A Phase 3study of FF-31501 in meniscus tear patients

JRCT ID: jRCT2073220083

Registered date:04/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Meniscus injuries indicated for meniscectomy
• Date of first enrollment: 24/01/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): A single injection of human autologous synovial stem cells under arthroscopy

Outcome(s)

• Primary Outcome: Changes in Lysholm score after injection

Secondary Outcome

Arthroscopic assesment of the meniscus before and 52 weeks after injection of FF-31501
Changes in KOOS after injection
Changes in NRS after injection

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients with suspected meniscus 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

Exclude 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

Related Information

• Primary Sponsor: Sakurai Tsutomu