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

点击翻译按钮获取中文摘要

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.