Clinical trial NCT05909488: Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
Official title: Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
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: 2023-06-18
Enrollment: 30
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. 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incident of Adverse Events
timeFrame: 1 day after injection
measure: Incident of Adverse Events
timeFrame: 1 week after injection
measure: Frequency of Adverse Events
timeFrame: 1 day after injection
measure: Frequency of Adverse Events
timeFrame: 1 week after injection
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 Acuity Test
timeFrame: 6 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: Visual Field Test
timeFrame: 6 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: Funduscopy
timeFrame: 6 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: Electrorectinography
timeFrame: 6 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: Optical Coherence Tomography (OCT)
timeFrame: 6 months after injection
Secondary outcomes:
measure: Patients Quality of Life
timeFrame: 1 week after injection
measure: Patients Quality of Life
timeFrame: 1 month after injection
measure: Patients Quality of Life
timeFrame: 3 months after injection
measure: Patients Quality of Life
timeFrame: 6 months after injection
measure: Pain evaluation
timeFrame: 6 months after injection
measure: Eye bump
timeFrame: 6 months after injection
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: RSUP Dr. Sardjito
state: DI Yogyakarta
Study officials:
affiliation: Gadjah Mada University, Faculty of Medicine
name: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jakarta Eye Center
name: dr. Cosmos O Mangunsong, Sp.M
role: STUDY_CHAIR
affiliation: Sardjito Hospital
name: dr. Rifa Widyaningrum, M.Sc, PhD
role: STUDY_CHAIR
affiliation: Prodia StemCell Indonesia
name: Rima Haifa, S.Si
role: STUDY_CHAIR
affiliation: Prodia StemCell Indonesia
name: Marsya N Kirana, S.T., M.Sc
role: STUDY_CHAIR
References: