September 18, 2015
Terumo Corporation (Headquarters: Shibuya-ku, Tokyo, Japan. President: Yutaro Shintaku) announced today that it has received conditional approval for manufacturing and selling its HeartSheet autologous skeletal myoblast sheets as a cellular or tissue-based products in Japan.
HeartSheet is cultured autologous skeletal myoblast sheets from a patient own muscle of thigh and transplanted to patients heart under the open chest surgery. This transplantation is expected to improve the patients heart condition significantly. A strong point of the therapy is the absence of any adverse reaction to the cells, since they are harvested from the patients own body.
I. 60 HeartSheet cases, showing efficacy of the product and treatment
II. Superiority compared to current existing treatment to 120 cases
III. Application for official approval within 5 years
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