Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Biological: 1.5 x 10^6 UC-MSC + CM; Biological: 5 x 10^6 UC-MSC + CM

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD; Phone Number: +62811293476; Email: mb.sasongko@ugm.ac.id
• Study Contact Backup: Name: Dr. Cynthia R Sartika, M.Si; Email: cynthia.sartika@prostem.co.id

Study Locations

• Indonesia
  • DI Yogyakarta
    • Yogyakarta, DI Yogyakarta, Indonesia, 55284
      • RSUP Dr. Sardjito
      • Contact: Rifa Widyaningrum, PhD; Phone Number: 082134546400
      • Principal Investigator: Bayu Sasongko, PhD
      • Sub-Investigator: Cosmos Mangunsong, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EYESTEM 001-X; 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; 1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
Experimental: EYESTEM 001-XF; 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; 5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	3 months after injection
Incident of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 day after injection
Incident of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 week after injection
Frequency of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 day after injection
Frequency of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	1 week after injection
Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	1 month after injection
Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	3 months after injection
Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	6 months after injection
Pain evaluation	Evaluation on level of pain felt by patients	6 months after injection
Eye bump	Evaluation on appearance of eye bump	6 months after injection

Collaborators and Investigators

• Sponsor: PT. Prodia Stem Cell Indonesia
• Investigators: Principal Investigator: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD, Gadjah Mada University, Faculty of Medicine; Study Chair: dr. Rifa Widyaningrum, M.Sc, PhD, Sardjito Hospital; Study Chair: Cosmos Mangunsong, Doctor, Jakarta Eye Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Conditioned Medium; Umbilical Cord Mesenchymal Stem Cell; Allogeneic Mesenchymal Stem Cell; Allogeneic Umbilical Cord Mesenchymal Stem Cell
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Eye Diseases, Hereditary; Retinal Diseases; Retinal Dystrophies; Retinal Degeneration; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinitis Pigmentosa
• Other Study ID Numbers: CT/RP/06/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No