Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conditioned Medium (CM), Umbilical Cord Mesenchymal Stem Cell (UC-MSC).
- Who it may be relevant to
- Registry conditions: Retinitis Pigmentosa. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa
Overview
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.
Interventions
- Biological Conditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar - Biological Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
Primary outcome measures
- Visual Acuity Test [Time frame: 5 years after injection]
- Visual Field Test [Time frame: 5 years after injection]
- Funduscopy [Time frame: 5 yeas after injection]
- Electrorectinography [Time frame: 5 years after injection]
- Optical Coherence Tomography (OCT) [Time frame: 5 years after injection]
- Angiography [Time frame: 5 years after injection]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Indonesia · 2 centers
- Jakarta Eye Center Hospital — Jakarta
- Sardjito Hospital — Yogyakarta
Identifiers
NCT: NCT05786287 · CT/RP/08/2022