South Korean biotechnology firm Nature Cell informed that its stem cell therapy for Alzheimer’s disease has been formally approved for use at Fukuoka Trinity Clinic, one of its partner hospitals in Japan.
This is the first time for a stem cell therapy for treating Alzheimer’s to be commercialized anywhere in the world. In Japan, stem cell therapies are not considered drugs, but fall under therapeutic technology.
To begin providing stem cell therapies, a hospital must obtain the approval of a board of regenerative medicine specialists who review the drugs’ efficacy and safety, as well as patient risks and benefits. Once approval is granted, it is delivered to the Japanese Drug Ministry for recordkeeping. Then, the hospital can begin commercially offering the stem cell treatments to patients at the facility.
Stem cells – progenitor cells able to develop into various types of tissue – are viewed as key to the field of regenerative medicine, which helps the body repair itself. Stem cell therapies are engineered by extracting stem cells from the patient’s tissue, incubating the cells, then administering them intravenously to the patient.