Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa
RP
1 other identifier
interventional
18
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedFirst Submitted
Initial submission to the registry
March 8, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedJune 4, 2020
March 1, 2020
9 months
March 8, 2020
June 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
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
Study Arms (3)
Conditioned Medium (CM)
ACTIVE COMPARATORa total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar
UC-MSC + NaCl
ACTIVE COMPARATOR1.8 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
UC-MSC+CM
ACTIVE COMPARATOR1.8 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
Interventions
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
Conditioned Medium (CM) injected by peribulbar
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jakarta Eye Center Hospital
Jakarta, DKI Jakarta, Indonesia
Sardjito Hospital
Yogyakarta, Special Region, 55284, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2020
First Posted
March 19, 2020
Study Start
October 7, 2018
Primary Completion
June 20, 2019
Study Completion
September 20, 2019
Last Updated
June 4, 2020
Record last verified: 2020-03