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

Phase 1

Active, not recruiting

• Conditions: Diabetic Retinopathy; Non-exudative Age-related Macular Degeneration; Retina Vein Occlusion; Retinitis Pigmentosa; Hereditary Macular Degeneration
• Interventions: Drug: CD34+ bone marrow stem cells intravitreal

• Registration Number: NCT01736059
• Lead Sponsor: University of California, Davis

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell treated	CD34+ bone marrow stem cells intravitreal	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of ocular adverse events	1 day to 6 months	As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.

Secondary Outcome Measures

Name	Time	Method
The number of stem cells isolated and injected into the study eye	1 day	Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States