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OpenTrials
Completed

NCT Number: NCT04925687

Phase 1 Study of Intravitreal Autologous CD34+ Stem Cell Therapy for Retinitis Pigmentosa

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal autologous CD34+ cells

Biological

Autologous CD34+ cells harvested from bone marrow injected intravitreal

Primary outcomes

  1. Safety of intravitreal injection of autologous CD34+ cells

    Time frame: 6 months

    Number and severity of Ocular and systemic adverse events

  2. Feasibility of intravitreal injection of autologous CD34+ cells

    Time frame: Baseline

    Number of CD34+ cells harvested for intravitreal injection

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: 6 months

    Change in number of letters read in study eye from baseline

  2. Best corrected visual acuity

    Time frame: 1 month

    Change in number of letters read in study eye from baseline

  3. Visual Field

    Time frame: 6 months

    Change in visual field area in study eye from baseline

  4. Visual Field

    Time frame: 1 month

    Change in visual field area in study eye from baseline

  5. Electroretinography

    Time frame: 6 months

    Change in a and b wave amplitude in study eye from baseline

  6. Electroretinography

    Time frame: 1 month

    Change in a and b wave amplitude in study eye from baseline

  7. National Eye Institute Vision Questionnaire

    Time frame: 6 months

    Change in Vision Questionnaire compared to baseline

  8. National Eye Institute Vision Questionnaire

    Time frame: 1 month

    Change in Vision Questionnaire compared to baseline

  9. Microperimetry

    Time frame: 6 months

    Change in average threshold from baseline

  10. Microperimetry

    Time frame: 6 months

    Change percent reduced sensitivity from baseline

  11. Microperimetry

    Time frame: 1 month

    Change in average threshold from baseline

  12. Microperimetry

    Time frame: 1 month

    Change in percent reduced sensitivity from baseline

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Cures Within Reach
  • The Retina Society

Registry information

Official study title

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

Acronym: BMSCRP1

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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