Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
- Conditions
- Retinitis Pigmentosa
- Interventions
- Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)Biological: Conditioned Medium (CM)
- Registration Number
- NCT05786287
- Lead Sponsor
- PT. Prodia Stem Cell Indonesia
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 18
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description UC-MSC + NaCl Umbilical Cord Mesenchymal Stem Cell (UC-MSC) 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 Conditioned Medium (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 Conditioned Medium (CM) Conditioned Medium (CM) 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar UC-MSC+CM 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
- Primary Outcome Measures
Name Time Method Visual Acuity Test 5 years 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 5 years after injection a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.
Funduscopy 5 yeas 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 5 years 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) 5 years 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
Angiography 5 years after injection a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Jakarta Eye Center Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia
Sardjito Hospital
🇮🇩Yogyakarta, Special Region, Indonesia