Efficacy and Safety of FF-31501 in Meniscus Tear Patients
NCT ID: NCT05777967
Last Updated: 2024-02-02
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE3
18 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
human autologous synovial stem cells
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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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FUJIFILM Toyama Chemical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Medical corporation keimeikai Juko Osu hospital
Aichi, , Japan
Wakamatsu Hospital of the University of OccupationalOC and Environmental Health
Fukuoka, , Japan
Mie Prefectural General Medical Center
Mie, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
Countries
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Other Identifiers
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FF31501JP301
Identifier Type: -
Identifier Source: org_study_id
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