Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa
1 other identifier
observational
18
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 25, 2026
February 1, 2026
1.2 years
March 14, 2023
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
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.
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.
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.
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
5 years after injection
Angiography
a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
5 years after injection
Study Arms (3)
Conditioned Medium (CM)
2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar
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
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
Interventions
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
Conditioned Medium (CM) injected by peribulbar
Eligibility Criteria
Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jakarta Eye Center Hospital
Jakarta, DKI Jakarta, Indonesia
Sardjito Hospital
Yogyakarta, Special Region, 55284, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
Gadjah Mada University, Faculty of Medicine
- STUDY DIRECTOR
dr Cosmos O Mangunsong, Sp.M
Jakarta Eye Center
- STUDY CHAIR
dr. Rifa Widyaningrum, M.Sc, PhD
Sardjito Hospital
- STUDY CHAIR
Rima Haifa, S.Si
Prodia StemCell Indonesia
- STUDY CHAIR
Marsya N Kirana, S.T., M.Sc
Prodia StemCell Indonesia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
March 27, 2023
Study Start
May 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02