ChiCTR-OPC-14005353进行中（未招募）治疗新技术临床试验
臨床試驗研究 –「自體間質幹細胞治療腕關節軟骨缺損」
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Diagnostic radiological (MRI)assessments will be done at post-injection 6th month.
研究概览
简要总结
自體間質幹細胞治療腕關節軟骨缺損
研究设计
- 研究类型
- 观察性研究
- 主要目的
- 单臂
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Wrist pain of mechanical origin(post-traumatic);
- •The pain cannot be relieved by treating other underlying defects other than carpal affections;
- •Patients with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects;
- •Absence of any local or general infection;
- •Hematologic and biochemical analyses with no significant alterations that contraindicate intervention;
- •Patient who is able to understand the nature the study and provide informed written consent.
排除标准
- •Age older than 75 or younger than 18 years old or legally dependent;
- •Patients with past history of hematologic disorders;
- •Signs of infection or positive serology for HIV, HBV, HCV, or syphilis;
- •Congenital or acquired diseases leading to significant wrist deformities that may interfere with cell application or interpretation of results;
- •Pregnancy or breast, feeding, Neoplasia, Immunosuppression, Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study;
- •Patients with alcoholism/drug abuse;
- •Other medical conditions that may discourage participation in the study.
研究组 & 干预措施
Case series
Autologous mesenchymal stem cell intra-articular injection
结局指标
主要结局
Diagnostic radiological (MRI)assessments will be done at post-injection 6th month.
次要结局
- VAS, functional wrist score, PRWE, DASH, Power, ROM at post-injection 3rd, 6th, 12nd and 24th month
研究者
研究点 (1)
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