Efficacy and Safety of FF-31501 in Meniscus Tear Patients

NCT ID: NCT05777967

Last Updated: 2024-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Meniscus Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

human autologous synovial stem cells

Intervention Type BIOLOGICAL

A single injection of 1.5 to 9.0 x 10\^7 human autologous synovial stem cells under arthroscopy

Interventions

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human autologous synovial stem cells

A single injection of 1.5 to 9.0 x 10\^7 human autologous synovial stem cells under arthroscopy

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Patients with suspected meniscal flap tear
2. Patients with knee pain
3. 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
4. Other

Exclusion Criteria

1. Patients with poor knee alignment
2. Patients who underwent meniscus surgery or platelet rich plasma therapy
3. Patients with or history of knee ligament injury
4. Diabetic patients with poor glycemic control
5. 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
6. Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
7. Other
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FUJIFILM Toyama Chemical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical corporation keimeikai Juko Osu hospital

Aichi, , Japan

Site Status

Wakamatsu Hospital of the University of OccupationalOC and Environmental Health

Fukuoka, , Japan

Site Status

Mie Prefectural General Medical Center

Mie, , Japan

Site Status

Tokyo Medical and Dental University Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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FF31501JP301

Identifier Type: -

Identifier Source: org_study_id

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