KCT0005566尚未招募未知
A Pilot study to Evaluate the Efficacy and Safety of Autologous Adipose tissue-derived Stromal Vascular Fraction(SVF) treatment for the Patients with articular cartilage injury of the knee: A Single center, Single-arm, Prospective, investigator-initiated Pilot study
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Adults aged 19 to 65
- •2) Patients requiring Microfracture Surgery with articular cartilage lesions in the knee joint, and those with a Modified Outerbridge classification of Grade 3 or 4
- •3) Those whose joint cartilage lesions are 3cm2 or more in size
- •4) Those who participate in the clinical trial, observe treatment and procedures, and are willing to visit the hospital for all observational evaluation
- •5) A person who voluntarily signs a written consent after hearing the explanation of the purpose and method of this clinical trial
排除标准
- •1) Those who have already had the Microfracture Surgery or treatment at the treatment site
- •2) Those with a Body Mass Index (BMI) of higher than 35
- •3) Those who are pregnant or nursing, or who are of childbearing age, do not agree to maintain contraception during the clinical period
- •* Medically accepted contraceptive methods: condoms, oral contraceptives lasting for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives installed, etc.
- •4) Those who are expected to increase bleeding because they cannot stop taking antithrombotic drugs or anticoagulants before surgery
- •5) Those with malignant tumors or history of malignant tumors within 5 years
- •6) Those with diabetes with severe complications
- •7) Those who are judged that the dawn is short (terminal patient)
- •8) Those who cannot understand the purpose and method of the clinical trial
- •9) Those who participated in other medical device intervention clinical trials within 6 months before participating in this study (in the case of drug intervention clinical trials, those who participated within 30 days)
- •10) Others, those who are judged to be difficult to conduct this clinical trial by Investigator
研究者
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