Phase I/II Randomized, Prospective, Double-blinded, Sham-controlled Cross-over Study of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Retinal Vein Occlusion

玻璃体内自体骨髓 CD34 干细胞治疗视网膜静脉阻塞的 I/II 期随机、前瞻性、双盲、假手术对照交叉研究

• 批准号: 10408144
• 负责人: Jennifer Bacik McCormack
• 金额: $ 31.55万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10408144
• 关键词: Adherence; Adult; Area; Autologous; Blindness; Bone Marrow; CD34 gene; Clinical Trials; Collaborations; Conduct Clinical Trials; Cross-Over Studies; Data; Data Collection; Data Coordinating Center; Data Reporting; Double-Blind Method; Ensure; Funding; Leadership; Masks; Monitor; Online Systems; Phase; Preparation; Principal Investigator; Protocols documentation; Quality Control; Randomized; Reporting; Research Design; Retinal Vein Occlusion; Safety; Site; System; Testing; bone cell; clinical center; data management; design; human subject; intravitreal injection; meetings; novel; procedure safety; prospective; protocol development; quality assurance; retinal ischemia; safety study; sham-controlled study; stem cell therapy

PROJECT ABSTRACT The CD34RVO trial is a phase I/II randomized, prospective, double-masked, sham-controlled study with cross- over to determine the feasibility, safety and potential efficacy of intravitreal injection of autologous adult CD34+ cells from bone marrow in subjects with vision loss from retinal vein occlusion. The Emmes Corporation will serve as the Data Coordinating Center (DCC) for the CD34RVO study. In collaboration with the Study Chair, the DCC provides overall study leadership to CD34RVO mainly in areas of data management, statistical and operational support to include: statistical leadership in the study design; interim safety and study data reports to the Data and Safety Monitoring Committee; preparation of study results in collaboration with other study leadership and dissemination of findings; design and implementation of a web-based data collection system; support of the Clinical Center from study initiation to study closeout, including site monitoring to ensure proper conduct of the study and good quality data; provision of quality assurance and quality control oversight, and provision of administrative and meeting support.

项目摘要 CD34RVO试验是一项I/II期随机、前瞻性、双掩蔽、假对照研究，交叉试验 目的：确定自体成人CD34+玻璃体腔内注射的可行性、安全性和潜在疗效 视网膜静脉阻塞致失明患者的骨髓细胞。埃默斯公司将 担任CD34RVO研究的数据协调中心(DCC)。与研究主席合作， DCC为CD34RVO提供总体研究领导，主要是在数据管理、统计和 业务支持包括：研究设计中的统计领导；临时安全和研究数据报告 提交给数据和安全监测委员会；与其他研究合作编写研究结果 领导和传播调查结果；设计和实施网上数据收集系统； 支持临床中心从研究开始到研究结束，包括现场监测，以确保适当 进行研究和高质量的数据；提供质量保证和质量控制监督；以及 提供行政和会议支持。