Efficacy and Safety of FF-31501 in Meniscus Tear Patients

Phase 3

Active, not recruiting

• Conditions: Meniscus Injury
• Interventions: Biological: human autologous synovial stem cells

• Registration Number: NCT05777967
• Lead Sponsor: FUJIFILM Toyama Chemical Co., Ltd.

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-12
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Patients with suspected meniscal 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	human autologous synovial stem cells	-

Primary Outcome Measures

Name	Time	Method
Lysholm score	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.

Secondary Outcome Measures

Name	Time	Method
Knee injury and osteoarthritis outcome score (KOOS)	Screening up to the Day before injection,4,12,24 and 52 weeks	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.
Numerical Rating Scale (NRS)	Screening up to the Day before injection,4,12,24 and 52 weeks	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'.
Arthroscopic assessment of the meniscus	Meniscus repair up to 52 weeks	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.
Kellgren Lawrence	Screening up to 24 and 52 weeks	The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades.

Trial Locations

Locations (4)

Tokyo Medical and Dental University Hospital; 🇯🇵 Tokyo, Japan

Mie Prefectural General Medical Center; 🇯🇵 Mie, Japan

Medical corporation keimeikai Juko Osu hospital; 🇯🇵 Aichi, Japan

Wakamatsu Hospital of the University of OccupationalOC and Environmental Health; 🇯🇵 Fukuoka, Japan