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NCT Number: NCT05786287

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

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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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jakarta Eye Center Hospital, Jakarta, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conditioned Medium (CM)

Biological

Conditioned Medium (CM) injected by peribulbar

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Biological

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

Primary outcomes

  1. Visual Acuity Test

    Time frame: 5 years after injection

    a test to see the sharpness of vision using Snellen Chart which is read at a distance of 6 meters. Normal eye test results are stated in 6/6.

  2. Visual Field Test

    Time frame: 5 years after injection

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.

  3. Funduscopy

    Time frame: 5 yeas after injection

    an examination to see and assess the abnormalities and conditions in the ocular fundus using an ophthalmoscope. This examination is carried out by an ophthalmologist.

  4. Electrorectinography

    Time frame: 5 years after injection

    an examination to provide a picture of objectivity, a quantitative measure of retinal function to monitor the function of stem cells and ganglion cells in the eye. This examination is carried out by a trained ophthalmologist.

  5. Optical Coherence Tomography (OCT)

    Time frame: 5 years after injection

    is a diagnostic test that give the information about posterior segment structure, which is retina and optic nerve papillae so that it can be used to assess macular abnormalities

  6. Angiography

    Time frame: 5 years after injection

    a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Cynthia R Sartika, M.Si

CONTACT

[email protected]

dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD

CONTACT

[email protected]

+62 811-293-476

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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