Regenerative Medicine Clinic in Tokyo Gets Biz Improvement Order

Tokyo, Feb. 20 (Jiji Press)–Japan’s health ministry ordered a clinic in Tokyo to improve its operations Friday over its violations of the law on safety in regenerative medicine. An on-site inspection of Ginza Phoenix Clinic found violations, including administrations of cultured cells using stem cells and dendritic cells by five doctors not listed in 10 regenerative medicine plans submitted by its director, Hisashi Nagai, to the ministry. Medical institutions face penalties for false or missing entries in mandatory regenerative medicine treatment plans. Ginza Phoenix Clinic mixed reagents and drugs, such as toxoid and picibanil, when administering cultured cells for cancer treatment and prevention. Only part of this treatment was described in plans. At least seven patients received such treatment. The clinic mixed substances that cause immune reactions such as fever, to make patients to realize the effects of cell administration, an official at Ginza Phoenix Clinic said. This is a dangerous act that could have unknown consequences for the human body, a medical worker said. The inspection also revealed that the clinic had not reported cases of patients suffering infectious diseases or possibly being left disabled, to an accreditation committee that screens the safety of regenerative medicine plans. The clinic submitted an improvement report in December after the ministry accused it of mixing an unauthorized drug called “NAD +” with stem cells and administering them to a foreign woman in her 60s without describing the treatment in a submitted plan. During a follow-up inspection on Jan. 21, the ministry found that the clinic had not implemented any improvement measures and had several violations committed since April last year. END [Copyright The Jiji Press, Ltd.]