Trials / Active Not Recruiting
Active Not RecruitingNCT01736059
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Non-exudative Age-related Macular Degeneration
- Diabetic Retinopathy
- Retina Vein Occlusion
- Retinitis Pigmentosa
- Hereditary Macular Degeneration
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CD34+ bone marrow stem cells intravitreal |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2012-11-29
- Last updated
- 2026-01-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01736059. Inclusion in this directory is not an endorsement.