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

NCT ID: NCT07129694

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2027-11-30

Brief Summary

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

Detailed 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.

Conditions

Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Safety evaluation cohort; CT-ACL001 treatment group

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

Group Type: EXPERIMENTAL

Anterior cruciate ligament reconstruction

Intervention Type: DEVICE

Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.

Randomization cohort; CT-ACL001 treatment group

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

Group Type: EXPERIMENTAL

Anterior cruciate ligament reconstruction

Intervention Type: DEVICE

Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.

Randomization cohort; autologous tendon treatment group

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

Group Type: ACTIVE_COMPARATOR

Anterior cruciate ligament reconstruction

Intervention Type: PROCEDURE

Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.

Interventions

Anterior cruciate ligament reconstruction

Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.

Intervention Type: DEVICE

Anterior cruciate ligament reconstruction

Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Agency for Medical Research and Development

OTHER_GOV

Sponsor Role: collaborator

Mediscience Planning, Inc.

INDUSTRY

Sponsor Role: collaborator

CoreTissue BioEngineering Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

jRCT2032240214

Identifier Type: OTHER

Identifier Source: secondary_id

CT-ACL001

Identifier Type: -

Identifier Source: org_study_id