traumatic chondral injury of the knee joint
Conditions
Interventions
Implantation of a scaffold-free tissue engineered construct (TEC) derived from autologus synovial mesenchymal stem cell (MSC) for cartilage repair.
Sponsors
Department of Orthopaedics, Osaka University Graduate School of Medicine
Osaka University Hospital, Medical Center for Translational Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a symptomatic (including pain, catching, locking, or joint effusion) chondral or meniscal lesion of the knee which is clinically detectable by MRI.
Exclusion criteria
Exclusion criteria: Patients with 1) Active local infection 2) Serious complications including malignancies 3) Alchol or drung abuse 4) Rheumatoid arthritis, gout, or pseudo gout 5) Abnormal alignment of lower extremity 6) Patello-femoral instability 7) Diabetes 8) Renal failure which requires dialysis 9) Infectious disease (HIV, HBV, HCV, HTLV, syphilis) 10) Pregnancy 11) the medication of corticosteroids 12) participation in other clinical trials 13)Judged inappropriate with other reason by the project investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Adverse events> presense or absence, pattern, severity, incidence and retention time of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Periodical assesement of clnical symptoms, evaluatetion by MRI, histology, activity scales (Lyshom, Tegnar), and by overall subjective assessment score (Knee Injury and Osteoarthritis Outcome Score, KOOS). Arthoscopic assessment of repaired tissue using ICRS evaluation package. | — |
Countries
Japan
Contacts
Public ContactNorimasa Nakamura
Osaka University Center for Advanced Medical Engineering and Infomatics
Outcome results
None listed