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

Diabetic Retinopathy Clinical Trial

Official title:

A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01736059
• Other study ID #: 906595
• Secondary ID: BMSCRetPilot
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 2012
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• CD34+ bone marrow stem cells intravitreal

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Ophtha — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and severity of systemic adverse events	Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.	1 day to 6 months
Primary	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	The number of stem cells isolated and injected into the study eye	Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.	1 day

External Links

•   Learn more or sign up for the study here!