Ancillary Functional Studies for the CCTRN

描述(由申请人提供)： NHLBI最近成立了心血管细胞治疗研究网络(CCTRN)，以进行治疗心血管疾病的新型细胞治疗临床试验。我们寻求弥合注射细胞和临床结果之间的差距，并将测试注射细胞的功能特征决定患者对骨髓细胞治疗注射的反应这一重要假设。我们建议在细胞治疗注射前测量细胞功能，使我们能够量化细胞功能结果和随后的临床结果之间的关系。具体地说，我们的目标是测试细胞迁移和一氧化氮活性，基于这些机制在预测心肌新生血管方面的已被证实的有效性。虽然所有三个CCTRN试验的移植细胞来源(骨髓)都是相同的(焦点、时间和后期)，但对这项建议感兴趣的临床反应措施是各自试验的主要临床结果。根据注射细胞的功能特征预测细胞治疗干预的结果的能力将极大地加快改善细胞功能和细胞治疗步伐的方法的发展。NHLBI最近成立了心血管细胞治疗研究网络(CCTRN)，以进行治疗心血管疾病的新型细胞治疗临床试验。这项建议建立了一个CCTRN辅助功能研究实验室联盟，以弥合注射细胞和临床结果之间的差距。这项提案中的辅助研究结果对于解释当前的CCTRN试验至关重要，并将用于构建未来的CCTRN细胞治疗试验。(摘要结束)

DESCRIPTION (provided by applicant): The NHLBI recently instituted the Cardiovascular Cell Therapy Research Network (CCTRN) to conduct novel cell therapy clinical trials for the treatment of cardiovascular diseases. We seek to bridge the gap between cells injected and clinical outcome, and will test the overarching hypothesis that functional characteristics of injected cells dictate patients' responses to marrow cell therapy injections. We propose to measure cell function before cell therapy injections, enabling us to quantify relationships between cell function results and subsequent clinical outcomes. Specifically, we aim to test cell migration and nitric oxide activity based on the proven utility of these mechanisms in predicting myocardial neovasculogenesis. Whereas the source of transplanted cells are the same (bone marrow) for all three CCTRN trials (FOCUS, TIME and Late TIME), the clinical response measures of interest for this proposal are the primary clinical outcomes of the respective trial. The ability to predict outcome of a cell therapeutic intervention based on functional characteristics of the injected cells will greatly accelerate development of methods to improve cell function and the pace of cell therapy. The NHLBI recently instituted the Cardiovascular Cell Therapy Research Network (CCTRN) to conduct novel cell therapy clinical trials for the treatment of cardiovascular diseases. This proposal establishes a CCTRN ancillary functional studies laboratory consortium to bridge the gap between cells injected and clinical outcome. Results from ancillary studies in this proposal are crucially important for the interpretation of current CCTRN trials and will be used to construct future CCTRN cell therapy trials. (End of Abstract)