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：
7747950
负责人：
TIMOTHY D HENRY
金额：
$ 40.86万
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 2012-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7747950
关键词：
Acute Acute myocardial infarction Address Adherence Adverse event Age Allogenic Alternative Therapies Anterior Area Arts Attention Autologous Award Basic Science Biopsy Blinded Blood Component Removal Bone Marrow Bone Marrow Stem Cell Bone marrow biopsy CD34 gene Cardiac Cardiac Surgery procedures Cardiology Cardiovascular Diseases Cardiovascular system Caring Catheters Cell Separation Cell Therapy Cell Transplants Cell physiology Cells Center for Translational Science Activities Chronic Disease Clinical Clinical Research Clinical Research Protocols Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Clinical trial protocol document Collaborations Contracts Coronary Artery Bypass County Data Quality Data Reporting Development Devices Disease Progression Economic Inflation Enrollment Ensure Europe Evaluation External Counterpulsation FDA approved Foundations Funding Future Gene Proteins Genes Goals Grant Guidelines Health Heart Heart Transplantation Heart failure Hematopoietic Hematopoietic stem cells Hospitals Image Individual Industry Institutes Institution Intervention Intravenous Ischemia Knowledge Laboratories Left Left Ventricular Dysfunction Left Ventricular Ejection Fraction Left Ventricular Function Life Magnetic Resonance Imaging Measurement Measures Mechanics Medical Medical center Mesenchymal Stem Cells Methods Minnesota Mission Modeling Molecular Mononuclear Morbidity - disease rate Multi-Institutional Clinical Trial Multicenter Trials Myocardial Myocardial Infarction Myocardium National Heart, Lung, and Blood Institute Neurostimulation procedures of spinal cord tissue Obstruction Operative Surgical Procedures Outcome Pacemakers Patient Care Patient Selection Patient Transfer Patients Percutaneous Transluminal Coronary Angioplasty Peripheral Peripheral Blood Stem Cell Phase Phase I Clinical Trials Phase II Clinical Trials Placebos Play Population Population Group Population Study Positioning Attribute Preparation Principal Investigator Procedures Process Production Protocols documentation Quality Control Randomized Recommendation Recording of previous events Refractory Regulation Reperfusion Therapy Reporting Research Research Ethics Committees Research Infrastructure Research Personnel Resources Role Safety Sampling Science Site Site Visit Skeletal Muscle Skeletal Myoblasts Somatic Cell Source Staging Stem cells Structure Surrogate Endpoint Techniques Telephone Therapeutic Therapeutic Studies Therapy Clinical Trials Time Translating Translations Treatment Efficacy U-Series Cooperative Agreements United States United States National Institutes of Health Universities Vision Wisconsin Work abstracting acute coronary syndrome angiogenesis biobank cell type cellular engineering clinical application clinical practice clinical research site clinically relevant data exchange design early experience experience flexibility gene therapy improved innovation meetings member mortality multidisciplinary myogenesis novel patient population peripheral blood placebo controlled study pre-clinical pressure prevent programs quality assurance ranolazine reconstitution repaired repository research and development response responsible research conduct sensor skills stem stop flow technique success symposium therapeutic angiogenesis 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）：明尼苏达心血管细胞治疗临床研究网络 (MnCTN) 非常适合促进针对心血管疾病患者的新型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州分子和细胞治疗公司（属于 NHLBI 资助的细胞治疗生产援助 (PACT) 小组的一部分）组成。 MnCTN 对于 NIH 以及参与该应用的机构的使命至关重要，所有这些都旨在改善患者的健康并拯救生命，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评估细胞疗法的临床研究。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 机构拥有全国公认的专业知识，涉及大量临床患者群体，这些患者的治疗需求未得到满足，并且很可能从细胞治疗中受益（例如急性心肌梗塞、难治性心绞痛和终末期心力衰竭，包括左心室辅助患者）设备）。我们在这些领域的多中心试验中拥有高入组率和高质量数据的出色记录，其中包括 11 项最近完成和/或正在进行的心血管细胞治疗临床试验。我们丰富的经验在试验设计、患者选择、给药技术和终点测量（包括最先进的成像和替代终点）方面积累了专业知识。作为三个 PACT 机构之一，我们拥有独特的优势，促进标准的建立以及良好生产和临床实践在研究过程中的应用。凭借该 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选定进行临床试验的地点的成功率。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基础科学长期成功的基础上。在本次 RFA 的框架下，这种方法将产生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。利用本 RFA 下的临床地点和资源，我们将建立一个骨髓和外周血干细胞储存库，用于识别和表征最合适的细胞，以及未来对治疗的反应者。我们相信，我们非常适合在 NHLBI 心血管细胞治疗研究网络中发挥重要作用，利用我们的基础研究技能、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。（摘要完）