Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
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: 1.5 x 10^6 UC-MSC + CM, 5 x 10^6 UC-MSC + CM.
- 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
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
Overview
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.
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.
Interventions
- Biological 1.5 x 10^6 UC-MSC + CM
1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM) - Biological 5 x 10^6 UC-MSC + CM
5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
Primary outcome measures
- Incident of Adverse Events [Time frame: 1 day after injection]
- Incident of Adverse Events [Time frame: 1 week after injection]
- Frequency of Adverse Events [Time frame: 1 day after injection]
- Frequency of Adverse Events [Time frame: 1 week after injection]
- Visual Acuity Test [Time frame: 1 week after injection]
- Visual Acuity Test [Time frame: 1 month after injection]
- Visual Acuity Test [Time frame: 3 months after injection]
- Visual Acuity Test [Time frame: 6 months after injection]
- Visual Field Test [Time frame: 1 week after injection]
- Visual Field Test [Time frame: 1 month after injection]
Secondary outcome measures (6)
- Patients Quality of Life [Time frame: 1 week after injection]
- Patients Quality of Life [Time frame: 1 month after injection]
- Patients Quality of Life [Time frame: 3 months after injection]
- Patients Quality of Life [Time frame: 6 months after injection]
- Pain evaluation [Time frame: 6 months after injection]
- Eye bump [Time frame: 6 months after injection]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- RSUP Dr. Sardjito — Yogyakarta
Identifiers
NCT: NCT05909488 · CT/RP/06/2022