Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa

Study Overview
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Brief Summary
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The study will perform UC-MSCs and CM transplantation. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

Detailed Description
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The eyes which will give the transplant should be given an aseptic and antiseptic technique to prevent the contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension (for UC-MSC + NaCl group). Stem cell suspension will be injected by peribulbar and if the injection was done, patients will be given a quinolone antibiotic. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increasing of 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 observation results will be written in the observation table and analyzed by a statistic. After the data was completed, then make a discussion, conclusion, and suggestion of the study.

Official Title
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Safety Issues of Peribulbar Injection of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) in Patients With Retinitis Pigmentosa

Conditions
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Retinitis Pigmentosa

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Visual field defects at initial examination with Humhprey perimetry are between 25% to 50% Willing to sign informed consent as research subjects Willing to do 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 Coherrent 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 In 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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 1 week after injection | 
| 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. | 1 month after injection | 
| 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. | 3 months 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. | 1 week 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. | 1 month 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. | 3 months 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. | 1 week 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. | 1 month 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. | 3 months 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. | 1 week 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. | 1 month 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. | 3 months 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 | 1 week 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 | 1 month 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 | 3 months after injection | 
| Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 1 week after injection | 
| Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 1 month after injection | 
| Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 3 months after injection | 

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