RSUP Dr. Sardjito
Yogyakarta, DI Yogyakarta, 55284, Indonesia
Location contact
Bayu Sasongko, PhD
PRINCIPAL_INVESTIGATOR
Cosmos Mangunsong, Dr
SUB_INVESTIGATOR
Rifa Widyaningrum, PhD
CONTACT
Not Yet Recruiting
NCT Number: NCT05909488
Role of UC-MSC and CM 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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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)
Treatment and study plan
1.5 x 10^6 UC-MSC + CM
Biological1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
5 x 10^6 UC-MSC + CM
Biological5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
Primary outcomes
-
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.
Secondary outcomes
-
Patients Quality of Life
Time frame: 1 week after injection
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
-
Patients Quality of Life
Time frame: 1 month after injection
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
-
Patients Quality of Life
Time frame: 3 months after injection
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
-
Patients Quality of Life
Time frame: 6 months after injection
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
-
Pain evaluation
Time frame: 6 months after injection
Evaluation on level of pain felt by patients
-
Eye bump
Time frame: 6 months after injection
Evaluation on appearance of eye bump
Study contacts
Contact information is provided by the study sponsor or research team.
Dr. Cynthia R Sartika, M.Si
CONTACT
dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
PT. Prodia Stem Cell Indonesia
Industry
Registry information
Official study title
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 18, 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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