KCT0004936进行中（未招募）未知
Clinical trial to evaluate the efficacy and safety of MegaCarti® ; cartilage defect treatment assisting cartilage regeneration in Knee Cartilage Defects : Multicenter, independent evaluator subject blinded, microfracture comparative, superiority, randomized, confirmatory clinical study and 5 years follow up study
&C BIO0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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) 19 years to 65 years
- •2) Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
- •3) Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
- •4) Patients whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms
- •5) knee cartilage defect size : Below 10 ?
排除标准
- •1) Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
- •2) Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
- •3) When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
- •4) When screening, Patients who took oral steroid within 1 month
- •5) When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
- •6) Patients taking immunosuppressive drug, or having immune disorder
- •7) Patients who can’t take MRI scan
- •8) Patients with a history of cancer within the past five years
- •9) Patients who have chronic renal failure, active hepatitis, or poor blood sugar control
- •10) BMI index : 30kg/m2 or over
- •11) Patients who have gout or gout history in the knee
- •12) When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
- •13) Drug and alcohol addiction / dependence or mental disorder
- •14) Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin)
- •15) Patients who have systemic or localized knee infection
- •16) Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
- •17) Patients who participated in other clinical trials within three months before screening
研究者
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