Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase II/III
Study Details
Study Description
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 15 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EYESTEM 001-X 1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar. |
Biological: 1.5 x 10^6 UC-MSC + CM
1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
|
| Experimental: EYESTEM 001-XF 1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar. |
Biological: 5 x 10^6 UC-MSC + CM
5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
|
Outcome Measures
Primary Outcome Measures
- Incident of Adverse Events [1 day after injection]
assessment of infection, inflammation, eye pressure and patients complaints
- Incident of Adverse Events [1 week after injection]
assessment of infection, inflammation, eye pressure and patients complaints
- Frequency of Adverse Events [1 day after injection]
assessment of infection, inflammation, eye pressure and patients complaints
- Frequency of Adverse Events [1 week after injection]
assessment of infection, inflammation, eye pressure and patients complaints
- Visual Acuity Test [1 week after injection]
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.
- Visual Acuity Test [1 month after injection]
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.
- Visual Acuity Test [3 months after injection]
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.
- Visual Acuity Test [6 months after injection]
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.
- Visual Field Test [1 week after injection]
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
- Visual Field Test [1 month after injection]
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
- Visual Field Test [3 months after injection]
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
- Visual Field Test [6 months after injection]
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
- Funduscopy [1 week after injection]
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.
- Funduscopy [1 month after injection]
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.
- Funduscopy [3 months after injection]
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.
- Funduscopy [6 months after injection]
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.
- Electrorectinography [1 week after injection]
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.
- Electrorectinography [1 month after injection]
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.
- Electrorectinography [3 months after injection]
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.
- Electrorectinography [6 months after injection]
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.
- Optical Coherence Tomography (OCT) [1 week after injection]
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.
- Optical Coherence Tomography (OCT) [1 month after injection]
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.
- Optical Coherence Tomography (OCT) [3 months after injection]
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.
- Optical Coherence Tomography (OCT) [6 months after injection]
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.
Secondary Outcome Measures
- Patients Quality of Life [1 week after injection]
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
- Patients Quality of Life [1 month after injection]
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
- Patients Quality of Life [3 months after injection]
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
- Patients Quality of Life [6 months after injection]
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
- Pain evaluation [6 months after injection]
Evaluation on level of pain felt by patients
- Eye bump [6 months after injection]
Evaluation on appearance of eye bump
Eligibility Criteria
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- PT. Prodia Stem Cell Indonesia
Investigators
- Principal Investigator: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD, Gadjah Mada University, Faculty of Medicine
- Study Chair: dr. Cosmos O Mangunsong, Sp.M, Jakarta Eye Center
- Study Chair: dr. Rifa Widyaningrum, M.Sc, PhD, Sardjito Hospital
- Study Chair: Rima Haifa, S.Si, Prodia StemCell Indonesia
- Study Chair: Marsya N Kirana, S.T., M.Sc, Prodia StemCell Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT/RP/06/2022