Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy

This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.

In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.

Inclusion Criteria:

• age >18 years of age
• visual acuity 20/100 to CF
• duration of vision loss > 3 months
• vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
• the study eye has the worse visual acuity
• no active eye or systemic disease
• no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
• no significant media opacity
• no coagulopathy or other hematologic abnormality
• no concurrent immunosuppressive therapy
• able to keep follow-up for 6 months

Exclusion Criteria:

• allergy to fluorescein dye
• other concurrent retinal or optic nerve disease affecting vision