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

描述(由申请人提供)： 明尼苏达州心血管细胞治疗临床研究网络(MnCTN)非常适合于促进对心血管疾病患者的新细胞治疗策略的评估。MnCTN将由四家明尼阿波利斯尖端心血管机构和明尼苏达分子和细胞治疗公司(NHLBI赞助的细胞疗法生产援助(PACT)小组的一部分)组成。MnCTN对于NIH的使命和这一应用中的机构至关重要，所有这些机构都旨在改善患者的健康和拯救生命，因为它提供了一个独特的机会，将细胞疗法的基础科学转化为临床研究，评估细胞疗法作为阻止心血管疾病进展和改善患者预后的替代策略的潜力。MnCTN的机构拥有国家认可的专业知识，拥有大量临床患者群体，这些患者的治疗需求未得到满足，而且从细胞治疗中受益的可能性很高(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的患者)。我们在这些领域的多中心试验中拥有出色的高登记和高质量数据记录，包括11项最近完成和/或正在进行的心血管细胞治疗临床试验。我们丰富的经验积累了试验设计、患者选择、交付技术和终点测量方面的专业知识，包括最先进的成像和替代终点。我们有一个明显的优势，那就是我们是三个PACT机构之一，它促进建立标准，并将良好的制造和临床实践应用到研究过程中。有了这个RFA下的基础设施，我们的专业知识将极大地提高细胞治疗方案在其他被选择进行临床试验的地点的成功。细胞疗法的临床应用建立在UMN心血管修复中心和干细胞研究所长期成功的基础科学基础上。这种方法，在这种RFA的结构下，将产生科学知识，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。利用RFA下的临床站点和资源，我们将建立一个骨髓和外周血干细胞库，用于识别和鉴定最合适的细胞，以及未来的治疗应答者。我们相信，我们完全适合在NHLBI心血管细胞治疗研究网络中发挥重要作用，充分利用我们的基本研究技能、在综合网络中进行多中心临床试验的能力，以及传播知识的能力。(摘要结束)

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)