Clinical trial NCT04315025: Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa
Official title: Safety Issues of Peribulbar Injection of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) in Patients With Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa
Keywords: Allogeneic Mesenchymal Stem Cell
Umbilical Cord Mesenchymal Stem Cell
Conditioned Medium
Allogeneic Umbilical Cord Mesenchymal Stem Cell
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Visual Acuity Test
timeFrame: 1 week after injection
measure: Visual Acuity Test
timeFrame: 1 month after injection
measure: Visual Acuity Test
timeFrame: 3 months after injection
measure: Visual Field Test
timeFrame: 1 week after injection
measure: Visual Field Test
timeFrame: 1 month after injection
measure: Visual Field Test
timeFrame: 3 months after injection
measure: Funduscopy
timeFrame: 1 week after injection
measure: Funduscopy
timeFrame: 1 month after injection
measure: Funduscopy
timeFrame: 3 months after injection
measure: Electrorectinography
timeFrame: 1 week after injection
measure: Electrorectinography
timeFrame: 1 month after injection
measure: Electrorectinography
timeFrame: 3 months after injection
measure: Optical Coherence Tomography (OCT)
timeFrame: 1 week after injection
measure: Optical Coherence Tomography (OCT)
timeFrame: 1 month after injection
measure: Optical Coherence Tomography (OCT)
timeFrame: 3 months after injection
measure: Angiography
timeFrame: 1 week after injection
measure: Angiography
timeFrame: 1 month after injection
measure: Angiography
timeFrame: 3 months after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jakarta Eye Center Hospital
state: DKI Jakarta
city: Yogyakarta
country: Indonesia
facility: Sardjito Hospital
state: Special Region
Study officials:
affiliation: Gadjah Mada University, Faculty of Medicine
name: dr Cosmos O Mangunsong, Sp.M
role: PRINCIPAL_INVESTIGATOR
affiliation: Gadjah Mada University, Faculty of Medicine
name: Professor dr. Yohanes W Wirohadidjojo, Sp.KK(K), PhD
role: STUDY_DIRECTOR
affiliation: Prodia Stem Cell Indonesia
name: Bayu W Putera, S.Si, M.Kes
role: STUDY_DIRECTOR
affiliation: Gadjah Mada University, Faculty of Medicine
name: dr Bayu M Sasongko, Sp.M, PhD
role: STUDY_DIRECTOR
affiliation: Jakarta Eye Center
name: dr Melita S Djaja, Sp.M
role: STUDY_CHAIR
affiliation: Jakarta Eye Center
name: dr Amyra D Costa
role: STUDY_CHAIR
affiliation: Prodia StemCell Indonesia
name: Rima Haifa, B.Sc
role: STUDY_CHAIR
References: