Efficacy and Safety of FF-31501 in Meniscus Tear Patients

NCT05777967 | Unknown Phase 3

• 1 other identifier: FF31501JP301
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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 .

Conditions

Meniscus Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Arthroscopic assessment of the meniscus

  Meniscus repair up to 52 weeks

• Knee injury and osteoarthritis outcome score (KOOS)

  Screening up to the Day before injection,4,12,24 and 52 weeks

• Numerical Rating Scale (NRS)

  Screening up to the Day before injection,4,12,24 and 52 weeks

• Kellgren Lawrence

  Screening up to 24 and 52 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Biological: human autologous synovial stem cells

Interventions

human autologous synovial stem cells BIOLOGICAL

A single injection of 1.5 to 9.0 x 10\^7 human autologous synovial stem cells under arthroscopy

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• FUJIFILM Toyama Chemical Co., Ltd.: lead

Study Sites (4)

Medical corporation keimeikai Juko Osu hospital

Aichi, Japan

Location

Wakamatsu Hospital of the University of OccupationalOC and Environmental Health

Fukuoka, Japan

Location

Mie Prefectural General Medical Center

Mie, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 21, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

JP (4)