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

Sponsor

University of California, Davis (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01736059

Collaborator

(none)

Enrollment

Location

Arm

131

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-exudative Age-related Macular Degeneration Diabetic Retinopathy Retina Vein Occlusion Retinitis Pigmentosa Hereditary Macular Degeneration	Drug: CD34+ bone marrow stem cells intravitreal	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stem cell treated	Drug: CD34+ bone marrow stem cells intravitreal

Arm

Intervention/Treatment

Experimental: Stem cell treated

Drug: CD34+ bone marrow stem cells intravitreal

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Incidence and severity of systemic adverse events [1 day to 6 months]
Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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