Retinitis Pigmentosa Clinical Trial
— RPOfficial title:
Safety Issues of Peribulbar Injection of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) in Patients With Retinitis Pigmentosa
Verified date | March 2020 |
Source | PT. Prodia Stem Cell Indonesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | September 20, 2019 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Indonesia | Jakarta Eye Center Hospital | Jakarta | DKI Jakarta |
Indonesia | Sardjito Hospital | Yogyakarta | Special Region |
Lead Sponsor | Collaborator |
---|---|
PT. Prodia Stem Cell Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 1 week after injection | |
Primary | Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 1 month after injection | |
Primary | Angiography | a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina. | 3 months after injection |
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