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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conditioned Medium (CM) | Active Comparator | a total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar |
|
| UC-MSC + NaCl | Active Comparator | 1.8 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 Comparator | 1.8 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Mesenchymal Stem Cell (UC-MSC) | Biological | Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| dr Cosmos O Mangunsong, Sp.M | Gadjah Mada University, Faculty of Medicine | Principal Investigator |
| 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 Director |
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jakarta Eye Center Hospital | Jakarta | DKI Jakarta | Indonesia | |||
| Sardjito Hospital |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D017077 | Culture Media, Conditioned |
| ID | Term |
|---|---|
| D003470 | Culture Media |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Conditioned Medium (CM) | Biological | Conditioned Medium (CM) injected by peribulbar |
|
| 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 |
| Yogyakarta |
| Special Region |
| 55284 |
| Indonesia |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004864 | Equipment and Supplies |