Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa

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

UNKNOWN

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-07-13

Brief Summary

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The study will perform to follow-up UC-MSCs and CM transplantation. 18 patients will be called back to be examined after 5 years of UC-MSC and/or CM transplantation.

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Detailed Description

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The study will be performed on 18 patients who received UC-MSC and CM transplantation in 2018. The study is included as retrospective cohort since the transplantation happened 5 years ago. Patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observation results will be written in the observation table and analyzed by a statistic.The study will be performed at Rumah Sakit Jakarta Eye Center and Rumah Sakit Umum Pusat Dr. Sardjito Yogyakarta.

Conditions

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Retinitis Pigmentosa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Conditioned Medium (CM)

2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar

Conditioned Medium (CM)

Intervention Type BIOLOGICAL

Conditioned Medium (CM) injected by peribulbar

UC-MSC + NaCl

1.8 ml cell preparations are suspended in physiological NaCl until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension injected into peribulbar

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Intervention Type BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

UC-MSC+CM

1.8 ml cell preparations are suspended in Conditioned Medium (CM) until it reaches a total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) + Conditioned Medium (CM) suspension injected into peribulbar

Conditioned Medium (CM)

Intervention Type BIOLOGICAL

Conditioned Medium (CM) injected by peribulbar

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Intervention Type BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

Interventions

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Conditioned Medium (CM)

Conditioned Medium (CM) injected by peribulbar

Intervention Type BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Visual field defects at the initial examination with Humphrey perimetry are between 25% to 50%
* Willing to sign informed consent as research subjects
* Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue
* Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherent Tomography (OCT) examinations, electroretinogram examinations and fill out a quality of life questionnaire

Exclusion Criteria

* Pregnant or nursing women
* Positive result of HIV test
* Have a history of eye tumours
* In the immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
* Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma
* Do not come to control according to the schedule determined by the researcher (loss to follow up)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No