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
Overview
- Phase
- Phase 1
- Intervention
- CD34+ bone marrow stem cells intravitreal
- Conditions
- Non-exudative Age-related Macular Degeneration
- Sponsor
- University of California, Davis
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Incidence and severity of ocular adverse events
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •allergy to fluorescein dye
- •other concurrent retinal or optic nerve disease affecting vision
Arms & Interventions
Stem cell treated
Intervention: CD34+ bone marrow stem cells intravitreal
Outcomes
Primary Outcomes
Incidence and severity of ocular adverse events
Time Frame: 1 day to 6 months
As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.
Secondary Outcomes
- The number of stem cells isolated and injected into the study eye(1 day)