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

Phase 1

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Biological: Conditioned Medium (CM); Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

• Registration Number: NCT04315025
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-10-07
• Primary Completion: 2019-06-20
• Study Completion: 2019-09-20
• Status Verified: 2020-03
• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conditioned Medium (CM)	Conditioned Medium (CM)	a total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar
UC-MSC+CM	Umbilical Cord Mesenchymal Stem Cell (UC-MSC)	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
UC-MSC + NaCl	Umbilical Cord Mesenchymal Stem Cell (UC-MSC)	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
UC-MSC+CM	Conditioned Medium (CM)	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

Primary Outcome Measures

Name	Time	Method
Visual Acuity Test	3 months 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	3 months after injection	a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.
Funduscopy	3 months 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.
Angiography	3 months after injection	a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
Electrorectinography	3 months 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)	3 months 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

Trial Locations

Locations (2)

Sardjito Hospital; 🇮🇩 Yogyakarta, Special Region, Indonesia

Jakarta Eye Center Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia