Regenerative therapy for articular cartilage using autologous cell sheets

Sato Masato0 sites20 target enrollmentDecember 23, 2019

Overview

No summary available.

Registry

who.int

Start Date

December 23, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Sato Masato

•Patients must meet all of the following criteria and have the ability to give informed consent:
•1\. 20 to 79 years of age at the time of giving consent (no restrictions on sex)
•2\. Patient with osteoarthritis of the knee (with indication for high tibial osteotomy)
•3\. Written consent from the patient for the participation in the clinical study
•4\. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III
•5\. Cartilage defect of 1\.0 cm^2 or above to less than 8\.4 cm^2 located at the condyle of the femur and/or the patellofemoral joint.
•\* Indication criteria for high tibial osteotomy (HTO)
•1\. Osteoarthritis of the knee on the medial side
•2\. Intact meniscus and cartilage on the lateral side
•3\. No or slight osteoarthritis of the patellofemoral joint

•Patients who meet any one of the following criteria will be excluded
•1\. Requires special ethical considerations
•2\. Has serious heart or respiratory disease
•3\. Tests positive in preoperative tests for problematic infectious disease such as HBV, HCV, HIV, HTLV\-1, syphilis
•4\. Has had surgical procedures to treat cartilage legions in the past
•5\. Women who are pregnant or lactating or are possibly pregnant
•6\. Any other condition deemed seriously problematic to the operation by the principal investigator or co\-investigators of this clinical study