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Susanna S Park; Intravitreal Autologous Bone Marrow CD34+ Cell Therapy for Retinal Vein Occlusion: phase I/II clinical trial. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3905.
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Presentation Description :
It is well accepted that CD34+ cells are endogenous repair cells that are mobilized in response to tissue ischemia for repair. The CD34+ cells include endothelial progenitor cells as well as hematopoietic stem cells. They play an active role in tissue revascularization. Preclinical studies show that these cells home into the damaged retinal vasculature following intravitreal administration and integrate long-term without ocular or systemic adverse effects. Study findings support regenerative effects of these CD34+ cells via direct vascular engraftment and via paracrine mechanisms. A phase 1 clinical trial has been conducted at the study center showing that the autologous intravitreal CD34+ cell therapy is feasible and without major safety concerns. Among eyes treated with persistent vision loss from various retinal conditions, the eye with retinal vein occlusion had the most dramatic improvement following this cell therapy. Thus, an expanded phase I/II study will be conducted to further explore this autologous cell therapy for persistent vision loss associated with retinal vein occlusion.A phase I/II randomized, prospective, double-blinded, sham controlled cross-over study is planned exploring the safety and potential efficacy of intravitreal administration of autologous CD34+ cell isolated from bone marrow as treatment for vision loss associated with retinal vein occlusion. This single-center study will be conducted at the University of California Davis. Emmes Corporation will be the coordinating center. The National Eye Institute is the study sponsor. The study is being conducted under an IND cleared by the Food and Drug Administration. This five-year study will enroll up to twenty eyes from twenty subjects with persistent vision loss associated with retinal vein occlusion. Each subject will be randomized 1:1 to either prompt treatment with autologous CD34+ cells or sham injection with deferred CD34+ cell treatment at 6 months. Each study subject will be followed for 2 years. The primary endpoint of this study will be the incidence and severity of ocular and systemic side-effects associated with the study treatment. The secondary endpoint of this study will be functional and morphologic changes following cell therapy as accessed by clinical examination and various diagnostic modalities.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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