NCT03839238Unknown1 期
Safety Observation on Human Embryonic Stem Cell (hESC) Derived Mesenchymal Stem Cells(MSC) Like Cell for the Meniscus Injury
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
研究概览
简要总结
human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury
详细描述
Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Grade Ⅰ-Ⅱ meniscus injury of knee joint
- •The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment
排除标准
- •Recent history of lower limb fractures or intra-articular drug injection
- •The patients who have meniscus injury of knee joint need the surgical repair
- •The patients who have the severe coagulation disorders, cardiopulmonary failure and so on
- •The women who are pregnant or nursing
- •There are electronic implants such as pacemakers in the body
- •The patients who are infected the HIV, the virus of hepatitis or syphilis
- •The patients who are alcoholism or drug user
- •The patients who have vestibular and balance disorders
- •The patients with severe cognitive impairment who cannot follow instructions to complete the treatment
- •The patients who don't sign the informed consent
- •The patients who have tumor
- •Immunodeficiency patients
- •The patients who have congenital or acquired knee malformation
- •Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials
研究组 & 干预措施
Meniscus Injured patients
Experimental
hESC Derived MSC Like Cell
干预措施: hESC derived MSC like cell (Biological)
结局指标
主要结局
The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
时间窗: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia
次要结局
- Range of knee motion(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
- Lysholm Knee Scale(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
- MRI of knee(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
- Global posture analysis system(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
- Dynamic balance test(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
- Ultrasound of knee joint(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
- Visual Analog Score for pain（VAS）(baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell)
研究者
研究点 (1)
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