NCT07129694

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: CoreTissue BioEngineering Inc. · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2025-08-19
• Last updated: 2025-09-30

Locations

6 sites across 1 country: Japan