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

Launched by CORETISSUE BIOENGINEERING INC. · Aug 15, 2025

Keywords

ClinConnect Summary

This is a randomized, multicenter study in people with ACL injuries that require surgical reconstruction. It compares a new regenerative ligament device (CT-ACL001) with the standard reconstruction that uses the patient’s own tendon (autologous graft). Adults aged 18 to 44 years who need ACL reconstruction may be eligible, as long as they don’t have certain exclusions such as a very old or complicated knee injury, previous knee surgery on the same knee, severe problems in the other knee, active infection, or other serious conditions. The study plans about 64 participants across several Japanese hospitals.

If you enroll, you would be randomly assigned to either the CT-ACL001 device or the standard grafting method, with neither you nor the outcome assessors knowing which treatment you received. The main goal is to see whether the CT-ACL001 option works at least as well as the standard treatment, measured about 12 months after surgery using a knee function score (IKDC) where higher scores mean better function. Researchers will also track knee movement and stability, leg strength, any need for additional surgery, graft integrity on MRI, joint swelling, donor-site issues (for those getting autografts), activity level, and overall safety for up to two years. The trial is currently enrolling and is being conducted at multiple centers in Japan.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18 years old or older and under 45 years old.
• • Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.
• 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.