NCT01736059

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
2mo left

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2012Oct 2026

Study Start

First participant enrolled

July 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

14.3 years

First QC Date

July 25, 2012

Last Update Submit

January 27, 2026

Conditions

Non-exudative Age-related Macular DegenerationDiabetic RetinopathyRetina Vein OcclusionRetinitis PigmentosaHereditary Macular Degeneration

Keywords

Stem cellsintravitrealbone marrow CD34+ cellsretinal diseaseclinical trialautologous

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of ocular adverse events

    As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.

    1 day to 6 months

Secondary Outcomes (1)

  • The number of stem cells isolated and injected into the study eye

    1 day

Other Outcomes (1)

  • Incidence and severity of systemic adverse events

    1 day to 6 months

Study Arms (1)

Stem cell treated

EXPERIMENTAL
Drug: CD34+ bone marrow stem cells intravitreal

Interventions

CD34+ bone marrow stem cells intravitrealDRUG
Stem cell treated

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • allergy to fluorescein dye
  • other concurrent retinal or optic nerve disease affecting vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Related Publications (2)

  • 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.

    PMID: 27116667BACKGROUND

  • 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.

    PMID: 25491299RESULT

Related Links

MeSH Terms

Conditions

Diabetic RetinopathyRetinitis PigmentosaRetinal Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesEye Diseases, HereditaryRetinal DystrophiesRetinal DegenerationGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Susanna s Park, MD PhD

    University of California Davis Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

November 29, 2012

Study Start

July 1, 2012

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Once study is completed, the study findings will be published in peer reviewed publication for public access.

Locations

US(1)