Summary

for people ages 18-100 (full criteria)
at Sacramento, California
study started
estimated completion
Susanna s Park, MD PhD

Description

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.

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

Details

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.

Keywords

Non-exudative Age-related Macular Degeneration Diabetic Retinopathy Retina Vein Occlusion Retinitis Pigmentosa Hereditary Macular Degeneration Stem cells intravitreal bone marrow CD34+ cells retinal disease clinical trial autologous Macular Degeneration Retinal Diseases Retinitis Geographic Atrophy CD34+ bone marrow stem cells intravitreal

Eligibility

You can join if…

Open to people ages 18-100

  • 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

You CAN'T join if...

  • allergy to fluorescein dye
  • other concurrent retinal or optic nerve disease affecting vision

Location

  • University of California Davis
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT01736059
Phase
Phase 1
Study Type
Interventional
Last Updated