Efficacy and Safety of FF-31501 in Meniscus Tear Patients

Study Overview
=================
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 .

Official Title
-----------------
A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients

Conditions
-----------------
Meniscus Injury

Intervention / Treatment
-----------------
* Biological: human autologous synovial stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 |