Damage of articular cartilage of the Knee Articular cartilage damage,Articular cartilage disorder,osteoarthritis
Conditions
Interventions
The patient is put under general or lumber anesthesia. After arthroscopic observation, skin and joint capsule are incised and the lesion is exposed and debrided to create defect. The defect is filled
Sponsors
Matsuda Shuichi
Tsumaki Noriyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with knee articular cartilage damage of grade III of Cartilage Repair Society (ICRS) articular cartilage injury classification diagnosed by arthroscopy or MRI. 2) Patients with knee articular cartilage damage with the size of 1-5 cm2 in total. 3) Patients who is aged between 20 and 70 when they consent. 4) Patients who have consent in the form of document. 5) Patients whose cartilage damage can be assessed by MRI at the time of screening.
Exclusion criteria
Exclusion criteria: 1) Patients who has or had malignant tumorswith cancer. 2) Patients who got damage or undergo the surgery as follows less than six weeks ago. Ligament reconstruction in knee ligament (such as anterior cruciate ligament and posterior cruciate ligament) injury. Meniscal suture or partial resection for meniscal injuries. Around knee osteotomy in the lower limb alignment abnormality. 3) Patients who are scheduled for other surgeries of the lower limbs throughout this study, except prior surgery for comorbidities in this study or protocol treatment. 4) Patients who are impossible to undergo the postoperative rehabilitation due to abnormalities in the opposite lower limb 5) Patients with serious allergy to ingredients (e.g. bovine serum and/or rosuvastatin) which used for producing iPS cell-derived chondrocytes and fibrin glue in this study. 6) Patients with active infections. 7) Serious complications (e.g., heart disease, chronic respiratory disease, liver and kidney failure, uncontrolled diabetes, and hypertension) that may influence the conduct and evaluation of this study. 8) Patients who are pregnant, possibly pregnant, breast-feeding or wiling to be pregnant. 9) Patients with psychiatric disorders that may influence the conduct and evaluation of this study. 10) Patients whom the doctors considered inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1) Frequency and rate of adverse event 2) Presence or absence of tumorigenicity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Local CT at two weeks after surgery to assess the status of subchondral bone and trabecular bone 2) Whole body CT at 12 months after surgery to assess the probability of metastasis when transplanted cartilage get malignancy 3) MRI at baseline, 2 weeks, 3 months, 6 months and 12 months after surgery to assess the size, repair rate and homogeneity of the repair tissue 4) Local X-ray at baseline, 2 weeks, 3 months, 6 months and 12 months after surgery to assess the osteoarthritic change of the knee joint by using KL (Kellgren-Lawrence) grade 5) Arthroscopy at 12 months after surgery to evaluate the quality of repair tissue by using ICRS grades 6) Biopsy at 12 months after surgery to evaluate the regeneration of articular cartilage 7) Improvement of Knee injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Score at 1 year postoperatively | — |
Countries
Japan
Contacts
Public ContactShinichi Kuriyama
Kyoto University Hospital
Outcome results
None listed