A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle for 18 Months
试验速览
- 阶段
- 3 期
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months
详细描述
This is an open label trial, involving a total of 28 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 6* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, x-ray, MRI tests and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 5 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and women over 15 and less than 65 years of age
- •Applicable to patients who have a partial cartilage defect in their ankle based on an MRI (defect size: for a single lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2)
- •Patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance
- •Patients which surrounding cartilage are normal 5.Patients with a Grade III or IV cartilage defect size on the ICRS (International Cartilage Repair Society)
- •Patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form
排除标准
- •Patients hypersensitive to bovine protein
- •Patients hypersensitive to gentamicin antibiotics
- •Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
- •Patients with arthritis related to autoimmune disease
- •Pregnant, breast-feeding patients or those who have a possibility of pregnancy
- •Patients with accompanying diseases other than articular cartilage defects, including tumors
- •Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
- •Patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
- •Patients who are administering antibiotics and antimicrobial agents due to infection
- •Patients who receive steroid hormone therapy
- •Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
研究组 & 干预措施
Autologous cultured Chondrocyte
Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.
干预措施: CHONDRON (Drug)
结局指标
主要结局
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
时间窗: 12 months after the surgery
The change of ICRS grade of the affected ankle shall be assessed at 12 months after the surgery. The results on the surgery date shall be considered the baseline data and shall be compared with those at 12 months after the surgery based on arthroscopy. For the final efficacy evaluation, the percentage of the patients (success rate) who showed Grade III or IV ICRS before the surgery and improved to Grade 0 or I after the surgery will be calculated.
次要结局
- Score change of AOFAS(American orthopedic foot & ankle society) Score(baseline and six, 12 and 18 months after the surgery)
- Hannover Score(baseline and six, 12 and 18 months after the surgery)
- Score change of Evaluation by physician in charge(six, 12 and 18 months after the surgery)
- Score change of 100mmVAS(visual analogue scale)(baseline and six, 12 and 18 months after the surgery)
- Comparing MRI results(baseline and 18 months after the surgery)