A pharmaceutical firm based in Hyogo is set to submit an application for government approval of cultured cells (stem cells) as medicine by the end of the year, the first firm in Japan to do so. This medical treatment is aimed at bone marrow transplant patients, to help reduce the side effects of the procedure.
JCR Pharmaceutical Co., a midsize company in Ashiya, Hyogo Prefecture is expected to set an example with the application to other companies and encourage them to use regenerative medicine products such as induced pluripotent stem (iPs) cells. The government is also hopeful that the use of cells for said purpose will prove to be promising under the revised Pharmaceutical Affairs Law that is set to take effect in the autumn of 2014.
This kind of treatment will involve harvesting bone marrow fluid from a healthy person and cells from the fluid will be cultured and used to treat graft versus host disease (GVHD), a common side effect of bone marrow or umbilical cord blood transplant surgeries. The cells to be used in treating GVHD are the ones most unlikely to reject the new organs in a body as protein from the cells hinder the attack of the immune cells. Countries such as Canada and New Zealand have already approved the use of these cells in GVHD Treatment.
Clinical trials by the company from 2007 have shown that symptoms of GVHD have disappeared within a period of six months with the use of such cells in 12 out of 14 patients including those with mild conditions. The final stage of the trial is expected to be completed by the end of the year. Approving medical drugs normally takes about a year for chemical substances but since cells are different, it may take longer than usual as, “to approve [the use of the cells], it is necessary to carefully examine the risk of infection and other problems,” said a government official.