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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human autologous synovial stem cells | Biological | A single injection of 1.5 to 9.0 x 10^7 human autologous synovial stem cells under arthroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lysholm score | It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively. | Screening up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arthroscopic assessment of the meniscus | The structure and function of the repaired meniscus will be assessed in terms of the presence, stability, and smoothness of the meniscus by arthroscopic imaging and MRI. | Meniscus repair up to 52 weeks |
| Knee injury and osteoarthritis outcome score (KOOS) |
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Inclusion Criteria:
Patients with suspected meniscal flap tear
Patients with knee pain
Patients with one or more of the following symptoms
Other
Exclusion Criteria:
Patients with poor knee alignment
Patients who underwent meniscus surgery or platelet rich plasma therapy
Patients with or history of knee ligament injury
Diabetic patients with poor glycemic control
Patients with the following complications and poor general condition
Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
Other
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical corporation keimeikai Juko Osu hospital | Aichi | Japan | ||||
| Wakamatsu Hospital of the University of OccupationalOC and Environmental Health |
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The KOOS consists of five subscales; Pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec) and knee related quality of life (QOL). Lowest and highest scores are 0 and 100 (better), respectively. |
| Screening up to the Day before injection,4,12,24 and 52 weeks |
| Numerical Rating Scale (NRS) | NRS consists of an 11-point scale to evaluate current knee pain where no pain is indicated by '0', and the worst pain imaginable by '10'. | Screening up to the Day before injection,4,12,24 and 52 weeks |
| Kellgren Lawrence | The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades. | Screening up to 24 and 52 weeks |
| Fukuoka |
| Japan |
| Mie Prefectural General Medical Center | Mie | Japan |
| Tokyo Medical and Dental University Hospital | Tokyo | Japan |