Knee meniscal tear
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Extruded meniscus injury with radial, horizontal, degenerative tear etc. to which meniscal resection is generally indicated 2) Patients with clinical symptoms such as knee joint unstability, limitation in range of motion, hydrarthrosis and pain 3) Patients suitable for surgery 4) Patients to whom meniscal repair is technically possible 5) Patients older than 20 years on the acquisition date of informed consent before clinical study 6) Patients who gave a written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who didn't give a written informed consent 2) Patients with active infection 3) Patients positive for HIV (HIV-1, 2 Ag, Ab), HBV (HBs Ag), HCV (HCV Ab), or HTLV-1 (HTLV-1 Ab) 4) Patients with active malignant tumors 5) Patients sensitive to antibiotic 6) Pregnant or breast-feeding women 7) Patients with diabetes 8) Patients in bad general physical condition 9) When doctors decide as not appropriate to participate in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event data, including type, frequency, severity and duration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety of the autologous synovial mesenchymal stem cells 2) Subjective score by KOOS and NRS, Observation of knee, Knee functional evaluation by McMurry test and pivot shift test, Lysholm score 3) MRI examination 4) Knee X-ray examination | — |
Countries
Japan
Contacts
Medical Hospital of Tokyo Medical and Dental University Clinical Research Center