According to a review by Nikkei Biotech, this number relates to doctor-initiated and company clinical trials under control of the Pharmaceutical and Medical Devices Agency. Regenerative medicine is classified into cell medicine” which administers cells in loose state, “regenerative medicine” which transplant cells in a three-dimensional structure and “gene therapy” which administers genetically modified cells and viruses into the body. Of the 38 clinical trials with regenerative medicine products, 15 are with cell medicines, 6 of them using autologous cells. Among the 8 clincial trials with regenerative medicine, 6 use autologous cells. Among the 15 trials on gene therapy, 4 are in vivo and 6 ex vivo. 5 use oncolytic viruses. Out of the 43 clinical trials, 18 are doctor-initiated clinical trials and 25 enterprise trials. Some of the company trials are from overseas companies that do not have a partner Japanese corporation.”
Nikkei Biotech news release, May 28, 2015