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A Phase 3study of FF-31501 in meniscus tear patients

A Phase 3 single-arm multicenter study of FF-31501 in meniscus tear patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2073220083
Enrollment
18
Registered
2023-01-04
Start date
2023-01-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniscus injuries indicated for meniscectomy

Interventions

A single injection of human autologous synovial stem cells under arthroscopy

Sponsors

Sakurai Tsutomu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with suspected meniscus flap tear 2.Patients with knee pain 3.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 4.Other

Exclusion criteria

Exclusion criteria: 1.Patients with poor knee alignment 2.Patients who underwent meniscus surgery or platelet rich plasma therapy 3.Patients with or history of knee ligament injury 4.Diabetic patients with poor glycemic control 5.Patients with the following complications and poor general condition Severe cardiovascular disease 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 6.Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period 7.Other

Design outcomes

Primary

MeasureTime frame
Changes in Lysholm score after injection

Secondary

MeasureTime frame
Arthroscopic assesment of the meniscus before and 52 weeks after injection of FF-31501 Changes in KOOS after injection Changes in NRS after injection

Contacts

Public ContactOfficer Clinical Trial Information

FUJIFILM Toyama Chemical Co., Ltd

fftc-clinicaltrial-info1@fujifilm.com+81-3-6228-3129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026