Efficacy and Safety of FF-31501 in Meniscus Tear Patients
Study Details
Study Description
Brief 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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm
|
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
|
Outcome Measures
Primary Outcome Measures
- Lysholm score [Screening up to 52 weeks]
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.
Secondary Outcome Measures
- Arthroscopic assessment of the meniscus [Meniscus repair up to 52 weeks]
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.
- Knee injury and osteoarthritis outcome score (KOOS) [Screening up to the Day before injection,4,12,24 and 52 weeks]
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.
- Numerical Rating Scale (NRS) [Screening up to the Day before injection,4,12,24 and 52 weeks]
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'.
- Kellgren Lawrence [Screening up to 24 and 52 weeks]
The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with suspected meniscal flap tear
-
Patients with knee pain
-
Patients with one or more of the following symptoms
-
Feeling stuck in the kneeć»Instability of the knee
-
Knee range of motion impairment
-
Knee joint edema
- 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
-
Severe cardiovascular disease
-
Severe liver disease
-
Severe renal dysfunction
-
Severe anemiać»uncontrolled mental illness
-
Other diseases for which sudden change or worsening of symptoms can be expected during study participation
-
Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
-
Other
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical corporation keimeikai Juko Memorial hospital | Aichi | Japan | ||
| 2 | Wakamatsu Hospital of the University of OccupationalOC and Environmental Health | Fukuoka | Japan | ||
| 3 | Mie Prefectural General Medical Center | Mie | Japan | ||
| 4 | Tokyo Medical and Dental University Hospital | Tokyo | Japan |
Sponsors and Collaborators
- FUJIFILM Toyama Chemical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FF31501JP301