Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 主要终点
- Unexplained local and systemic symptoms or death
研究概览
简要总结
The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA
详细描述
This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10^7cells/3mL, and the dose in the low dose group is 1×10^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -
排除标准
- •① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.-
研究组 & 干预措施
low dose of mesenchymal stem cells
Three groups of patients were enrolled in this study. Every group includes three patients. The three groups of patients were treated with high, medium and low dose of cytokine.The low-dose is 1 × 10^7cells / 3mL
干预措施: mesenchymal stem cells (Drug)
high dose of mesenchymal stem cells
the high dose is 1 × 10^8cells / 3mL
干预措施: mesenchymal stem cells (Drug)
medium dose of mesenchymal stem cells
the medium-dose is 5 × 10^7cells / 3mL
干预措施: mesenchymal stem cells (Drug)
结局指标
主要结局
Unexplained local and systemic symptoms or death
时间窗: 6 months
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
次要结局
未报告次要终点
研究者
yangziyi
arthritis clinic and research center
Peking University People's Hospital