Last reviewed · How we verify
A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
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 .
Details
| Lead sponsor | FUJIFILM Toyama Chemical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 18 |
| Start date | 2023-01-01 |
| Completion | 2025-12-31 |
Conditions
- Meniscus Injury
Interventions
- human autologous synovial stem cells
Primary outcomes
- Lysholm score — 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.
Countries
Japan