Trials / Unknown
UnknownNCT05777967
Efficacy and Safety of FF-31501 in Meniscus Tear Patients
A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- FUJIFILM Toyama Chemical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-12-01
- Completion
- 2025-12-31
- First posted
- 2023-03-21
- Last updated
- 2024-02-02
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05777967. Inclusion in this directory is not an endorsement.