Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

Retinitis Pigmentosa Clinical Trial

Official title:

Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909488
• Other study ID #: CT/RP/06/2022
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: PT. Prodia Stem Cell Indonesia
• Contact: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
• Phone: +62811293476
• Email: mb.sasongko[@]ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.

Description:

The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) preparations are suspended in Conditioned Medium (CM) until it reaches a 2 ml volume of cell suspension. Two dosages will be prepared, 1.5 million and 5 million of UC-MSC. Stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased 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 observations will be written in the table and analyzed by a statistic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Visus more than 20/100
• Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
• Visual field equivalent diameter more than 10o
• 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 tumors
• Under 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)

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Biological:
• 1.5 x 10^6 UC-MSC + CM
1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
• 5 x 10^6 UC-MSC + CM
5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)

Locations

Country	Name	City	State
Indonesia	RSUP Dr. Sardjito	Yogyakarta	DI Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 day after injection
Primary	Incident of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 week after injection
Primary	Frequency of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 day after injection
Primary	Frequency of Adverse Events	assessment of infection, inflammation, eye pressure and patients complaints	1 week after injection
Primary	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
Primary	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
Primary	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
Primary	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.	6 months after injection
Primary	Visual Field Test	a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.	1 week after injection
Primary	Visual Field Test	a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.	1 month after injection
Primary	Visual Field Test	a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.	3 months after injection
Primary	Visual Field Test	a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.	6 months after injection
Primary	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
Primary	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
Primary	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
Primary	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.	6 months after injection
Primary	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
Primary	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
Primary	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
Primary	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.	6 months after injection
Primary	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
Primary	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
Primary	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
Primary	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.	6 months after injection
Secondary	Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	1 week after injection
Secondary	Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	1 month after injection
Secondary	Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	3 months after injection
Secondary	Patients Quality of Life	Patient's quality of life using National Eye Institute-Visual Functional Questioner 25	6 months after injection
Secondary	Pain evaluation	Evaluation on level of pain felt by patients	6 months after injection
Secondary	Eye bump	Evaluation on appearance of eye bump	6 months after injection