Polydactyly-derived allogeneic chondrocyte cell-sheet transplantation with high tibial osteotomy as regenerative therapy for knee osteoarthritis.

"Competing interests Each author certifies that M.S. has been involved in the following relevant financial activities outside of this work and/or other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, this manuscript: funding from CellSeed Inc. M.S. is one of the inventors on the patents (PCT/JP2006/303759, PCT/JP2017/031136) held by the applicants Tokai University and CellSeed Inc. for the manufacturing process of chondrocyte sheets. The remaining authors declare no competing interests."

"We thank Professor Rumiko Shimazawa (Tokai University School of Medicine) and Dr. Setsuko Hashimoto (CellSeed, Inc.) for their contributions to this project. We also thank the Support Center for Medical Research and Education at Tokai University for technical support in the histological analysis. One of the authors has received funding from the following sources. This research was supported by the Research Project for Practical Applications of Regenerative Medicine (Grant numbers JP15bk0104001, JP17bk0104063, and JP20bk0104101 to M.S.) from the Japan Agency for Medical Research and Development."

"Our clinical study was designed as a single-arm, nonrandomized, uncontrolled comparative study. This study (UMIN Clinical Trials Registry, UMIN000015205, and Japan Registry of Clinical Trials, jRCTa030190242) was approved by the Institutional Review Board of the Tokai University School of Medicine and by the MHLW of Japan. Written informed consent was obtained from all participants. The CONSORT flow diagram is shown in Fig. ."