Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa

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.

• Conditioned Medium (CM) (Biological): Conditioned Medium (CM) injected by peribulbar
• Umbilical Cord Mesenchymal Stem Cell (UC-MSC) (Biological): Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

Primary outcomes

• 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.

Sex: All, ages: 18 Years to 65 Years

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)

• dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD, Principal investigator, Gadjah Mada University, Faculty of Medicine
• dr Cosmos O Mangunsong, Sp.M, Study director, Jakarta Eye Center
• dr. Rifa Widyaningrum, M.Sc, PhD, Study chair, Sardjito Hospital
• Rima Haifa, S.Si, Study chair, Prodia StemCell Indonesia
• Marsya N Kirana, S.T., M.Sc, Study chair, Prodia StemCell Indonesia