A Phase 2/3 interventional study of 1.5 x 10^6 UC-MSC + CM and 5 x 10^6 UC-MSC + CM in Retinitis Pigmentosa, sponsored by PT. Prodia Stem Cell Indonesia. Not yet recruiting at 1 site 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 · Phase 2/3, Interventional, and Treatment
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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.
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.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 30 is above the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →PT. Prodia Stem Cell Indonesia is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: 1.5 x 10^6 UC-MSC + CM
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.
Biological: 5 x 10^6 UC-MSC + CM
1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
Incident of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Time frame: 1 day after injection
Incident of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Time frame: 1 week after injection
Frequency of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Time frame: 1 day after injection
Frequency of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Time frame: 1 week after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Time frame: 1 month after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Time frame: 3 months after injection
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Time frame: 6 months after injection
Pain evaluation
Evaluation on level of pain felt by patients
Time frame: 6 months after injection
Eye bump
Evaluation on appearance of eye bump
Time frame: 6 months after injection
Start is estimated for May 2026; primary completion for Jul 2027, 14 months later.
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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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PT. Prodia Stem Cell Indonesia