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

906595

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.

2012-07-01

2025-10-01

2025-10-01

Active (not recruiting)

Early phase I

15

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2023-12-15