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Myocardial Infarction Coronary Artery Disease |