Efficacy and Safety of FF-31501 in Meniscus Tear Patients

FUJIFILM Toyama Chemical Co., Ltd.18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meniscus Injury

Interventions

human autologous synovial stem cellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Medical corporation keimeikai Juko Osu hospital

Aichi, Japan

Wakamatsu Hospital of the University of OccupationalOC and Environmental Health

Fukuoka, Japan

Mie Prefectural General Medical Center

Mie, Japan

Tokyo Medical and Dental University Hospital

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: Screening up to 52 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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'.

Time frame: 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.

Time frame: Screening up to 24 and 52 weeks

Data from ClinicalTrials.gov

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