We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01736059
Recruitment Status : Enrolling by invitation
First Posted : November 29, 2012
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Non-exudative Age-related Macular Degeneration Diabetic Retinopathy Retina Vein Occlusion Retinitis Pigmentosa Hereditary Macular Degeneration Drug: CD34+ bone marrow stem cells intravitreal Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2012
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Stem cell treated Drug: CD34+ bone marrow stem cells intravitreal


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736059


Locations
Layout table for location information
United States, California
University of California Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Layout table for investigator information
Principal Investigator: Susanna s Park, MD PhD University of California Davis Eye Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01736059    
Other Study ID Numbers: 906595
BMSCRetPilot ( Other Identifier: Other )
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once study is completed, the study findings will be published in peer reviewed publication for public access.
Keywords provided by University of California, Davis:
Stem cells
intravitreal
bone marrow CD34+ cells
 retinal disease
clinical trial
autologous
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Retinitis
Retinitis Pigmentosa
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn