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| Name | Class |
|---|---|
| Cures Within Reach | OTHER |
| The Retina Society | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal autologous CD34+ cells | Experimental | Intravitreal injection of autologous CD34+ cells harvested from bone marrow under GMP conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal autologous CD34+ cells | Biological | Autologous CD34+ cells harvested from bone marrow injected intravitreal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of intravitreal injection of autologous CD34+ cells | Number and severity of Ocular and systemic adverse events | 6 months |
| Feasibility of intravitreal injection of autologous CD34+ cells | Number of CD34+ cells harvested for intravitreal injection | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Change in number of letters read in study eye from baseline | 6 months |
| Best corrected visual acuity | Change in number of letters read in study eye from baseline |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Susanna Park, MD PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95817 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D012162 | Retinal Degeneration |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012164 | Retinal Diseases |
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| 1 month |
| Visual Field | Change in visual field area in study eye from baseline | 6 months |
| Visual Field | Change in visual field area in study eye from baseline | 1 month |
| Electroretinography | Change in a and b wave amplitude in study eye from baseline | 6 months |
| Electroretinography | Change in a and b wave amplitude in study eye from baseline | 1 month |
| National Eye Institute Vision Questionnaire | Change in Vision Questionnaire compared to baseline | 6 months |
| National Eye Institute Vision Questionnaire | Change in Vision Questionnaire compared to baseline | 1 month |
| Microperimetry | Change in average threshold from baseline | 6 months |
| Microperimetry | Change percent reduced sensitivity from baseline | 6 months |
| Microperimetry | Change in average threshold from baseline | 1 month |
| Microperimetry | Change in percent reduced sensitivity from baseline | 1 month |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |