At a glance
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Phase I/II Randomized, Prospective, Double-masked, Sham-controlled Study of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Central Retinal Vein Occlusion
In Brief
A Phase 2 clinical trial evaluating Autologous Bone Marrow CD34+ Stem Cells and Sham Therapy for Central Retinal Vein Occlusion. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 1 year.
Study Details
Timeline
Interventions
Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure.
Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye