A multi-center, Open-label, Phase I trial to assess the safety for treatment of autologous chondrocytes implantation with CartiLife for patients with chondral defects in the knee

MCTT0 个研究点目标入组 6 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1)Adult males and females aged over 19
•2)Defect size: 2 to 10 ? on the unilateral knee cartilage (up to 4 ? in volume)
•3)Defect: isolated ICRS grade III or IV single defect chondral lesion on articular cartilage
•4)The joint space is maintained over 50% relative to baseline
•5)Patients with self-reliant behavior
•6)Patients understand strict rehabilitation protocol and follow-up program and are willing to follow it.
•7)Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial

•1)Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
•2)Patients with arthritis associated with autoimmune diseases
•3)Patients hypersensitive to bovine protein
•4)Patients with Haemophilia or markedly reduced immune function
•5)Patients hypersensitive to antibiotics like gentamicin
•6)Patients with arterial bleeding and severe venous bleeding
•7)Patients with other diseases including tumors except for cartilaginous defects of joints
•8)Patients with a history of radiation treatment and chemotherapy within the past two years
•9)Patients who are pregnant, nursing a baby or likely to get pregnant
•10)Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
•11)The other cases of patients which doctors determine not participate in the trial

发起方

MCTT