Retinitis PigmentosaNCT05786287
Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
An observational study of Retinitis Pigmentosa, run by PT. Prodia Stem Cell Indonesia at 2 sites in Indonesia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Conditioned Medium (CM) and Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
- How many people
- 18 participants
- Where
- 2 sitesIndonesia
- Study dates
- May 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Cynthia R Sartika, M.Si contact
Indonesia2 sites
Jakarta Eye Center Hospital
Jakarta, DKI Jakarta
Sardjito Hospital
Yogyakarta, Special Region, 55284
About this study
Official title: Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (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.
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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Conditioned Medium (CM), Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
- Keywords
- Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell, Safety
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Conditioned Medium (CM) | 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar Receives: 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 Receives: 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 Receives: Biological: Conditioned Medium (CM); Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years after injection
Visual Field Test
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.
Measured: 5 years after injection
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.
Measured: 5 yeas after injection
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.
Measured: 5 years after injection
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
Measured: 5 years after injection
Angiography
a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
Measured: 5 years after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study startMay 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD, Principal investigator, Gadjah Mada University, Faculty of Medicinedr Cosmos O Mangunsong, Sp.M, Study director, Jakarta Eye Centerdr. Rifa Widyaningrum, M.Sc, PhD, Study chair, Sardjito HospitalRima Haifa, S.Si, Study chair, Prodia StemCell IndonesiaMarsya N Kirana, S.T., M.Sc, Study chair, Prodia StemCell Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786287
- Sponsor's protocol ID
- CT/RP/08/2022
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT05786287
- Acronym / sponsor ID
- CT/RP/08/2022
- Conditions
- Retinitis Pigmentosa
- Keywords
- Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell, Safety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conditioned Medium (CM) | – | Biological: Conditioned Medium (CM)2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar |
| UC-MSC + NaCl | – | Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)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 |
| UC-MSC+CM | – | Biological: Conditioned Medium (CM), Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioned Medium (CM)Conditioned Medium (CM) injected by peribulbar | Biological | Conditioned Medium (CM), UC-MSC+CM |
| Umbilical Cord Mesenchymal Stem Cell (UC-MSC)Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar | Biological | UC-MSC + NaCl, UC-MSC+CM |
Primary outcome
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.
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.
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.
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Cynthia R Sartika, M.Si contact
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa, run by PT. Prodia Stem Cell Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD (+62 811-293-476, mb.sasongko@ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity Test (time frame: 5 years after injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.