Updated on 29 June 2016
Tokyo: Cytori Therapeutics Inc has announced that the use of Cytori Cell Therapy was approved for clinical use on June 24th, 2016 to treat knee osteoarthritis at the Tokyo Osteoarthritis Clinic under the Japanese ‘Act on the Safety of Regenerative Medicine' that was enacted on November 25, 2014.
The press release said that Tokyo Osteoarthritis Clinic will begin to treat knee osteoarthritis patients with Cytori Cell Therapy immediately. This approval is limited to facilities under the clinic's umbrella but does not restrict the number of patients that can be treated. Such approvals are not reimbursed by the social healthcare system and patients will be responsible for the costs of treatment.
"Osteoarthritis is very common in Japan and the new legislation gives us an approved pathway to make novel regenerative therapies available to patients today," said Dr Masayuki Yamakawa, CEO of the Tokyo Osteoarthritis Clinic.
In Japan, Cytori's Celution system was granted a Class I notification originally in 2012. The recent legislation passed by the Japanese Diet originally in 2013 and later enacted and enforced, provides a mechanism allowing leading healthcare facilities in Japan to use certain regenerative medicine technologies deemed innovative and safe by the Japanese government for particular indications if approved by a certified and accredited regenerative medicine committee.
"The innovative regenerative medicine law recently approved in Japan creates expanded opportunities for therapeutic innovation for Cytori," said John Harris, Cytori's Vice President & General Manager, Cell Therapy. "This registration and those anticipated in the future should be important elements in helping us expand access for our Cytori Cell Therapy to a large population of patients in Japan suffering with osteoarthritis. For the Tokyo Osteoarthritis Clinic, this is a significant milestone and I believe they are well positioned for leadership in arthritis therapy in Japan."