Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect

Inclusion Criteria

• •Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
• •Male or female patients at least 18 years of age
• •Patients whose lesion (unilateral joint) is 2 ㎠ \~ 9㎠ in size
• •Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
• •Patients with pain in affected joint of 60-mm or below on a 100-mm VAS (visual analogue scale)
• •Patients with adequate blood coagulation activity: PT(INR) \< 1.5, APTT \<1.5×control
• •Patients with adequate renal function: Creatinine ≤ 2.0 ㎎/㎗, levels of proteinuria measured with Dipstick: trace or less
• •Patients with adequate hepatic function: Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
• •Patients who have received no surgery or radiation therapy in the affected joint within the past 6 six weeks, and have recovered from the side effects of such past treatments
• •Female patients of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study
• •Patients whose physical examination results show no ligament instability of Grade II or above (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: \>10 mm)
• •Patients who voluntarily agreed to enroll in the study and signed an informed consent form