Retinitis Pigmentosa
Conditions
Keywords
Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell
Brief summary
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
BIOLOGICAL1.5 x 10^6 UC-MSC + CM
1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
BIOLOGICAL5 x 10^6 UC-MSC + CM
5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident of Adverse Events | 1 day after injection | assessment of infection, inflammation, eye pressure and patients complaints |
| Frequency of Adverse Events | 1 day after injection | assessment of infection, inflammation, eye pressure and patients complaints |
| Visual Acuity Test | 1 week 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 | 1 week after injection | a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry. |
| Funduscopy | 1 week 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 | 1 week 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) | 1 week 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Quality of Life | 1 week after injection | Patient's quality of life using National Eye Institute-Visual Functional Questioner 25 |
| Pain evaluation | 6 months after injection | Evaluation on level of pain felt by patients |
| Eye bump | 6 months after injection | Evaluation on appearance of eye bump |
Countries
Indonesia
Contacts
CONTACTdr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
CONTACTDr. Cynthia R Sartika, M.Si
PRINCIPAL_INVESTIGATORdr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
Gadjah Mada University, Faculty of Medicine
STUDY_CHAIRCosmos Mangunsong, Doctor
Jakarta Eye Center
STUDY_CHAIRdr. Rifa Widyaningrum, M.Sc, PhD
Sardjito Hospital
Outcome results
None listed