Clinical Trial of Stem Cell Use in Vision Loss

We hope to learn more about the safety and feasibility of using your own (autologous) stem cells extracted from your bone marrow.

a study on Macular Degeneration Diabetes Retinal Vein Occlusion Retinitis Pigmentosa

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Sacramento, California
Dates
study started
completion around
Principal Investigator
by 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, 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 at UC Davis

  • Susanna s Park, MD PhD
    Professor, Ophthalmology, School of Medicine. Authored (or co-authored) 86 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Learn more or sign up for the study here! Sign up for this study
ID
NCT01736059
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated
Contact us about this trial