Efficacy and Safety of FF-31501 in Meniscus Tear Patients

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 .

Study Overview

• Status: Active, not recruiting
• Conditions: Meniscus Injury
• Intervention / Treatment: Biological: human autologous synovial stem cells

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: FUJIFILM Toyama Chemical Co., Ltd; Phone Number: +81 3-6228-3129; Email: fftc-clinicaltrial-info1@fujifilm.com

Study Locations

• Japan
  • Aichi, Japan
    • Medical corporation keimeikai Juko Osu hospital
  • Fukuoka, Japan
    • Wakamatsu Hospital of the University of OccupationalOC and Environmental Health
  • Mie, Japan
    • Mie Prefectural General Medical Center
  • Tokyo, Japan
    • Tokyo Medical and Dental University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Biological: human autologous synovial stem cells; A single injection of 1.5 to 9.0 x 10^7 human autologous synovial stem cells under arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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'.	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.	Screening up to 24 and 52 weeks

Collaborators and Investigators

• Sponsor: FUJIFILM Toyama Chemical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FF31501JP301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No