Retinitis Pigmentosa
Conditions
Keywords
Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell, Safety
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.
Interventions
BIOLOGICALConditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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_DIRECTORdr Cosmos O Mangunsong, Sp.M
Jakarta Eye Center
STUDY_CHAIRdr. Rifa Widyaningrum, M.Sc, PhD
Sardjito Hospital
STUDY_CHAIRRima Haifa, S.Si
Prodia StemCell Indonesia
STUDY_CHAIRMarsya N Kirana, S.T., M.Sc
Prodia StemCell Indonesia
Outcome results
None listed