Knee meniscal tear
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meniscal tear such as radial tear, horizonal flap tear, complex tear and degenerative tear to which meniscal resection is generally applied 2) Patients with clinical symptoms such as knee joint unstability, limitation in range of motion, hydrathrosis and pain 3) Patients approved for treatment with 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, HIV-2), HBV, HCV, or HTLV-1 4) Patients with active malignant tumors 5) Patients with sensitivity to antibiotic 6) Pregnant or breast-feeding women 7) Patients with diabetes 8) Patients in bad general condition 9) Patients evaluated as a contraindication to the clinical study by one's doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of clinical research is evaluated on the presence, severity and frequency of adverse events caused by autologous synovial stem cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Feasibility of the quality control of cultured synovial stem cells 2) Subjective symptom (KOOS and NRS scores based on patient-oriented evaluation) and knee symptom before and after 4, 6, 12, 24 weeks of meniscal repair. 3) MRI assessment of sutured meniscus before and after 12, 24 weeks of meniscal repair 4) Width of joint space evaluated by X-ray examination before and after 12, 24 weeks of meniscal repair | — |
Countries
Japan
Contacts
Medical Hospital of Tokyo Medical and Dental University Clinical Research Center