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MN Cardiovascular Cell Therapy Clinical Research Network: From AMI to CHF

明尼苏达心血管细胞治疗临床研究网络：从 AMI 到 CHF

基本信息

批准号：
7558564
负责人：
TIMOTHY D HENRY
金额：
$ 42.63万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-01-01 至 2011-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7558564
关键词：
Acute Acute myocardial infarction Address Age Allogenic Anterior Area Arts Attention Autologous Basic Science Blinded Bone Marrow Bone Marrow Stem Cell Cardiac Cardiovascular Diseases Cardiovascular system Catheters Cell Therapy Cells Clinical Clinical Research Clinical Trials Clinical Trials Design Clinical trial protocol document Data Quality Development Disease Progression Economic Inflation Enrollment Europe Evaluation Future Health Heart failure Image Individual Institutes Institution Intervention Ischemia Knowledge Left Left Ventricular Dysfunction Left Ventricular Ejection Fraction Left Ventricular Function Life Magnetic Resonance Imaging Measurement Measures Mesenchymal Stem Cells Methods Minnesota Mission Molecular Mononuclear Multi-Institutional Clinical Trial Multicenter Trials Myocardium National Heart, Lung, and Blood Institute Obstruction Outcome Patient Selection Patients Percutaneous Transluminal Coronary Angioplasty Peripheral Blood Stem Cell Placebos Play Population Study Process Production Protocols documentation Randomized Recording of previous events Refractory Reperfusion Therapy Research Research Infrastructure Resources Role Safety Sampling Site Staging Stem cells Structure Surrogate Endpoint Techniques Therapeutic Therapeutic Studies Therapy Clinical Trials Translating Treatment Efficacy United States National Institutes of Health abstracting biobank clinical application clinical practice clinical research site clinically relevant design experience improved innovation novel patient population peripheral blood placebo controlled study prevent repaired repository response skills stem stop flow technique success ventricular assist device

项目摘要

DESCRIPTION (provided by applicant): The Minnesota Cardiovascular Cell Therapy Clinical Research Network (MnCTN) is ideally suited to promote the evaluation of novel cell therapy strategies for individuals with cardiovascular disease. MnCTN will consist of the consortium of four Minneapolis cutting-edge cardiovascular institutions and the Minnesota Molecular and Cellular Therapeutics (part of the NHLBI-sponsored Production Assistance for Cellular Therapies (PACT) group). The MnCTN is critically important to the mission of the NIH, and the institutions in this application, all of which aim to improve patients' health and save lives, as it provides a unique opportunity to translate basic science of cell therapies into clinical research evaluating the potential of cell therapies as an alternative strategy to halt cardiovascular disease progression and improve patients' outcomes. The institutions of MnCTN have nationally recognized expertise with large clinical patient populations that have unmet treatment 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). We have an outstanding track record of high enrollment and high quality data in multicenter trials in these areas, including 11 recently completed and/or ongoing cardiovascular cellular therapy clinical trials. Our extensive experience has built expertise in trial design, patient selection, delivery techniques, and endpoint measurements including state-of-the-art imaging and surrogate endpoints. We have the distinct advantage of being one of three PACT institutions, which promotes establishment of standards and application of good manufacturing and clinical practices to the research process. With the infrastructure under this RFA, our expertise will greatly enhance the success of cell therapy protocols at other sites selected to carry out clinical trials. The clinical application of cellular therapies is built on a longstanding success of basic science at the UMN Center for Cardiovascular Repair and the Stem Cell Institute. Such approach, under the structure of this RFA, will generate scientific knowledge and address clinically relevant questions on mechanisms of cell therapies and effects on cardiovascular disease. Using the clinical sites and resources under this RFA, we will establish a bone marrow and peripheral blood stem cell repository, which will be used to identify and characterize the best suitable cells, as well as the future responders to therapy. We believe we are perfectly suited to play an important role in the NHLBI cardiovascular cell therapy research network, capitalizing on our basic research skills, abilities to conduct multi-center clinical trials within an integrative network, and to disseminate knowledge. (End of Abstract)

描述（由申请人提供）：