Terumo launches HeartSheet®: a global first cellular and tissue-based product designed for the treatment of heart failure
Terumo Corporation (Headquarters: Tokyo, Japan; President and CEO: Yutaro Shintaku) announced today that in late May it commenced sales of HeartSheet - a global first cellular and tissue-based product designed for the treatment of heart failure.
HeartSheet is designed for treating severe heart failure caused by chronic ischemic heart disease. The treatment involves producing skeletal myoblast sheets by culturing skeletal myoblasts contained in muscle tissue that has been taken from the patient’s own thigh, and then transplanting the sheets onto the surface of the patient’s heart.
HeartSheet is a product comprised of two kits: Kit A for collecting the patient’s cells, and Kit B with cultured skeletal myoblasts and tools for producing sheets from cells. Kit A has already been sold to one medical institution, leading to the first case of patient cell collection covered by health insurance. Terumo estimates that the product will be used 20 to 30 cases per year for treatment.
To be a new alternative for therapies and a driver for the development of regenerative medicine
HeartSheet is expected to become a new alternative for the treatment of severe heart failure caused by chronic ischemic heart disease, for which conventional treatments, such as drug therapy and coronary artery bypass surgery,* lack efficacy.
*A surgical procedure for transplanting blood vessels from the legs or other body area to a blocked coronary artery to create an alternative path for blood to flow.
In addition, HeartSheet was the first product to be designated as a conditional approval, a system put in place for the purpose of facilitating practical applications of regenerative medicine by the Ministry of Health, Labour and Welfare of Japan. The system is attracting attention among corporations and researchers involved in cellular and tissue-based products, and the utilization of the system is expected to promote advancements in regenerative medicine going forward.
Terumo has been promoting joint research with Osaka University, where clinical research on skeletal myoblast sheets is being carried out by Professor Yoshiki Sawa as part of a project sponsored by the New Energy and Industrial Technology Development Organization (NEDO). Terumo has also participated in a research project on regenerative medicine using cell sheets. It is led by Professor Teruo Okano of Tokyo Women’s Medical University, which is part of a special consortia involved in developing advanced medical care in Japan.