Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
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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.
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Ages Eligible for Study:
18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
allergy to fluorescein dye
other concurrent retinal or optic nerve disease affecting vision