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Treatment of Central Retinal Vein Occlusion Using Stem Cells Study

NCT03981549 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-02

Study results available
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Summary

This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 1 year.

Conditions

  • Central Retinal Vein Occlusion

Interventions

BIOLOGICAL

Autologous Bone Marrow CD34+ Stem Cells

Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure.

BIOLOGICAL

Sham Therapy

Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • University of California, Davis

    collaborator OTHER

  • The Emmes Company, LLC

    lead INDUSTRY

Principal Investigators

  • Susanna S Park, MD, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2023-11-07
Completion
2023-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981549 on ClinicalTrials.gov