NCT05777967Active, not recruitingPhase 3
A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
FUJIFILM Toyama Chemical Co., Ltd.4 sites in 1 country18 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- Lysholm score
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Single Arm
Experimental
Intervention: human autologous synovial stem cells (Biological)
Outcomes
Primary Outcomes
Lysholm score
Time Frame: Screening up to 52 weeks
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.
Secondary Outcomes
- Kellgren Lawrence(Screening up to 24 and 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)
- Arthroscopic assessment of the meniscus(Meniscus repair up to 52 weeks)
Investigators
Study Sites (4)
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