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Active, Not Recruiting

NCT Number: NCT01736059

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non-exudative Age-related Macular Degeneration Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hereditary Macular Degeneration Retina Vein Occlusion Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CD34+ bone marrow stem cells intravitreal

Drug

Primary outcomes

  1. Incidence and severity of ocular adverse events

    Time frame: 1 day to 6 months

    As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.

Secondary outcomes

  1. The number of stem cells isolated and injected into the study eye

    Time frame: 1 day

    Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.

Other outcomes

  1. Incidence and severity of systemic adverse events

    Time frame: 1 day to 6 months

    Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2012
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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