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

NIH RePORTER · NIH · UG1 · $431,909 · view on reporter.nih.gov ↗

Abstract

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.

Key facts

NIH application ID
9984370
Project number
5UG1EY028517-03
Recipient
THE EMMES COMPANY, LLC
Principal Investigator
Jennifer Bacik McCormack
Activity code
UG1
Funding institute
NIH
Fiscal year
2020
Award amount
$431,909
Award type
5
Project period
2018-06-15 → 2023-05-31