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

明尼苏达地区心血管细胞治疗临床研究。

基本信息

批准号：
8628864
负责人：
TIMOTHY D HENRY
金额：
$ 79.98万
依托单位：
ALLINA HEALTH SYSTEM
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 2019-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8628864
关键词：
Achievement Acute myocardial infarction Address Area Basic Science Blood Vessels Bone Marrow Cardiac Cardiovascular Diseases Cardiovascular system Cell Therapy Cell physiology Cells Chest Pain Clinic Clinical Clinical Research Clinical Trials Clinical Trials Design Clinical trial protocol document Communities Coronary Coronary sinus structure County Data Quality Development Effectiveness Enrollment Evaluation Extracellular Matrix Goals Grant Health Heart Heart Transplantation Heart failure Hospitals Image Individual Institutes Institution Intramuscular Intravenous Ischemia Knowledge Leadership Left Measurement Medical center Minnesota Mission Modality Molecular Mononuclear Multicenter Trials Myocardial Myocardial Ischemia National Heart, Lung, and Blood Institute Patients Performance Peripheral arterial disease Phase Phase I Clinical Trials Physiology Production Program Development Progress Reports Public Health Refractory Research Research Infrastructure Research Personnel Role Safety Sampling Site Staging Surrogate Endpoint Syndrome Techniques Therapeutic Therapeutic Studies Training Translating Translational Research Translations United States United States National Institutes of Health Universities University Hospitals base biobank cell type cellular targeting clinically relevant experience improved innovation member novel patient population peripheral blood programs repaired response skills success ventricular assist device

项目摘要

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.

描述（由申请人提供）：明尼苏达州区域心血管细胞疗法临床研究网络（MNCCTRN）非常适合继续其在评估心血管疾病患者的新型细胞疗法策略中的关键作用。 MNCCTRN是由五个尖端明尼苏达州心血管机构组成的联盟（明尼苏达州雅培医院的明尼阿波利斯心脏研究所，明尼苏达州大学，梅奥诊所，梅西医院和联合医院），与明尼苏达州分子和细胞的生产疗法（NHLBI）的生产援助（NHLBI）相结合明尼苏达大学的心血管维修生物座位。我们建议添加2个经验丰富的机构，Hennepin County Medical Center和Minneapolis VA医疗中心。 MNCCTRN表明，这是NIH任务的至关重要的合作伙伴，以及本应用程序中的机构，所有这些旨在改善患者的健康并挽救生命，S it提供了一个独特的机会，可以将有希望的细胞疗法基础科学转化为新颖的临床替代方案，可为患者提供有限选择的患者。 MNCCTRN具有全国认可的专业知识，具有较大的临床患者人群，表现出未满足的需求，并且受益于细胞疗法的可能性很大（例如，急性心肌梗死，难治性心绞痛和终阶段心力衰竭，包括患有左心室辅助设备和外围动脉疾病的患者）。在这些领域的多中心试验中，我们在高质量数据中拥有高质量数据的出色记录，包括最初的CCTRN Grant（HL-06-001）赞助的领域。我们丰富的经验包括试验设计，交付技术，患者入学率和终点测量方面的专业知识，包括最先进的成像，宝贵的生物措施以及成为生产和分布细胞治疗产品的五个协定机构之一。此外，我们提出了两个临床研究技能开发计划：第一个针对临床研究协调员培训的独特提案，以及临床研究研究人员的第二个。 MNCCTRN的目标是产生进一步的科学知识，并解决有关细胞疗法机制以及对心血管疾病的影响的临床相关问题。理想情况下，我们非常适合继续对NHLBI心血管细胞疗法研究网络的关键贡献，利用我们的基础研究技能以及无与伦比的进行良好执行临床试验的能力。