Efficacy and Safety of FF-31501 in Meniscus Tear Patients
NCT05777967 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-02-02
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
- Meniscus Injury
Interventions
- 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
Sponsors & Collaborators
-
FUJIFILM Toyama Chemical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-01
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- Japan
Study Locations
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