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Sponsors and Collaborators: |
Cedars-Sinai Medical Center National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) Johns Hopkins University The EMMES Corporation |
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Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00893360 |
The purpose of this study is to determine whether giving cardiosphere-derived stem cells (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the heart. Giving a patient their own CDCs is an investigational procedure that has been approved by the Food and Drug Administration for this study. In addition to determining whether this treatment is safe, the study will also examine whether it can decrease the amount of heart muscle damage and/or improve heart function after a heart attack. The amount of heart muscle damage and the function of the heart directly affects prognosis (the predicted course of the disease), and the development of heart failure and other complications some patients experience after a heart attack.
By way of background, scientists and physicians believed, until just a few years ago, that heart muscle damaged after a heart attack could not be replaced. Recently, however, scientists discovered that new heart muscle can form, or be regenerated, and that this process can be enhanced (or increased) by the administration of large numbers of certain cells isolated from the heart or bone marrow. These cells can be stem cells, or cells derived from stem cells, and they may achieve their benefit by forming new heart muscle cells, becoming heart muscle cells themselves, or releasing substances which increase the ability of already existing stem cells to form new heart muscle. All of the studies conducted so far have been experimental and no cell type is approved for routine clinical care of patients with heart disease. However, studies involving bone marrow stem cells do indicate some small improvement in heart function and one large study demonstrated a decrease in clinical events in the group which received bone marrow cells.
Investigators of this study decided to study CDCs because they come from a person's own body, and therefore have no foreign immune antigens which may be rejected. Since the cells come from the person's heart, they are more likely to form heart tissue. In addition, animal studies indicate no safety problems and that these cells are capable of forming heart muscle and blood vessel cells after heart attacks. The investigators are now studying whether the same is true in humans.
Condition | Intervention | Phase |
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Myocardial Infarction Ventricular Dysfunction Congestive Heart Failure Heart Failure |
Other: Control Group Biological: Autologous stem cell infusion |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Phase I Randomized, Dose Escalation Study of the Safety and Efficacy of Intracoronary Delivery of Cardiosphere-Derived Stem Cells in Patients With Ischemic Left Ventricular Dysfunction and a Recent Myocardial Infarction |
Estimated Enrollment: | 30 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Usual Medical Management after Myocardial Infarction: No Intervention |
Other: Control Group
Observation of myocardial recovery after usual medical management
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Cardiac Stem Cell Treatment - Group 1: Experimental |
Biological: Autologous stem cell infusion
Subjects will receive 12.5 million of autologous (grown from your own heart muscle specimen) cardiosphere-derived stem cells via intracoronary delivery.
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Cardiac Stem Cell Treatment -Group 2: Experimental |
Biological: Autologous stem cell infusion
Subjects will receive 25 million of autologous (grown from your own heart muscle specimen) cardiosphere-derived stem cells via intracoronary delivery.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Myocardial infarction due to coronary artery atherosclerotic disease. Myocardial infarction will be defined by a rise in serum troponin I to greater than the 99th percentile of the upper limits of normal with at least one of the following:
Exclusion Criteria:
Contraindications to MRI, including:
Contact: Cynthia Leathers, RN, MSA | (310) 423-3300 | leathersc@cshs.org |
Contact: Michelle Domingo | (310) 423-3875 | domingom@cshs.org |
United States, California | |
Cedars-Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Cynthia Leathers, RN, MSA 310-423-3300 | |
Contact: Michelle Domingo (310) 423-3875 domingom@cshs.org | |
Principal Investigator: Raj Makkar, MD | |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287-6568 | |
Contact: Elayne Breton, RN 410-955-1160 ebreton1@jhmi.edu | |
Principal Investigator: Gary Gerstenblith, MD |
Principal Investigator: | Eduardo Marban, MD, PhD | The Heart Institute, Cedars-Sinai Medical Center |
Responsible Party: | The Heart Institute, Cedars-Sinai Medical Center ( Eduardo Marban MD, PhD ) |
Study ID Numbers: | IND 13930 |
Study First Received: | May 5, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00893360 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Adult Stem cells Cardiosphere derived stem cells Myocardial infarction Congestive heart failure Ventricular dysfunction |
Ventricular Dysfunction Necrosis Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Ventricular Dysfunction, Left Ischemia Infarction Myocardial Infarction |
Ventricular Dysfunction Necrosis Heart Failure Pathologic Processes Heart Diseases Myocardial Ischemia |
Vascular Diseases Ventricular Dysfunction, Left Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |