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

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

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.

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Biological: Conditioned Medium (CM); Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Jakarta Eye Center Hospital
  • Special Region
    • Yogyakarta, Special Region, Indonesia, 55284
      • Sardjito Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conditioned Medium (CM); a total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar	Biological: Conditioned Medium (CM); Conditioned Medium (CM) injected by peribulbar
ACTIVE_COMPARATOR: UC-MSC + NaCl; 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); Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
ACTIVE_COMPARATOR: UC-MSC+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	Biological: Conditioned Medium (CM); Conditioned Medium (CM) injected by peribulbar; Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC); Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

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.	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

Collaborators and Investigators

• Sponsor: PT. Prodia Stem Cell Indonesia
• Investigators: Principal Investigator: dr Cosmos O Mangunsong, Sp.M, Gadjah Mada University, Faculty of Medicine; Study Director: Professor dr. Yohanes W Wirohadidjojo, Sp.KK(K), PhD, Gadjah Mada University, Faculty of Medicine; Study Director: Bayu W Putera, S.Si, M.Kes, Prodia Stem Cell Indonesia; Study Director: dr Bayu M Sasongko, Sp.M, PhD, Gadjah Mada University, Faculty of Medicine; Study Chair: dr Melita S Djaja, Sp.M, Jakarta Eye Center; Study Chair: dr Amyra D Costa, Jakarta Eye Center; Study Chair: Rima Haifa, B.Sc, Prodia StemCell Indonesia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2018
• Primary Completion (ACTUAL): June 20, 2019
• Study Completion (ACTUAL): September 20, 2019

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (ACTUAL): March 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Conditioned Medium; Umbilical Cord Mesenchymal Stem Cell; Allogeneic Mesenchymal Stem Cell; Allogeneic Umbilical Cord Mesenchymal Stem Cell
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: CT/RP/02/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No