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Not yet recruitingNCT05786287Updated Feb 25, 2026

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

An observational study in Retinitis Pigmentosa, sponsored by PT. Prodia Stem Cell Indonesia. Not yet recruiting at 2 sites in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by PT. Prodia Stem Cell Indonesia · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
18
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Retinitis Pigmentosa

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Keywords

  • Allogeneic Mesenchymal Stem Cell
  • Umbilical Cord Mesenchymal Stem Cell
  • Conditioned Medium
  • Allogeneic Umbilical Cord Mesenchymal Stem Cell
  • Safety
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025

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

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)
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
18 participants (estimated)
Patient registry
No

Groups and cohorts

  • Conditioned Medium (CM)

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

    Biological: Conditioned Medium (CM)

  • 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

    Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

  • 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

    Biological: Conditioned Medium (CM) · Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Interventions

  • BiologicalConditioned Medium (CM)

    Conditioned Medium (CM) injected by peribulbar

  • BiologicalUmbilical Cord Mesenchymal Stem Cell (UC-MSC)

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

05

What researchers measure

Primary outcomes

  1. Visual Acuity Test

    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.

    Time frame: 5 years after injection

  2. Visual Field Test

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

    Time frame: 5 years after injection

  3. Funduscopy

    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.

    Time frame: 5 yeas after injection

  4. Electrorectinography

    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.

    Time frame: 5 years after injection

  5. Optical Coherence Tomography (OCT)

    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

    Time frame: 5 years after injection

  6. Angiography

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

    Time frame: 5 years after injection

06

Study locations

2 sites
  • Jakarta Eye Center Hospital
    Jakarta, DKI Jakarta, Indonesia
  • Sardjito Hospital
    Yogyakarta, Special Region 55284, Indonesia
07

Registry details

Key details

Study ID
NCT05786287
Lead sponsor
PT. Prodia Stem Cell Indonesia
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
May 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Feb 25, 2026

Study contacts

dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
Contact
mb.sasongko@ugm.ac.id
+62 811-293-476
Dr. Cynthia R Sartika, M.Si
Contact
cynthia.sartika@prostem.co.id
dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
principal investigator · Gadjah Mada University, Faculty of Medicine
dr Cosmos O Mangunsong, Sp.M
study director · Jakarta Eye Center
dr. Rifa Widyaningrum, M.Sc, PhD
study chair · Sardjito Hospital
Rima Haifa, S.Si
study chair · Prodia StemCell Indonesia
Marsya N Kirana, S.T., M.Sc
study chair · Prodia StemCell Indonesia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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