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

NCT07129694 | Enrolling By Invitation DMC

• 2 other identifiers: CT-ACL001jRCT2032240214
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 6

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

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior cruciate ligament reconstruction; Biological medical device; Regenerative ligament

Outcome Measures

Primary Outcomes (1)

• Evaluation of IKDC Subjective Score using a dedicated evaluation form

  The non-inferiority of the test device group to the control group will be evaluated 12 months after surgery using the IKDC Subjective Score. (maximum score: 100 and minimum score: 0, higher scores mean a better outcome)

  12 months after surgery

Secondary Outcomes (8)

• Measurement of Tibial Anterior Translation using a measuring device

  12 months after surgery

• Evaluation of Donor Site Morbidity using a dedicated evaluation form

  1 week, 1 month, 3 months and 6 months after surgery

• Measurement of Knee Flexion Strength using a measuring device

  3 months, 6 months and 12 months after surgery

• Evaluation of TEGNER-Activity-Score using a dedicated evaluation form

  6 months and 12 months after surgery

• Incidence of additional surgery on the affected side

  Through 12 months after surgery

Other Outcomes (8)

• Thigh Circumference

  1 week and 2weeks after surgery

• Surgery time

  At index procedure

• Evaluation of IKDC Subjective Score using a dedicated evaluation form

  24 months after surgery

Study Arms (3)

Safety evaluation cohort; CT-ACL001 treatment group

EXPERIMENTAL

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

Device: Anterior cruciate ligament reconstruction

Randomization cohort; CT-ACL001 treatment group

EXPERIMENTAL

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

Device: Anterior cruciate ligament reconstruction

Randomization cohort; autologous tendon treatment group

ACTIVE COMPARATOR

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

Procedure: Anterior cruciate ligament reconstruction

Interventions

Anterior cruciate ligament reconstruction 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; Safety evaluation cohort; CT-ACL001 treatment group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CoreTissue BioEngineering Inc.: lead
• Japan Agency for Medical Research and Development: collaborator
• Mediscience Planning, Inc.: collaborator

Study Sites (6)

Hirosaki University Hospital

Hirosaki, Aomori, 036-8563, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-0033, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: August 19, 2025
• Study Start: November 25, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

JP (6)