Efficacy and Safety of FF-31501 in Meniscus Tear Patients

Meniscus Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05777967
• Other study ID #: FF31501JP301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: FUJIFILM Toyama Chemical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 31, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Injury

Intervention

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

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
FUJIFILM Toyama Chemical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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