Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Conditioned Medium (CM) 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar |
Biological: Conditioned Medium (CM)
Conditioned Medium (CM) injected by 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 |
Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by 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 |
Biological: Conditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar
Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity Test [5 years 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 [5 years after injection]
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.
- Funduscopy [5 yeas 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 [5 years 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) [5 years 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
- Angiography [5 years after injection]
a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Visual field defects at the initial examination with Humphrey perimetry are between 25% to 50%
-
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
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Positive result of HIV test
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Have a history of eye tumours
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In the immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
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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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jakarta Eye Center Hospital | Jakarta | DKI Jakarta | Indonesia | |
| 2 | Sardjito Hospital | Yogyakarta | Special Region | Indonesia | 55284 |
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 Director: 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/08/2022