Phase 1 Study of the Feasibility and Safety of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Eyes With Vision Loss From Retinitis Pigmentosa
Overview
- Phase
- Phase 1
- Intervention
- Intravitreal autologous CD34+ cells
- Conditions
- Retinitis Pigmentosa
- Sponsor
- University of California, Davis
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Safety of intravitreal injection of autologous CD34+ cells
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
In this Phase 1 open-labeled prospective study, one eye of each participant with vision loss from retinitis pigmentosa will be administered intravitreal injection of autologous CD34+ stem cells harvested from bone marrow. Each participant will be examined serially for 6 months after study injection to determine safety and feasibility of this intervention.
Investigators
Susanna Park, MD, PhD
Professor
University of California, Davis
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years of age
- •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
- •Vision loss due to retinitis pigmentosa
- •The study eye has the worse visual acuity or peripheral constriction.
- •Able and willing to sign consent
- •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)
- •Other cause for vision loss in the study eye
- •History of coagulopathy or other hematologic abnormality
- •Use of coumadin within 3 days of enrollment
- •Concurrent immunosuppressive therapy
- •History of allergy to fluorescein dye
Arms & Interventions
Intravitreal autologous CD34+ cells
Intravitreal injection of autologous CD34+ cells harvested from bone marrow under GMP conditions
Intervention: Intravitreal autologous CD34+ cells
Outcomes
Primary Outcomes
Safety of intravitreal injection of autologous CD34+ cells
Time Frame: 6 months
Number and severity of Ocular and systemic adverse events
Feasibility of intravitreal injection of autologous CD34+ cells
Time Frame: Baseline
Number of CD34+ cells harvested for intravitreal injection
Secondary Outcomes
- Visual Field(1 month)
- National Eye Institute Vision Questionnaire(1 month)
- Best corrected visual acuity(1 month)
- Microperimetry(1 month)
- Electroretinography(1 month)