JPRN-jRCTa030190242已完成2 期
The clinical study for the joint treatment by allogeneic cell sheet
Masato Sato0 个研究点目标入组 10 人开始时间: 2020年3月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
Ten participants were enrolled and received the combined surgeries of PD sheet transplantation and HTO. No serious adverse events were observed during the follow-up period up to 12 months after surgeries. KOOS and Lysholm Score at 12 months after surgeries were significantly improved respectively compared with those of preoperative status. These results indicated the safty and the efficacy of the treatment for the patients with osteoarthritis of the knee.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 60age old（—）
- 性别
- All
入选标准
- •Patients must meet all of the following criteria and have the ability to give informed consent
- •1. 20 to 60 years of age, either male or female
- •2. Have a cartilage defect of the knee joint
- •3. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III
- •4. The patellofemoral joint and condyle of the femur must have a cartilage defect or defects which can be fully covered by allogeneic chondrocyte sheets and which have traditionally been treated by marrow stimulation techniques or osteochondral autografts
排除标准
- •Patients who meet any one or more of the following criteria will be excluded
- •1. Obtaining informed consent from the patient is difficult
- •2. Having complications hindering surgery under general anesthesia or complications affecting knee surgery
- •3. Having problematic infectious disease (including testing positive for HBV, HCV, HIV, HTLV, FTA-ABS)
- •4. Having rheumatoid arthritis or other systemic inflammatory disease
研究者
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