Anterior Cruciate Ligament RuptureNCT07129694
Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR
A study testing Anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by CoreTissue BioEngineering Inc. at 6 sites in Japan.
Trial summary
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Anterior cruciate ligament reconstruction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesJapan
- Study dates
- 25 Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 years old or older and under 45 years old.
- Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Japan6 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-0033
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
About this study
Official title: A Randomized, Multicenter Study Comparing the Safety and Efficacy of CT-ACL001, a Regenerative Ligament, With Standard Treatment in Anterior Cruciate Ligament Reconstruction
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
Read the 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
- Being tested
- Anterior cruciate ligament reconstruction
- Keywords
- Anterior cruciate ligament reconstruction, Biological medical device, Regenerative ligament
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cruciate ligament reconstructionDevice
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.
Anterior cruciate ligament reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Anterior cruciate ligament reconstruction |
| Randomization cohort; CT-ACL001 treatment group | Experimental | Treatment with the test device (test device group): 38 cases Receives: 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 Receives: Procedure: Anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months after surgery
Secondary outcomes (8)
Measurement of Tibial Anterior Translation using a measuring device
Evaluate whether there is any significant difference in the amount of anterior tibial movement between the test device group and the comparison group 12 months after surgery.
Measured: 12 months after surgery
Evaluation of Donor Site Morbidity using a dedicated evaluation form
Donor site morbidity will be evaluated to determine whether the test device group is superior to the control group at 1 week, 1 month, 3 months, and 6 months after surgery.
(maximum score: 96 and minimum score: 0, higher scores mean a better outcome)
Measured: 1 week, 1 month, 3 months and 6 months after surgery
Measurement of Knee Flexion Strength using a measuring device
In knee flexion strength evaluation (isometric knee flexion strength ratio of affected side: affected side/healthy side (%)), evaluate whether the affected side ratio is greater in the test device group than in the control group at 3 months, 6 months, and 12 months after surgery.
Measured: 3 months, 6 months and 12 months after surgery
Evaluation of TEGNER-Activity-Score using a dedicated evaluation form
Evaluate whether there are any significant differences in TEGNER-Activity-Scores between the test group and the comparison group at 6 and 12 months after surgery.
(maximum score: 10 and minimum score: 0, higher scores mean a better outcome)
Measured: 6 months and 12 months after surgery
Incidence of additional surgery on the affected side
To evaluate whether there is a significant difference in the incidence (number) of additional surgeries on the affected side up to 12 months after surgery.
Measured: Through 12 months after surgery
Graft rupture rate
Evaluate using MRI (T1, T2) to determine whether there is a significant difference in the graft rupture rate between the test device group and the comparison group up to 12 months after surgery.
Measured: Through 12 months after surgery
Joint effusion
Evaluate whether there is any significant difference between the test device group and the comparison group in the incidence of joint effusion requiring puncture (1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery).
Measured: 1 month, 3 months and 6 months and 12 months after surgery
Adverse events/malfunction rates
Evaluate all adverse events and malfunctions that occur after IC has been obtained and during the clinical trial period.
Measured: Through 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start25 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoreTissue BioEngineering Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japan Agency for Medical Research and Development, Mediscience Planning, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129694
- Sponsor's protocol ID
- CT-ACL001
- Other IDs
- jRCT2032240214
- Status last verified
- Sep 2025
- First submitted
- 12 May 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Study Comparing the Safety and Efficacy of CT-ACL001, a Regenerative Ligament, With Standard Treatment in Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07129694
- Acronym / sponsor ID
- CT-ACL001
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior cruciate ligament reconstruction, Biological medical device, Regenerative ligament
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- CoreTissue BioEngineering Inc.Industry (pharma, biotech, devices)
- Collaborators
- Japan Agency for Medical Research and Development, Mediscience Planning, Inc.
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety evaluation cohort; CT-ACL001 treatment group | Experimental | Device: Anterior cruciate ligament reconstructionAn acute safety evaluation group that will receive treatment with the test device without randomization: 7 cases |
| Randomization cohort; CT-ACL001 treatment group | Experimental | Device: Anterior cruciate ligament reconstructionTreatment with the test device (test device group): 38 cases |
| Randomization cohort; autologous tendon treatment group | Active comparator | Procedure: Anterior cruciate ligament reconstructionAnterior cruciate ligament reconstruction with autologous tendon (knee flexor tendon) (control group): 19 cases |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18 years old or older and under 45 years old.
- Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior cruciate ligament reconstructionSingle-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. | Device | Randomization cohort; CT-ACL001 treatment group, Safety evaluation cohort; CT-ACL001 treatment group |
| Anterior cruciate ligament reconstructionSingle-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 or surgery | Randomization cohort; autologous tendon treatment group |
Primary outcome
Evaluation of IKDC Subjective Score using a dedicated evaluation form
Time frame: 12 months after surgery
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)
8 secondary outcomes
Measurement of Tibial Anterior Translation using a measuring device
Time frame: 12 months after surgery
Evaluation of Donor Site Morbidity using a dedicated evaluation form
Time frame: 1 week, 1 month, 3 months and 6 months after surgery
Measurement of Knee Flexion Strength using a measuring device
Time frame: 3 months, 6 months and 12 months after surgery
Evaluation of TEGNER-Activity-Score using a dedicated evaluation form
Time frame: 6 months and 12 months after surgery
Incidence of additional surgery on the affected side
Time frame: Through 12 months after surgery
Graft rupture rate
Time frame: Through 12 months after surgery
Joint effusion
Time frame: 1 month, 3 months and 6 months and 12 months after surgery
Adverse events/malfunction rates
Time frame: Through 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by CoreTissue BioEngineering Inc. at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of IKDC Subjective Score using a dedicated evaluation form (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.