Development of treatment of knee articular cartilage damage with iPS-cell-derived cartilage.

Not Applicable

Conditions: Damage of articular cartilage of the Knee
Articular cartilage damage,Articular cartilage disorder,osteoarthritis

Registration Number: JPRN-jRCTa050190104

Lead Sponsor: Matsuda Shuichi

Brief Summary: Allogeneic iPS cell-derived cartilage is potentially at risk for tumorigenesis, but no neoplastic growths were observed at 12 months after iPS cartilage transplantation. Therefore, the safety of iPS cell-derived cartilage transplantation in humans was confirmed. Improvements in postoperative clinical, imaging, arthroscopic, and histologic evaluation scores were also observed, suggesting that iPS cell-derived cartilage transplantation might be a useful treatment for knee articular cartilage damage.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 4

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety<br>1) Frequency and rate of adverse event<br>2) Presence or absence of tumorigenicity

Secondary Outcome Measures

Name	Time	Method
1) Local CT at two weeks after surgery to assess the status of subchondral bone and trabecular bone<br>2) Whole body CT at 12 months after surgery to assess the probability of metastasis when transplanted cartilage get malignancy<br>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<br>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<br>5) Arthroscopy at 12 months after surgery to evaluate the quality of repair tissue by using ICRS grades<br>6) Biopsy at 12 months after surgery to evaluate the regeneration of articular cartilage<br>7) Improvement of Knee injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Score at 1 year postoperatively