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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05777967 on ClinicalTrials.gov