Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

NCT ID: NCT01736059

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2026-10-31

Brief Summary

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This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.

Detailed Description

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In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.

Conditions

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Non-exudative Age-related Macular Degeneration Diabetic Retinopathy Retina Vein Occlusion Retinitis Pigmentosa Hereditary Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem cell treated

Group Type EXPERIMENTAL

CD34+ bone marrow stem cells intravitreal

Intervention Type DRUG

Interventions

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CD34+ bone marrow stem cells intravitreal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \>18 years of age
* visual acuity 20/100 to CF
* duration of vision loss \> 3 months
* vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
* the study eye has the worse visual acuity
* no active eye or systemic disease
* no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
* no significant media opacity
* no coagulopathy or other hematologic abnormality
* no concurrent immunosuppressive therapy
* able to keep follow-up for 6 months

Exclusion Criteria

* allergy to fluorescein dye
* other concurrent retinal or optic nerve disease affecting vision
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanna s Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California Davis Eye Center

Locations

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University of California Davis

Sacramento, California, United States

Site Status

Countries

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United States

References

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Park SS. Cell Therapy Applications for Retinal Vascular Diseases: Diabetic Retinopathy and Retinal Vein Occlusion. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFj1-ORSFj10. doi: 10.1167/iovs.15-17594.

Reference Type BACKGROUND
PMID: 27116667 (View on PubMed)

Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415.

Reference Type RESULT
PMID: 25491299 (View on PubMed)

Related Links

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Other Identifiers

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BMSCRetPilot

Identifier Type: OTHER

Identifier Source: secondary_id

906595

Identifier Type: -

Identifier Source: org_study_id

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