An observational study in Retinitis Pigmentosa, sponsored by PT. Prodia Stem Cell Indonesia. Not yet recruiting at 2 sites 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 · Observational
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.
The study will be performed on 18 patients who received UC-MSC and CM transplantation in 2018. The study is included as retrospective cohort since the transplantation happened 5 years ago. Patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observation results will be written in the observation table and analyzed by a statistic.The study will be performed at Rumah Sakit Jakarta Eye Center and Rumah Sakit Umum Pusat Dr. Sardjito Yogyakarta.
Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025
Exclusion Criteria:
2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar
Biological: Conditioned Medium (CM)
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
Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
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
Biological: Conditioned Medium (CM) · Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Conditioned Medium (CM) injected by peribulbar
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 5 years after injection
Angiography
a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
Time frame: 5 years after injection
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