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

描述（由申请人提供）： 明尼苏达州区域心血管细胞治疗临床研究网络（MNCCTRN）非常适合继续其在评估心血管疾病患者新型细胞治疗策略方面的关键作用。MNCCTRN是由明尼苏达州五家尖端心血管机构（明尼苏达大学雅培西北医院明尼阿波利斯心脏研究所、马约诊所、Mercy医院和联合医院）与明尼苏达州分子和细胞治疗公司（NHLBI赞助的细胞治疗生产援助（PACT）小组）和明尼苏达大学心血管修复生物库中心联合组成的联盟。我们建议增加2个有经验的机构，亨内平县医疗中心和明尼阿波利斯退伍军人医疗中心。MNCCTRN已经证明它是NIH的使命的一个至关重要的合作伙伴，所有这些都旨在改善患者的健康和挽救生命，它提供了一个独特的机会，将有前途的细胞治疗基础科学转化为选择有限的患者的新颖和成功的临床替代方案。MNCCTRN拥有全国公认的专业知识，拥有大量临床患者人群，证明了未满足的需求和从细胞治疗中获益的高可能性（例如，急性心肌梗死、难治性心绞痛和终末期心力衰竭，包括左心室辅助装置和外周动脉疾病患者）。我们在这些领域的多中心试验中具有出色的高入组率和高质量数据记录，包括由初始CCTRN资助（HL-06-001）赞助的试验。我们丰富的经验包括在试验设计，交付技术，患者招募和终点测量方面的专业知识，包括最先进的成像，宝贵的生物储存库以及作为PACT五家生产和分销细胞治疗产品的机构之一的独特优势。此外，我们提出了两个临床研究技能发展计划：第一个是临床研究协调员培训的独特建议，第二个是临床研究调查员。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和对心血管疾病影响的临床相关问题。我们非常适合继续为NHLBI心血管细胞治疗研究网络做出重要贡献，利用我们的基本研究技能和无与伦比的能力进行良好的临床试验。

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.