MN Regional Cardiovascular Cell Therapy Clinical Res. Network: From AMI to PAD

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DESCRIPTION (provided by applicant): The Minnesota Regional Cardiovascular Cell Therapy Clinical Research Network (MNCCTRN) is ideally suited to continue its key role in the evaluation of novel cell therapy strategies for individuals with cardiovascular disease. MNCCTRN is a consortium of five cutting-edge Minnesota cardiovascular institutions (Minneapolis Heart Institute at Abbott Northwestern Hospital, University of Minnesota, Mayo Clinic, Mercy Hospital and United Hospital), in conjunction with the Minnesota Molecular and Cellular Therapeutics (NHLBI-sponsored Production Assistance for Cellular Therapies (PACT) group) and the Center for Cardiovascular Repair Biorepository at the University of Minnesota. We propose to add 2 experienced institutions, Hennepin County Medical Center and the Minneapolis VA Medical Center. The MNCCTRN has demonstrated it is a critically important partner to the mission of the NIH, and the institutions in this application, all of which aim to improve patients' health and save lives, s it provides a unique opportunity to translate promising cell therapy basic science into novel and successful clinical alternative for patients with limited options. MNCCTRN have nationally recognized expertise with large clinical patient populations demonstrating unmet need and a high likelihood of benefit from cellular therapy (e.g., acute myocardial infarction, refractory angina, and end-stage heart failure, including patients with left ventricular assist devices and peripheral artery disease). We have an outstanding track record of high enrollment with high quality data in multicenter trials in these areas, including those sponsored by the initial CCTRN grant (HL-06-001). Our extensive experience includes expertise In trial design, delivery techniques, patient enrollment, and endpoint measurements including state-of-the-art imaging, an invaluable biorepository and the distinct advantage of being one of five PACT institutions for manufacture and distribution of cell therapy products. In addition, we propose two clinical research skills development programs: the 1st a unique proposal for clinical research coordinator training and a 2nd for clinical research investigators. The MNCCTRN's goal is to generate further scientific knowledge and address clinically relevant questions on mechanisms of cell therapies and effects on cardiovascular disease. We are ideally suited to continue our critical contribution to the NHLBI cardiovascular cell therapy research network, capitalizing on our basic research skills and unsurpassed ability to conduct well executed clinical trials.