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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 25, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2027

Conditions
Anterior Cruciate Ligament Rupture
Interventions
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.

Trial Locations (6)

036-8563

Hirosaki University Hospital, Hirosaki

734-8551

Hiroshima University Hospital, Hiroshima

060-8648

Hokkaido University Hospital, Sapporo

650-0017

Kobe University Hospital, Kobe

113-0033

Juntendo University Hospital, Bunkyo-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

All Listed Sponsors
collaborator

Japan Agency for Medical Research and Development

OTHER_GOV

collaborator

Mediscience Planning, Inc.

INDUSTRY

lead

CoreTissue BioEngineering Inc.

INDUSTRY