Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
estimated completion
Principal Investigator
by Susanna Park, MD PhD

Description

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.

Official Title

A Pilot Study of the Feasibility and Safety of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Eyes With Vision Loss From Retinitis Pigmentosa

Keywords

Retinitis Pigmentosa stem cell retinal degeneration intravitreal Retinitis Intravitreal autologous CD34+ cells

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  1. Other concurrent optic nerve or retinal disease in study eye affecting vision
  2. History of active retinal or choroidal neovascularization or macular edema in study eye requiring on-going intravitreal or periocular therapy in study eye
  3. Active eye or systemic infection
  4. Significant media opacity in the study eye precluding view of the fundus for examination, photography or optical coherence tomography (OCT)
  5. 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

Location

  • University of California Davis accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Susanna Park, MD PhD
    Professor, Ophthalmology. Authored (or co-authored) 66 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT04925687
Phase
Phase 1
Study Type
Interventional
Last Updated