On the safety assurance of cell processing carried out in medical institutions for autologous immuno-cell therapy.

Autologous immuno-cell therapy of cancer has been mainly carried out in university hospitals as therapeutic research. Recently, private clinics specialized in the therapy are appearing in Japan. At present, cell processing necessary for the therapy is carried out not by pharmaceutical companies but by medical institutions. In this case, there is no government regulation on the safety assurance of the procedure. For the wholesome popularization of the therapy, however, it is of utmost importance to carry out cell processing under safety assurance, which could be done as self-regulation by medical institutions. A guideline for safety assurance tentatively set by Seta Clinic Group, which is a group of clinics specialized in the therapy and its usefulness in protecting patients from hazardous accidents are shown.