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

Study Overview
=================
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.

Official Title
-----------------
Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa

Conditions
-----------------
Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Biological: Conditioned Medium (CM)
* Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conditioned Medium (CM)<br>2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar | Biological: Conditioned Medium (CM)<br>* Conditioned Medium (CM) injected by peribulbar<br>|
| UC-MSC + NaCl<br>1.8 ml cell preparations are suspended in physiological NaCl until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension injected into peribulbar | Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)<br>* Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar<br>|
| UC-MSC+CM<br>1.8 ml cell preparations are suspended in Conditioned Medium (CM) until it reaches a total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) + Conditioned Medium (CM) suspension injected into peribulbar | Biological: Conditioned Medium (CM)<br>* Conditioned Medium (CM) injected by peribulbar<br>Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)<br>* Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity Test | 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. | 5 years after injection | 
| Visual Field Test | a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry. | 5 years after injection | 
| Funduscopy | 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. | 5 yeas after injection | 
| Electrorectinography | 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. | 5 years after injection | 
| Optical Coherence Tomography (OCT) | 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 | 5 years after injection | 
| Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 5 years after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell, Safety