Loading clinical trials...

Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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

A Randomized, Multicenter Study Comparing the Safety and Efficacy of CT-ACL001, a Regenerative Ligament, With Standard Treatment in Anterior Cruciate Ligament Reconstruction

NCT07129694•CoreTissue BioEngineering Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 44 years

Sex

ALL

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).
+4 more criteria

Locations (6)

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

Key Dates

Start Date

November 25, 2024

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2027

Last Updated

September 30, 2025

Enrollment

ESTIMATED participants

Conditions

Anterior Cruciate Ligament Rupture

Interventions

Anterior cruciate ligament reconstruction

DEVICE

Anterior cruciate ligament reconstruction

PROCEDURE

Investigation of the Effects of Proprioceptive Exercises After Anterior Cruciate Ligament Surgery

NCT07333092

Anterior Cruciate Ligament InjuriesAnterior Cruciate Ligament Rupture

View study

RECRUITINGNA

Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures

NCT07023653

Anterior Cruciate Ligament Rupture

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Proprioceptive Exercises After Anterior Cruciate Ligament Surgery

Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures

Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport

Vitamin D to Improve Quadricep Muscle Strength

Anterior Cruciate Ligament Reconstruction With a Periosteal - Patellar Tendon - Bone Autograft - The Kocabey Press-Fit Technique

Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study