Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR

Exclusion Criteria

• •Chronic anterior cruciate ligament injury (injury occurred more than 12 months ago).
• •History of knee surgery, including anterior cruciate ligament surgery on the index side.
• •Complication or history cruciate ligament injury on the opposite side, history of total knee arthroplasty, osteotomy around the knee, or osteosynthesis around the knee on the opposite side.
• •Meniscus injury that requires extensive resection and is impossible to suture on the index side, collateral ligament injury or posterior cruciate ligament injury of 2° or more on the index side.
• •Complication of osteoarthritis of the knee on the index side, KL classification 2° or higher.
• •Complications of cartilage damage that cannot be treated by drilling or microfracture on the index side.
• •Patients with infection in the index knee or inflammatory joint disease such as rheumatoid arthritis.
• •Patients undergoing radiation therapy, chemotherapy, or both.
• •Patients currently receiving treatment with systemic steroids, immunosuppressants, or both.
• •Patients who are allergic to bovine products (e.g. meat).
• •Patients who cannot discontinue returning to sports until 9 months after reconstruction surgery.
• •Pregnant, breastfeeding and possibly pregnant patients.
• •Female patients of childbearing potential and male patients who cannot agree to contraception for at least one year after reconstruction surgery.
• •Patients who participated in other clinical trials within 4 weeks prior to reconstruction surgery.