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

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: CD34+ bone marrow stem cells intravitreal


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell treated<br> | Drug: CD34+ bone marrow stem cells intravitreal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous, Stem cells, intravitreal, bone marrow CD34+ cells, retinal disease, clinical trial