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：
8215444
负责人：
TIMOTHY D HENRY
金额：
$ 35.42万
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/8215444
关键词：
Acute Acute myocardial infarction Address Adherence Adverse event Age Allogenic Alternative Therapies Anterior Area 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 Goals Grant Guidelines Health Heart Heart Transplantation Heart failure Hematopoietic Hematopoietic stem cells Hospitals Image Individual Industry Institutes Institution Institutional Review Boards Intervention Intravenous Ischemia Knowledge Laboratories Left Left Ventricular Dysfunction Left Ventricular Ejection Fraction Left Ventricular Function 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 Principal Investigator Procedures Process Production Protocols documentation Quality Control Randomized Recommendation Recording of previous events Refractory Regulation Reperfusion Therapy Reporting Research 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 preparation 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）：明尼苏达州心血管细胞疗法临床研究网络（MNCTN）非常适合促进心血管疾病患者的新型细胞疗法策略的评估。 MNCTN将由四个明尼阿波利斯尖端的心血管机构以及明尼苏达州分子和细胞疗法（NHLBI赞助的细胞疗法生产辅助（PACT）组的一部分）组成。 MNCTN对NIH的任务至关重要，并且在本应用中的机构中，所有这些机构旨在改善患者的健康并挽救生命，因为它提供了将细胞疗法的基础科学转化为临床研究的独特机会，以评估细胞疗法作为停止心血管疾病疾病进展的替代策略的潜力，以改善患者的进展。 MNCTN的机构具有全国认可的专业知识，具有较大的临床患者人群，具有未满足的治疗需求，并且受益于细胞疗法的可能性很大（例如，急性心肌梗死，难治性心绞痛和终末期心脏衰竭，包括左心室辅助设备的患者）。在这些领域的多中心试验中，我们拥有高级入学率和高质量数据的出色记录，其中包括最近完成的11个和/或正在进行的心血管细胞疗法临床试验。我们丰富的经验在试验设计，患者选择，交付技术和端点测量方面建立了专业知识，包括最先进的成像和替代端点。我们具有成为三个协议机构之一的明显优势，该机构促进了标准的建立以及良好的制造和临床实践在研究过程中的应用。在此RFA下的基础设施下，我们的专业知识将大大增强在选择进行临床试验的其他地点的细胞治疗方案的成功。细胞疗法的临床应用是建立在UMN心血管修复中心和干细胞研究所的基础科学长期成功的基础上的。在这种RFA的结构下，这种方法将产生科学知识，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。使用此RFA下的临床部位和资源，我们将建立一个骨髓和外周血干细胞储存库，该存储库将用于识别和表征最适合的细胞，以及未来的治疗者。我们认为，我们非常适合在NHLBI心血管细胞疗法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。（抽象的结尾）