Dose-escalating clinical trial design and ethical considerations
meniscus injury
The study is an open-label, dose-escalation phase I clinical trial conducted from January 2019 to December 2020 that investigated the role of human embryonic stem cells-derived mesenchymal stem cells (IMRCs) in the treatment of meniscus injury (ClinicalTrials.gov Identifier: NCT03839238). The protocol was approved by the ethics committee of the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (certificate of approval number: TJ-IRB20180901). According to the suggestion of the National Health Commission, we extended the follow-up time from 12-week to 48-week and obtained updated approval from the ethics committee (updated certificate of approval number: TJ-IRB20190911). This study was conducted according to the Declaration of Helsinki and Good Clinical Practice principles. All patients provided written informed consent.