ClinicalTrials.gg
CompletedNCT04925687BMSCRP1Updated Sep 23, 2024

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

A Phase 1 interventional study of Intravitreal autologous CD34+ cells in Retinitis Pigmentosa, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by University of California, Davis · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2023, 3 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 119 studies in Retinitis Pigmentosa with a site in United States — 20 open to participants now, 44 under way, 6 of them phase 3. Retinitis Pigmentosa · United States.

Enrollment
72nd of 78
4 · median 21
Started
2021
with 10 others
Phase 1
14 of 119
2 open now
Registered
86th of 119
by date

Among the 119 studies in Retinitis Pigmentosa with a site in United States, this one is the 72nd largest by enrollment of the 78 interventional ones that give a count, is one of 11 that started in 2021, is one of 14 in phase 1, and was the 86th registered.

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

Browse Retinitis Pigmentosa studies →

Open to participants now

20 of the 119 studies in Retinitis Pigmentosa with a site in United States are open now. Recruiting first, the newest first:

15 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 49 Retinitis Pigmentosa studies recruiting now, 37 (76%) set no upper age limit and 7 (14%) stop at 75 or younger; 16 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Retinitis Pigmentosa

Keywords

  • retinitis pigmentosa
  • stem cell
  • retinal degeneration
  • intravitreal
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  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)
  1. 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 therapy 13. History of allergy to fluorescein dye
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Intravitreal autologous CD34+ cells

    Intravitreal injection of autologous CD34+ cells harvested from bone marrow under GMP conditions

    Biological: Intravitreal autologous CD34+ cells

Interventions

  • BiologicalIntravitreal autologous CD34+ cells

    Autologous CD34+ cells harvested from bone marrow injected intravitreal

06

What researchers measure

Primary outcomes

  1. Safety of intravitreal injection of autologous CD34+ cells

    Number and severity of Ocular and systemic adverse events

    Time frame: 6 months

  2. Feasibility of intravitreal injection of autologous CD34+ cells

    Number of CD34+ cells harvested for intravitreal injection

    Time frame: Baseline

Secondary outcomes

  1. Best corrected visual acuity

    Change in number of letters read in study eye from baseline

    Time frame: 6 months

  2. Best corrected visual acuity

    Change in number of letters read in study eye from baseline

    Time frame: 1 month

  3. Visual Field

    Change in visual field area in study eye from baseline

    Time frame: 6 months

  4. Visual Field

    Change in visual field area in study eye from baseline

    Time frame: 1 month

  5. Electroretinography

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

    Time frame: 6 months

  6. Electroretinography

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

    Time frame: 1 month

  7. National Eye Institute Vision Questionnaire

    Change in Vision Questionnaire compared to baseline

    Time frame: 6 months

  8. National Eye Institute Vision Questionnaire

    Change in Vision Questionnaire compared to baseline

    Time frame: 1 month

  9. Microperimetry

    Change in average threshold from baseline

    Time frame: 6 months

  10. Microperimetry

    Change percent reduced sensitivity from baseline

    Time frame: 6 months

  11. Microperimetry

    Change in average threshold from baseline

    Time frame: 1 month

  12. Microperimetry

    Change in percent reduced sensitivity from baseline

    Time frame: 1 month

07

Study locations

1 site
  • University of California Davis
    Sacramento, California 95817, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2021 to primary completion in Nov 2023, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2021
First posted
Jun 14, 2021
StartActual
Jun 1, 2021
Primary completionActual
Nov 1, 2023
CompletionActual
Nov 1, 2023
Last update
Sep 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04925687
Collaborators
Cures Within Reach, The Retina Society
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Jun 1, 2021
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023
Last update
Sep 23, 2024

Study contacts

Susanna Park, MD PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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