Retinitis PigmentosaPhase 2/3NCT05909488
Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
A Phase 2/3 study testing 1.5 x 10^6 UC-MSC + CM and 5 x 10^6 UC-MSC + CM in people with Retinitis Pigmentosa, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. 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?
- 1.5 x 10^6 UC-MSC + CM and 5 x 10^6 UC-MSC + CM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2026to Sep 2027
- Phase
- Phase 2/3
- 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
Who may be able to join
- Visus more than 20/100
- Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
- Visual field equivalent diameter more than 10o
- 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 tumors
- Under 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Cynthia R Sartika, M.Si contact
Indonesia1 site
RSUP Dr. Sardjito
Yogyakarta, DI Yogyakarta, 55284
Rifa Widyaningrum, PhD, 082134546400
Bayu Sasongko, PhD
About this study
Official title: Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
Read the detailed description
The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) preparations are suspended in Conditioned Medium (CM) until it reaches a 2 ml volume of cell suspension. Two dosages will be prepared, 1.5 million and 5 million of UC-MSC. Stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased eye pressure. On day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observations will be written in the table and analyzed by a statistic.
- Conditions
- Retinitis Pigmentosa
- Being tested
- 1.5 x 10^6 UC-MSC + CM, 5 x 10^6 UC-MSC + CM
- Keywords
- Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 x 10^6 UC-MSC + CMBiological
1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
5 x 10^6 UC-MSC + CMBiological
5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
| Study group | Role | What they receive |
|---|---|---|
| EYESTEM 001-X | Experimental | 1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar. Receives: Biological: 1.5 x 10^6 UC-MSC + CM |
| EYESTEM 001-XF | Experimental | 1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar. Receives: Biological: 5 x 10^6 UC-MSC + CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Measured: 1 day after injection
Incident of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Measured: 1 week after injection
Frequency of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Measured: 1 day after injection
Frequency of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Measured: 1 week after injection
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: 1 week after injection
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: 1 month after injection
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: 3 months after injection
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: 6 months after injection
Visual Field Test
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Measured: 1 week after injection
Visual Field Test
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Measured: 1 month after injection
Visual Field Test
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Measured: 3 months after injection
Visual Field Test
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Measured: 6 months 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: 1 week 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: 1 month 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: 3 months 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: 6 months 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: 1 week 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: 1 month 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: 3 months 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: 6 months 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: 1 week 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: 1 month 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: 3 months 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: 6 months after injection
Secondary outcomes (6)
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Measured: 1 week after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Measured: 1 month after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Measured: 3 months after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Measured: 6 months after injection
Pain evaluation
Evaluation on level of pain felt by patients
Measured: 6 months after injection
Eye bump
Evaluation on appearance of eye bump
Measured: 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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 MedicineCosmos Mangunsong, Doctor, Study chair, Jakarta Eye Centerdr. Rifa Widyaningrum, M.Sc, PhD, Study chair, Sardjito Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909488
- Sponsor's protocol ID
- CT/RP/06/2022
- 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
- Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
- ClinicalTrials.gov ID
- NCT05909488
- Acronym / sponsor ID
- CT/RP/06/2022
- Conditions
- Retinitis Pigmentosa
- Keywords
- Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 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
- 18 Jun 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 UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
Detailed description
The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) preparations are suspended in Conditioned Medium (CM) until it reaches a 2 ml volume of cell suspension. Two dosages will be prepared, 1.5 million and 5 million of UC-MSC. Stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased eye pressure. On day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observations will be written in the table and analyzed by a statistic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EYESTEM 001-X | Experimental | Biological: 1.5 x 10^6 UC-MSC + CM1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar. |
| EYESTEM 001-XF | Experimental | Biological: 5 x 10^6 UC-MSC + CM1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Visus more than 20/100
- Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
- Visual field equivalent diameter more than 10o
- Willing to sign informed consent as research subjects
- Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue
Key exclusion criteria (6 listed)
- Pregnant or nursing women
- Positive result of HIV test
- Have a history of eye tumors
- Under 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 |
|---|---|---|
| 1.5 x 10^6 UC-MSC + CM1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM) | Biological | EYESTEM 001-X |
| 5 x 10^6 UC-MSC + CM5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM) | Biological | EYESTEM 001-XF |
Primary outcome
Incident of Adverse Events
Time frame: 1 day after injection
assessment of infection, inflammation, eye pressure and patients complaints
Incident of Adverse Events
Time frame: 1 week after injection
assessment of infection, inflammation, eye pressure and patients complaints
Frequency of Adverse Events
Time frame: 1 day after injection
assessment of infection, inflammation, eye pressure and patients complaints
Frequency of Adverse Events
Time frame: 1 week after injection
assessment of infection, inflammation, eye pressure and patients complaints
Visual Acuity Test
Time frame: 1 week 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 Acuity Test
Time frame: 1 month 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 Acuity Test
Time frame: 3 months 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 Acuity Test
Time frame: 6 months 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: 1 week after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Visual Field Test
Time frame: 1 month after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Visual Field Test
Time frame: 3 months after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Visual Field Test
Time frame: 6 months after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Funduscopy
Time frame: 1 week 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.
Funduscopy
Time frame: 1 month 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.
Funduscopy
Time frame: 3 months 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.
Funduscopy
Time frame: 6 months 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: 1 week 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.
Electrorectinography
Time frame: 1 month 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.
Electrorectinography
Time frame: 3 months 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.
Electrorectinography
Time frame: 6 months 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: 1 week 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.
Optical Coherence Tomography (OCT)
Time frame: 1 month 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.
Optical Coherence Tomography (OCT)
Time frame: 3 months 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.
Optical Coherence Tomography (OCT)
Time frame: 6 months 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 secondary outcomes
Patients Quality of Life
Time frame: 1 week after injection
Patients Quality of Life
Time frame: 1 month after injection
Patients Quality of Life
Time frame: 3 months after injection
Patients Quality of Life
Time frame: 6 months after injection
Pain evaluation
Time frame: 6 months after injection
Eye bump
Time frame: 6 months after injection
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.
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
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
Cosmos Mangunsong, Doctor study chair
Jakarta Eye Center
dr. Rifa Widyaningrum, M.Sc, PhD study chair
Sardjito Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1.5 x 10^6 UC-MSC + CM and 5 x 10^6 UC-MSC + CM in people with Retinitis Pigmentosa, run by PT. Prodia Stem Cell Indonesia at 1 site 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 6 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 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+62811293476, 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?
Incident of Adverse Events (time frame: 1 day after injection). The study lists 24 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.