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Myocardial Regeneration Using Cardiac Stem Cells - NCT00474461-40202(Clinical Trial 170006)



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City:  Louisville
State:  
KY
Zip Code: 40202
Conditions: Coronary Artery Disease - Congestive Heart Failure
Purpose: The purpose of this study is to investigate the safety of intracoronary cardiac stem cells therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack. The central hypothesis to be tested is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types. According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement in contractile function and clinical status.
Study summary: This will be an open-label study involving 20 patients and 20-40 controls. This study will be done as a collaborative project between New York Medical College and The University of Louisville. * This study will be a phase I trial assessing the safety and feasibility of intracoronary autologous CSC (harvested from the RAA) transplantation in patients with ICM. We also hope to demonstrate efficacy, but this will be the specific aim of future phase I and II trials. - All patients who are undergoing on-pump CABG will be screened twice. The initial screening will be done to determine the preliminary eligibility (before-CABG screening) of patients for the study. If the patients satisfy the preliminary eligibility criteria stated above, RAA resection (which is performed as routine clinical practice during on-pump CABG) will be performed and the RAA collected, cut and frozen in the operating room, then cultured and expanded into CSCs in vitro. The second screening will occur an average of 4 ± 1 months after CABG surgery, and will utilize a LVEF of < 40% assessed by cardiac MRI and/or the disk summation method [or Simpson's method] using 2-D echocardiography, for final enrollment. - The preliminary eligibility criteria will utilize an EF < 40% measured any of the following cardiac imaging tests performed within 2 weeks prior to screening: echocardiography, and/or gated SPECT and/or LV angiography. - A maximum of 60 patients who satisfy the preliminary eligibility criteria will be enrolled in the preliminary phase of the study (i.e., will have RAA tissue harvested/cultured/expanded). Of these 60 patients, a maximum of 20 will be enrolled in the final phase of the study (i.e., will undergo CSC injections and subsequent follow-up). - In this open-label study, a maximum of 20 patients will eventually receive intracoronary CSC transplantation. These patients will have nonviable myocardium/scar from prior MI and will undergo CABG for ICM. Eligible patients who decline to receive the study treatment (intracoronary CSC injections) but agree and consent to have follow ups through phone calls and medical records review may serve as controls (any additional needed controls will be matched historical control patients. The number of control patients in the study will be 20-40 patients. - Patients who satisfy the preliminary eligibility criteria will be enrolled and revascularized within few days (< 2 weeks) of enrollment. - Patients will receive venous and arterial grafts as needed during CABG surgery. Nonviable myocardial segments will also be revascularized in order to enable subsequent intracoronary delivery of CSCs into the scarred region. - During on-pump CABG surgery, patients will undergo resection of part of the RAA at the cannulation site (this is done routinely during CABG surgery). Resected RAA tissue (< 1 g) will be collected intra-operatively and handled as described in the preparation section. - Cardiac catheterization (coronary angiography) for intracoronary injection of CSCs will be performed 4 ± 1 month after CABG surgery. Worldwide, more than 200 patients have received intracoronary infusions of stem cells (derived from the bone marrow and peripheral blood). None of these patients have had any adverse events as a result of these infusions. The overall objective of this project is to determine whether intracoronary delivery of CSCs can regenerate non-viable myocardial segments in patients with ICM. CSCs will be harvested from right atrial appendages (RAAs) of patients with ICM during surgical revascularization, cultured and expanded in vitro, and then transplanted back into the same patient. The specific aims are: 1. To determine the feasibility of harvesting CSCs from RAAs of patients undergoing surgical revascularization, culturing and expanding them in vitro, and injecting them into patients via the intracoronary route. 2. To determine the safety of intracoronary infusion of CSCs In addition to these safety data, we hope to obtain initial evidence that CSC administration results in clinical improvement.
Criteria: Inclusion Criteria: - LVEF < 40% (by any imaging modality: echocardiography/SPECT/LV angiography) - A history of Q-wave MI with a residual akinetic and nonviable scar (as evidenced by low-dose dobutamine stress echocardiogram and/or or thallium redistribution nuclear study for viability and/or an electrocardiogram) - Patients scheduled for surgical revascularization within few days (< 2 weeks) of the initial screening. Exclusion Criteria: - Cardiogenic shock - Severe co-morbidities (e.g., renal failure, liver failure) - Mini-CABG procedures - Pregnant/nursing women or women of child-bearing potential - History of myocardial infarction within the past month - Inability to provide informed consent - Diabetic
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Data Source: ClinicalTrials.gov
Date Processed: February 16, 2010
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