萬國法律事務所

Taiwan’s Ministry of Health and Welfare (“Ministry”) has for more than the past two years permitted autologous cell therapy.  In order to encourage medical institutions to conduct allogeneic cell therapy research, the Ministry intends to amend the regulations to accept applications for the implementation of allogeneic cell therapy technology.  However, applications must indicate the results of human clinical trials published by the medical institution itself, accompanied by domestic and foreign literature reports, and the technology can only be implemented after approval.  The Ministry is expected to make an announcement this month, and experts believe that many patients will benefit.
 
Under the new system, medical institutions and biotechnologists will be required to establish cell storage banks.  Liu Yue-Ping, the director of the medical affairs department, stated that in addition to ensuring the quality of cells, the cell bank can prevent another instance of chaos in connection with cord blood banking.  When cord blood stem cell therapy was being used frequently, many cord blood banks in the market appealed to the public to deposit neonatal cord blood, but subsequently, such cord blood could not be used due to poor conditions under which it was stored, which results led to many consumer disputes.  This time, the regulations will require effectiveness of the treatment and prevent the public from wasting money and tissue.
 
Lin Hsin-Long, director of the Hualien Tzu Chi Hospital, opined that opening up allogeneic cell therapy will be very helpful to healthcare providers and patients.  Patients suffering from the effects of acute stroke are treated with cord blood stem cells that are transfused into the patient’s body.  It is hoped that such transfusion treatments can be completed within nine days using allogeneic cell therapy, as currently only autologous cell therapy is permitted, which takes a much longer time.
 
Lin Hsin-Long emphasized that once allogeneic cell therapy is permitted, mesenchymal stem cells from fat, bone marrow, and skin can be used to treat stroke patients, and great numbers of patients will benefit.