Diabetic Retinopathy, Hereditary Macular Degeneration, Non-exudative Age-related Macular Degeneration, Retina Vein Occlusion, Retinitis Pigmentosa
Conditions
Keywords
Stem cells, intravitreal, bone marrow CD34+ cells, retinal disease, clinical trial, autologous
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.
Interventions
DRUGCD34+ bone marrow stem cells intravitreal
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of ocular adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| The number of stem cells isolated and injected into the study eye | 1 day | Will determine the yield of the bone marrow aspiration and stem cell isolation procedures. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusanna s Park, MD PhD
University of California Davis Eye Center
Outcome results
None listed