Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/23/2019 |
| Start Date: | July 2012 |
| End Date: | January 2020 |
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
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.
cells from bone marrow into the eye as treatment for patients who are irreversibly blind from
various retinal conditions.
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.
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.
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
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