Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Visual Acuity Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnant or nursing women
- •Positive result of HIV test
- •Have a history of eye tumours
- •In the 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)
研究组 & 干预措施
Conditioned Medium (CM)
2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar
干预措施: Conditioned Medium (CM) (Biological)
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
干预措施: Umbilical Cord Mesenchymal Stem Cell (UC-MSC) (Biological)
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
干预措施: Conditioned Medium (CM) (Biological)
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
干预措施: Umbilical Cord Mesenchymal Stem Cell (UC-MSC) (Biological)
结局指标
主要结局
Visual Acuity Test
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 5 years after injection
a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
次要结局
未报告次要终点