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

Retinitis Pigmentosa Clinical Trial

— RP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315025
• Other study ID #: CT/RP/02/2018
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 7, 2018
• Est. completion date: September 20, 2019

Study information

• Verified date: March 2020
• Source: PT. Prodia Stem Cell Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Biological:
• Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
• Conditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar

Locations

Country	Name	City	State
Indonesia	Jakarta Eye Center Hospital	Jakarta	DKI Jakarta
Indonesia	Sardjito Hospital	Yogyakarta	Special Region

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	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 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
Primary	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
Primary	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
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	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	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	Angiography	a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.	1 week after injection
Primary	Angiography	a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.	1 month after injection
Primary	Angiography	a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.	3 months after injection