Meniscus InjuryPhase 3NCT05777967
Efficacy and Safety of FF-31501 in Meniscus Tear Patients
A Phase 3 study testing human autologous synovial stem cells in people with Meniscus Injury, run by FUJIFILM Toyama Chemical Co., Ltd. at 4 sites in Japan.
Trial summary
A single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Injury
- What is being tested?
- human autologous synovial stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesJapan
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected meniscal flap tear
- Patients with knee pain
- Patients with one or more of the following symptoms
- Feeling stuck in the knee・Instability of the knee
- Knee range of motion impairment
- Knee joint edema
- Other
Who cannot join
- Patients with poor knee alignment
- Patients who underwent meniscus surgery or platelet rich plasma therapy
- Patients with or history of knee ligament injury
- Diabetic patients with poor glycemic control
- Patients with the following complications and poor general condition
- Severe cardiovascular disease
Show all 12Show fewer
- Severe liver disease
- Severe renal dysfunction
- Severe anemia・uncontrolled mental illness
- Other diseases for which sudden change or worsening of symptoms can be expected during study participation
- Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
- Other
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Medical corporation keimeikai Juko Osu hospital
Aichi
Wakamatsu Hospital of the University of OccupationalOC and Environmental Health
Fukuoka
Mie Prefectural General Medical Center
Mie
Tokyo Medical and Dental University Hospital
Tokyo
About this study
Official title: A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
A single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .
- Conditions
- Meniscus Injury
- Being tested
- human autologous synovial stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human autologous synovial stem cellsBiological
A single injection of 1.5 to 9.0 x 10^7 human autologous synovial stem cells under arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Biological: human autologous synovial stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score
It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively.
Measured: Screening up to 52 weeks
Secondary outcomes (4)
Arthroscopic assessment of the meniscus
The structure and function of the repaired meniscus will be assessed in terms of the presence, stability, and smoothness of the meniscus by arthroscopic imaging and MRI.
Measured: Meniscus repair up to 52 weeks
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS consists of five subscales; Pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec) and knee related quality of life (QOL). Lowest and highest scores are 0 and 100 (better), respectively.
Measured: Screening up to the Day before injection,4,12,24 and 52 weeks
Numerical Rating Scale (NRS)
NRS consists of an 11-point scale to evaluate current knee pain where no pain is indicated by '0', and the worst pain imaginable by '10'.
Measured: Screening up to the Day before injection,4,12,24 and 52 weeks
Kellgren Lawrence
The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades.
Measured: Screening up to 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus InjuryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777967
- Sponsor's protocol ID
- FF31501JP301
- Status last verified
- Jan 2024
- First submitted
- 8 Feb 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
- ClinicalTrials.gov ID
- NCT05777967
- Acronym / sponsor ID
- FF31501JP301
- Conditions
- Meniscus Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2023 (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 single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: human autologous synovial stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with suspected meniscal flap tear
- Patients with knee pain
- Patients with one or more of the following symptoms
- Other
Key exclusion criteria (12 listed)
- Patients with poor knee alignment
- Patients who underwent meniscus surgery or platelet rich plasma therapy
- Patients with or history of knee ligament injury
- Diabetic patients with poor glycemic control
- Patients with the following complications and poor general condition
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 |
|---|---|---|
| human autologous synovial stem cellsA single injection of 1.5 to 9.0 x 10^7 human autologous synovial stem cells under arthroscopy | Biological | Single Arm |
Primary outcome
Lysholm score
Time frame: Screening up to 52 weeks
It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively.
4 secondary outcomes
Arthroscopic assessment of the meniscus
Time frame: Meniscus repair up to 52 weeks
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: Screening up to the Day before injection,4,12,24 and 52 weeks
Numerical Rating Scale (NRS)
Time frame: Screening up to the Day before injection,4,12,24 and 52 weeks
Kellgren Lawrence
Time frame: Screening up to 24 and 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing human autologous synovial stem cells in people with Meniscus Injury, run by FUJIFILM Toyama Chemical Co., Ltd. at 4 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Lysholm score (time frame: Screening up to 52 weeks). 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 2 Feb 2024.