UFRCC for Cardiovascular Cell Therapy Research Network

UFRCC 心血管细胞治疗研究网络

• 批准号: 8811149
• 负责人: Carl J Pepine
• 金额: $ 38.24万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-01 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8811149
• 关键词: Acute; Address; Adverse event; Award; Binding; Blood; Bone Marrow Transplantation; CD34 gene; Cardiac; Cardiovascular system; Catheters; Cause of Death; Cell Therapy; Cell physiology; Cells; Chronic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Committee Members; Communities; Community Practice; Data; Decision Making; Development; Disease; Dose; Enrollment; Ethnic Origin; Exposure to; Florida; Fucosyltransferase; Guidelines; Heart Diseases; Heart failure; Hispanics; Homing; Image; Industry; Intervention; Knowledge; Laboratories; Lead; Letters; Literature; Marrow; Measures; Medical; Medicine; Methods; Myocardial Infarction; National Heart, Lung, and Blood Institute; Nurses; Office for Protection from Research Risks; Orphan Drugs; Outcome; Patient Recruitments; Patient Selection; Patients; Perfusion; Phase; Phase I Clinical Trials; Physicians; Policies; Population; Private Practice; Procedures; Program Development; Protocols documentation; Publications; Puerto Rico; Recruitment Activity; Regenerative Medicine; Reporting; Research; Research Personnel; Resources; Review Committee; Role; Science; Selectins; Site; Site Visit; Stem cells; Syndrome; Techniques; Technology; Testing; Therapeutic Studies; Training; Training Programs; Translating; Transplantation; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Work; base; capitate bone; cell motility; cell type; college; cost effectiveness; disability; expectation; improved; insight; investigator training; knowledge base; meetings; novel; pre-clinical; programs; protocol development; quality assurance; research clinical testing; skills; small molecule; stem cell biology; success; symposium; targeted treatment; vasculogenesis

DESCRIPTION (provided by applicant): The objectives of this application are three fold; renew the University of Florida (UF) Regional Clinical Center (UFRCC) for the Cardiovascular Cell Therapy Research Network (CCTRN); renew the successful Investigator Training Core; and apply for the Clinical Research Coordinator Skill Development Program. Cell therapy is an exciting concept for treatment of CV disease (CVD), but despite abundant preclinical and feasibility clinical studies the ability to translate findings to improve patient outcomes has lagged. To address this need, the UFRCC utilizes established programs in Stem Cell Biology/Regenerative Medicine (T32), Bone Marrow Transplant Center (part of NIH/NCI clinical research network), novel imaging resources, the CTSI, Advanced Heart Failure/ Transplant Program, and CV Clinical Trials Program. In addition to success in CCTRN-1, we have a long record of successful collaborations in multicenter NHLBI and other trials testing strategies to improve cardiac perfusion or function and evaluate clinical outcomes. For this renewal application, we propose that enhancing progenitor cell function will improve cardiac function and lead to better clinical outcomes. Our first protocol addresses enhancing progenitor cell homing after non-STEMI. Novel features include a method to enhance binding to selectins using fucosyltransferase and its substrate (ASC-101) to complete sialylated Lewis X formation. UFRCC investigators have shown that ASC-101 enhances vasculogenesis; it has received orphan drug status for bone marrow transplantation; and is manufactured at a UF GMP-compliant facility. The second protocol uses a novel cell population (CD34+) in high dose for CAD patients with heart failure (like FOCUS). Other novel features include: increasing Angl- 7 by exposure to a small molecule shown by UFRCC investigators to enhance cell migration and vasculogenesis; a new delivery catheter (BioCardia, Helical); and cell selection method (Miltenyi Biotec). Additional unique aspects of the UFRCC include collaborations with University of Puerto Rico, and industry. This work will improve our understanding of the role of cell therapy in CVD patients.

描述（由申请人提供）： 该应用程序的目标有三个：更新佛罗里达大学 (UF) 心血管细胞治疗研究网络 (CCTRN) 区域临床中心 (UFRCC)；更新成功的研究者培训核心；并申请临床研究协调员技能发展计划。细胞疗法是治疗心血管疾病 (CVD) 的一个令人兴奋的概念，但尽管有大量的临床前和可行性临床研究，但将研究结果转化为改善患者预后的能力仍然滞后。为了满足这一需求，UFRCC 利用干细胞生物学/再生医学 (T32)、骨髓移植中心（NIH/NCI 临床研究网络的一部分）、新颖的影像资源、CTSI、高级心力衰竭/移植计划和 CV 临床试验计划等方面的既定计划。除了 CCTRN-1 的成功之外，我们在多中心 NHLBI 和其他试验测试策略方面拥有长期的成功合作记录，以改善心脏灌注或功能并评估临床结果。对于这一更新应用，我们建议增强祖细胞功能将改善心脏功能并带来更好的临床结果。我们的第一个方案致力于增强非 STEMI 后的祖细胞归巢。新颖的特点包括使用岩藻糖基转移酶及其底物 (ASC-101) 增强与选择素结合的方法，以完成唾液酸化路易斯 X 的形成。 UFRCC 研究人员表明 ASC-101 可以增强血管生成；已获得骨髓移植孤儿药地位；并在 UF GMP 合规工厂生产。第二种方案使用高剂量的新型细胞群 (CD34+) 治疗患有心力衰竭的 CAD 患者（如 FOCUS）。其他新特征包括：UFRCC 研究人员显示，通过暴露于小分子来增加 Angl-7，以增强细胞迁移和血管生成；新的输送导管（BioCardia，Helical）；和细胞选择方法（Miltenyi Biotec）。 UFRCC 的其他独特之处包括与波多黎各大学和行业的合作。这项工作将提高我们对细胞疗法在 CVD 患者中的作用的理解。