Treatment of Patients With Segmental Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percent of completely recovered patients with segmental bone tissue defects
研究概览
简要总结
Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles
详细描述
The aims of the project are to develop a technology for obtaining mesenchymal stem cells extracellular vesicles; to develop biomedical cell product based on mesenchymal stem cells enriched with own extracellular vesicles; to conduct the clinical trials of the biomedical cell product in the treatment of patients with segmental bone tissue defects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-50 years;
- •non-union fractures of the tubular bones of the upper limb;
- •segmental defects of the bone tissue of the tubular bones of the upper limbs;
- •absence of severe comorbidity worsening the patient's prognosis.
排除标准
- •pregnancy;
- •acute inflammatory processes;
- •viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections;
- •autoimmune diseases;
- •allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
- •mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction;
- •patients with malignant tumors including a history.
结局指标
主要结局
Percent of completely recovered patients with segmental bone tissue defects
时间窗: 1 year
Percent of completely recovered patients with segmental bone tissue defects
Adverse effects associated with the therapy
时间窗: 1 month
Determination of adverse effects associated with the therapy
次要结局
未报告次要终点