Phase 1 Study of Intravitreal Autologous CD34+ Stem Cell Therapy for Retinitis Pigmentosa

NCT ID: NCT04925687

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-11-01

Brief Summary

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In this Phase 1 open-labeled prospective study, one eye of each participant with vision loss from retinitis pigmentosa will be administered intravitreal injection of autologous CD34+ stem cells harvested from bone marrow. Each participant will be examined serially for 6 months after study injection to determine safety and feasibility of this intervention.

Detailed Description

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Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal autologous CD34+ cells

Intravitreal injection of autologous CD34+ cells harvested from bone marrow under GMP conditions

Group Type EXPERIMENTAL

Intravitreal autologous CD34+ cells

Intervention Type BIOLOGICAL

Autologous CD34+ cells harvested from bone marrow injected intravitreal

Interventions

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Intravitreal autologous CD34+ cells

Autologous CD34+ cells harvested from bone marrow injected intravitreal

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1\. Age \>18 years of age 2. Visual Acuity at Presentation of 20/100 to Counting Fingers or constriction of peripheral visual field 360 degrees to \<10 degrees by perimetry if BCVA is better than 20/100, duration of vision loss \> 3 months 3. Vision loss due to retinitis pigmentosa 4. The study eye has the worse visual acuity or peripheral constriction. 14. Able and willing to sign consent 15. Able to keep follow-up appointments for at least 6 months

Exclusion Criteria

1. Other concurrent optic nerve or retinal disease in study eye affecting vision
2. History of active retinal or choroidal neovascularization or macular edema in study eye requiring on-going intravitreal or periocular therapy in study eye
3. Active eye or systemic infection
4. Significant media opacity in the study eye precluding view of the fundus for examination, photography or optical coherence tomography (OCT)

9\. Other cause for vision loss in the study eye 10. History of coagulopathy or other hematologic abnormality 11. Use of coumadin within 3 days of enrollment 12. Concurrent immunosuppressive therapy 13. History of allergy to fluorescein dye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cures Within Reach

OTHER

Sponsor Role collaborator

The Retina Society

UNKNOWN

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanna Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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1743714

Identifier Type: -

Identifier Source: org_study_id

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