Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Funduscopy
研究概览
简要总结
The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
详细描述
The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) preparations are suspended in Conditioned Medium (CM) until it reaches a 2 ml volume of cell suspension. Two dosages will be prepared, 1.5 million and 5 million of UC-MSC. Stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased 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 observations will be written in the table and analyzed by a statistic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Visus more than 20/100
- •Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
- •Visual field equivalent diameter more than 10o
- •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 tumors
- •Under 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
EYESTEM 001-X
1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar.
干预措施: 1.5 x 10^6 UC-MSC + CM (Biological)
EYESTEM 001-XF
1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar.
干预措施: 5 x 10^6 UC-MSC + CM (Biological)
结局指标
主要结局
Funduscopy
时间窗: 6 months 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.
Incident of Adverse Events
时间窗: 1 week after injection
assessment of infection, inflammation, eye pressure and patients complaints
Frequency of Adverse Events
时间窗: 1 week after injection
assessment of infection, inflammation, eye pressure and patients complaints
Visual Field Test
时间窗: 6 months after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Visual Acuity Test
时间窗: 6 months 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.
Electrorectinography
时间窗: 6 months 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: 6 months 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.
Incident of Adverse Events
时间窗: 1 day after injection
assessment of infection, inflammation, eye pressure and patients complaints
Frequency of Adverse Events
时间窗: 1 day after injection
assessment of infection, inflammation, eye pressure and patients complaints
Visual Acuity Test
时间窗: 1 week 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 Acuity Test
时间窗: 1 month 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 Acuity Test
时间窗: 3 months 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: 1 week after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Visual Field Test
时间窗: 1 month after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Visual Field Test
时间窗: 3 months after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.
Funduscopy
时间窗: 1 week 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.
Funduscopy
时间窗: 1 month 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.
Funduscopy
时间窗: 3 months 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: 1 week 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.
Electrorectinography
时间窗: 1 month 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.
Electrorectinography
时间窗: 3 months 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: 1 week 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.
Optical Coherence Tomography (OCT)
时间窗: 1 month 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.
Optical Coherence Tomography (OCT)
时间窗: 3 months 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.
次要结局
- Eye bump(6 months after injection)
- Pain evaluation(6 months after injection)
- Patients Quality of Life(6 months after injection)
- Patients Quality of Life(1 week after injection)
- Patients Quality of Life(1 month after injection)
- Patients Quality of Life(3 months after injection)