meniscus lesions
Conditions
Interventions
Transplantation of autologous synovial stem cells after meniscus repair
Sponsors
Medical Hospital of Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who participated in clinical trial of autologous synovial stem cell transplantation after meniscus repair 2) Patients who were eligible for both shipping inspection and confirmation inspection below - Sterility test - Mycoplasma negative test - Endotoxin test - Packaging/Display 3) Patients for whom transplantation of autologous synovial stem cell products could not be carried out due to nonconformity for following inspections - CFU evaluation - Cell number, viable cell ratio - Cell purity evaluation
Exclusion criteria
Exclusion criteria: 1) Patients with active infection 2) Patient with poor controlled diabetes 3) Patients with complications as shown below and poor general condition. - Severe cardiovascular disease - Severe liver disease - Severe renal dysfunction - Poor mental illness with poor control 4) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 5) Patient for whom doctors decide as not appropriate to participate in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event including type, frequency, severity and duration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety Device-related adverse event data,including type, frequency,severity and duration 2) Efficacy Lysholm score,Knee Injury and Osteoarthritis Outcome Score (KOOS),Numerical Rating Scale (NRS) | — |
Countries
Japan
Contacts
Public ContactOffice administrator
Medical Hospital of Tokyo Medical and Dental University Clinical Research Center
Outcome results
None listed