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

描述(由申请人提供)： 明尼苏达地区心血管细胞治疗临床研究网络(MNCCTRN)非常适合继续在评估心血管疾病患者的新细胞治疗策略方面发挥关键作用。MNCCTRN是由五家尖端的明尼苏达州心血管机构(雅培西北医院的明尼阿波利斯心脏研究所、明尼苏达大学、梅奥诊所、仁慈医院和联合医院)与明尼苏达州分子和细胞治疗(NHLBI赞助的细胞疗法生产援助(PACT)组)和明尼苏达大学心血管修复生物库中心组成的联盟。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使命的一个至关重要的合作伙伴，而参与这一应用的机构都旨在改善患者的健康和拯救生命，S说，它为选择有限的患者提供了一个独特的机会，将前景光明的细胞治疗基础科学转化为新的、成功的临床替代方案。MNCCTRN拥有国家认可的专业知识，拥有大量临床患者群体，显示出未得到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、顽固性心绞痛和终末期心力衰竭，包括使用左心室辅助装置和外周动脉疾病的患者)。我们在这些领域的多中心试验中有着出色的高登记记录和高质量的数据，包括由CCTRN初始赠款(HL-06-001)赞助的试验。我们丰富的经验包括试验设计、给药技术、患者登记和终点测量方面的专业知识，包括最先进的成像技术、无价的生物信息库，以及作为生产和分销细胞治疗产品的五家PACT机构之一的独特优势。此外，我们还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人员的培训。MNCCTRN的目标是产生进一步的科学知识，并解决有关细胞疗法的机制和对心血管疾病的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，充分利用我们的基本研究技能和进行良好执行的临床试验的无与伦比的能力。

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.