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

December 14, 2023 updated by: University of California, Davis

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Susanna s Park, MD PhD, University of California Davis Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 25, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimated)

November 29, 2012

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 906595
  • BMSCRetPilot (Other Identifier: Other)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once study is completed, the study findings will be published in peer reviewed publication for public access.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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