Pilot Study of Intravitreal Autologous CD34+ Stem Cell Therapy for Retinitis Pigmentosa (BMSCRP1)

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    4
  • sponsor
    University of California, Davis
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Updated on 7 October 2022
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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.

Details
Condition Retinitis Pigmentosa
Treatment Intravitreal autologous CD34+ cells
Clinical Study IdentifierNCT04925687
SponsorUniversity of California, Davis
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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)
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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