Phase 1 Study of Intravitreal Autologous CD34+ Stem Cell Therapy for Retinitis Pigmentosa (BMSCRP1)
Retinitis Pigmentosa
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa, stem cell, retinal degeneration, intravitreal
Eligibility Criteria
Inclusion Criteria:
1. Age >18 years of age 2. Visual Acuity at Presentation of 20/100 to Counting Fingers or constriction of peripheral visual field 360 degrees to <10 degrees by perimetry if BCVA is better than 20/100, duration of vision loss > 3 months 3. Vision loss due to retinitis pigmentosa 4. The study eye has the worse visual acuity or peripheral constriction. 14. Able and willing to sign consent 15. Able to keep follow-up appointments for at least 6 months
Exclusion Criteria:
- Other concurrent optic nerve or retinal disease in study eye affecting vision
- History of active retinal or choroidal neovascularization or macular edema in study eye requiring on-going intravitreal or periocular therapy in study eye
- Active eye or systemic infection
- Significant media opacity in the study eye precluding view of the fundus for examination, photography or optical coherence tomography (OCT)
9. Other cause for vision loss in the study eye 10. History of coagulopathy or other hematologic abnormality 11. Use of coumadin within 3 days of enrollment 12. Concurrent immunosuppressive therapy 13. History of allergy to fluorescein dye
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Experimental
Intravitreal autologous CD34+ cells
Intravitreal injection of autologous CD34+ cells harvested from bone marrow under GMP conditions