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New ligament could replace torn ACL without using your own tissue

NCT ID NCT07129694

Disease control Sponsor: CoreTissue BioEngineering Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new regenerative ligament (CT-ACL001) for repairing a torn ACL, compared to the standard surgery. About 64 people aged 18-45 with a recent ACL injury will take part. The goal is to see if the new ligament works as well as the standard treatment and causes fewer problems at the donor site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 44 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anterior cruciate ligament rupture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563, Japan

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-0033, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666, Japan

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