Cardiovascular Cell Therapy Research Network

心血管细胞治疗研究网络

基本信息

批准号：
8624705
负责人：
Emerson Carvalho Perin
金额：
$ 79.19万
依托单位：
TEXAS HEART INSTITUTE
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 2019-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8624705
关键词：
Adipocytes Adipose tissue Adopted Aftercare Autologous Biodistribution Bone Marrow Bone Marrow Stem Cell Cardiac Cardiomyopathies Cardiovascular Diseases Cardiovascular system Cell Therapy Cell physiology Cells Chronic Clinical Clinical Research Clinical Trials Community Health Centers Comparative Study Conduct Clinical Trials Controlled Clinical Trials Development Doctor of Philosophy Double-Blind Method Enrollment FDA approved Goals Harvest Hearing Heart Heart Diseases Heart failure Hospitals Infarction Infusion procedures Injection of therapeutic agent Institutes Intermittent Claudication Leadership Light Louisiana Maps Medical center Medicine Mesenchymal Stem Cells Methods Monitor Mononuclear Multimedia Myocardial Infarction Myocardial Ischemia N-octanoylglucosylamine Online Systems Outcome Patient Recruitments Patients Perfusion Physician Executives Placebos Population Principal Investigator Procedures Program Development Protocols documentation Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Recruitment Activity Regimen Reporter Genes Research Role Safety Source Staging Stem Cell Research Stem cells Technology Testing Texas Therapeutic Studies United States Universities Work adult stem cell aldehyde dehydrogenases arm cell type control trial experience head-to-head comparison high risk improved innovation insight meetings patient population percutaneous coronary intervention point of care preclinical study precursor cell regenerative skills stem cell therapy technique development

项目摘要

DESCRIPTION (provided by applicant): The Cardiovascular Cell Therapy Research Network (CCTRN) I worked collaboratively to achieve its goal of successfully conducting 3 clinical trials of cell therapy: FOCUS, TIME, and LateTIME. As a Regional Clinical Center (RCC) for CCTRN I, the Texas Heart Institute (THI) contributed significantly to the development, implementation, and enrollment of the 3 trials, CCTRN I adopted our protocol, FOCUS, as one of its trials, and we shared our extensive experience in conducting clinical trials in patients with chronic heart disease as well as our expertise in performing NOGA mapping and injection procedures. THI met 100% of our recruitment goals in the CCTRN I (top in enrollment for FOCUS), aided by our innovative, multimedia campaign for patient recruitment. THI contributed significantly to the CCTRN's satellite strategy for enrollment by recruiting the first VA hospital to the network. Finally, CCTR I overwhelmingly selected our bridging protocol (cell therapy in patients with intermittent claudication) to be implemented in the latter support period. In this application, THI enthusiastically seeks to continue serving as an RCC for CCTRN II, under the leadership of James T. Willerson, MD, President and Medical Director of THI, as PI, and Emerson C. Perin, MD, PhD, Director of Research in Cardiovascular Medicine and the Stem Cell Center at THI, as co-PI. In addition to the VA satellite, THI proposes to add 2 large, strategically located satellit centers to CCTRN II-the University of Texas Southwestern Medical Center in Dallas and the John Ochsner Heart and Vascular Institute in New Orleans. We are also submitting applications for the Clinical Research Skills Development Programs. The aim of our first research protocol is to perform the first head-to-head comparison of the effects of 3 different cell types on cardiac function and perfusion in a randomized, controlled clinical trial in patients with chronic heart disease, with the inclusion of a small tracking arm to study cell fate after delivery into the hear. The aim of our second protocol is to conduct the first randomized, double-blind, controlled clinical trial of the safety and efficacy of stem cell therapy in patients who have the most common presentation of myocardial infarction, non-ST segment elevation myocardial infarction.

描述（由申请人提供）：我与心血管细胞治疗研究网络 (CCTRN) 合作，实现了成功开展 3 项细胞治疗临床试验的目标：FOCUS、TIME 和 LateTIME。作为 CCTRN I 的区域临床中心 (RCC)，德克萨斯心脏研究所 (THI) 对 3 项试验的开发、实施和招募做出了重大贡献，CCTRN I 采用了我们的方案 FOCUS 作为其试验之一，并且我们分享了我们在慢性心脏病患者中进行临床试验的丰富经验，以及我们在执行 NOGA 标测和注射程序方面的专业知识。在我们创新的多媒体患者招募活动的帮助下，THI 100% 实现了 CCTRN I 中的招募目标（FOCUS 注册人数最高）。 THI 通过招募第一家退伍军人管理局医院加入网络，为 CCTRN 的卫星招募战略做出了重大贡献。最后，CCTR I 压倒性地选择了我们的桥接方案（间歇性跛行患者的细胞治疗）在后期支持期实施。在此申请中，THI 热情地寻求继续作为 CCTRN II 的 RCC，在 THI 总裁兼医疗总监 James T. Willerson 医学博士（作为 PI）和 Emerson C. Perin 医学博士、哲学博士（主任）的领导下。作为联合 PI，从事心血管医学和 THI 干细胞中心的研究。除了 VA 卫星之外，THI 还提议在 CCTRN II 中增加 2 个大型、战略性的卫星中心——位于达拉斯的德克萨斯大学西南医学中心和位于新奥尔良的约翰·奥克斯纳心脏和血管研究所。我们还提交临床研究技能发展计划的申请。我们第一个研究方案的目的是在慢性心脏病患者的随机对照临床试验中首次对 3 种不同细胞类型对心脏功能和灌注的影响进行头对头比较，其中包括小型追踪臂，用于研究细胞在进入心脏后的命运。我们第二个方案的目的是对最常见的心肌梗死、非 ST 段抬高型心肌梗死患者进行干细胞治疗的安全性和有效性的第一个随机、双盲、对照临床试验。