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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Autologous CD34+ cells harvested from bone marrow injected intravitreal
University of California Davis
Sacramento, California, United States
Safety of intravitreal injection of autologous CD34+ cells
Number and severity of Ocular and systemic adverse events
Time frame: 6 months
Feasibility of intravitreal injection of autologous CD34+ cells
Number of CD34+ cells harvested for intravitreal injection
Time frame: Baseline
Best corrected visual acuity
Change in number of letters read in study eye from baseline
Time frame: 6 months
Best corrected visual acuity
Change in number of letters read in study eye from baseline
Time frame: 1 month
Visual Field
Change in visual field area in study eye from baseline
Time frame: 6 months
Visual Field
Change in visual field area in study eye from baseline
Time frame: 1 month
Electroretinography
Change in a and b wave amplitude in study eye from baseline
Time frame: 6 months
Electroretinography
Change in a and b wave amplitude in study eye from baseline
Time frame: 1 month
National Eye Institute Vision Questionnaire
Change in Vision Questionnaire compared to baseline
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Time frame: 6 months
National Eye Institute Vision Questionnaire
Change in Vision Questionnaire compared to baseline
Time frame: 1 month
Microperimetry
Change in average threshold from baseline
Time frame: 6 months
Microperimetry
Change percent reduced sensitivity from baseline
Time frame: 6 months
Microperimetry
Change in average threshold from baseline
Time frame: 1 month
Microperimetry
Change in percent reduced sensitivity from baseline
Time frame: 1 month