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The study will perform to follow-up UC-MSCs and CM transplantation. 18 patients will be called back to be examined after 5 years of UC-MSC and/or CM transplantation.
The study will be performed on 18 patients who received UC-MSC and CM transplantation in 2018. The study is included as retrospective cohort since the transplantation happened 5 years ago. 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.The study will be performed at Rumah Sakit Jakarta Eye Center and Rumah Sakit Umum Pusat Dr. Sardjito Yogyakarta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conditioned Medium (CM) | 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar |
| |
| UC-MSC + NaCl | 1.8 ml cell preparations are suspended in physiological NaCl until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension injected into peribulbar |
| |
| UC-MSC+CM | 1.8 ml cell preparations are suspended in Conditioned Medium (CM) until it reaches a total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) + Conditioned Medium (CM) suspension injected into peribulbar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conditioned Medium (CM) | Biological | Conditioned Medium (CM) 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. | 5 years 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. | 5 years 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. | 5 yeas 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. | 5 years 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 | 5 years after injection |
| Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 5 years after injection |
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Inclusion Criteria:
Exclusion Criteria:
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Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD | Contact | +62 811-293-476 | mb.sasongko@ugm.ac.id | |
| Dr. Cynthia R Sartika, M.Si | Contact | cynthia.sartika@prostem.co.id |
| Name | Affiliation | Role |
|---|---|---|
| dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD | Gadjah Mada University, Faculty of Medicine | Principal Investigator |
| dr Cosmos O Mangunsong, Sp.M | Jakarta Eye Center | Study Director |
| 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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| Umbilical Cord Mesenchymal Stem Cell (UC-MSC) | Biological | Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar |
|
| 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 Chair |
| Yogyakarta |
| Special Region |
| 55284 |
| Indonesia |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004864 | Equipment and Supplies |