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

CoreTissue BioEngineering Inc.

Status: Invitation-only

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Procedure: Anterior cruciate ligament reconstruction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07129694

jRCT2032240214 (Other Identifier)

CT-ACL001

Details and patient eligibility

About

A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction

Full description

The study will target patients (18 years old or older and under 45 years old) who have suffered anterior cruciate ligament injuries that require reconstruction surgery, and will evaluate the safety and efficacy of the investigational device when used in reconstruction surgery, using patients who used autologous tendons (knee flexor tendons) as a comparison control.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups

Safety evaluation cohort; CT-ACL001 treatment group

Experimental group

Description:

An acute safety evaluation group that will receive treatment with the test device without randomization: 7 cases

Randomization cohort; CT-ACL001 treatment group

Experimental group

Description:

Treatment with the test device (test device group): 38 cases

Randomization cohort; autologous tendon treatment group

Active Comparator group

Description:

Anterior cruciate ligament reconstruction with autologous tendon (knee flexor tendon) (control group): 19 cases

Treatment:

Procedure: Anterior cruciate ligament reconstruction

Procedure: Anterior cruciate ligament reconstruction