Terumo Corporation (Headquarters: Shibuya-ku, Tokyo, Japan. President: Yutaro Shintaku) announces that its autologous skeletal myoblast sheets were conditionally approved as a cellular or tissue-based products in Japan at a meeting held today by the organization in charge of regenerative medicinal products and biological applications within the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labour and Welfare. Terumo had filed its application for approval at an earlier date.
Autologous skeletal myoblast sheets are cultured from a patient own muscle of thigh and transplanted to patient's heart under the open chest surgery. This transplantation is expected to improve the patient's 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 patient's own body.
1. Terumo began developing cell sheets in 2007 as part of its R&D on cardiac regenerative therapy. It commenced a clinical trial at three medical institutions in Japan in 2012 and completed the study in 2014. On October 30, 2014, Terumo applied to Japan's Ministry of Health, Labour and Welfare for approval to produce and market its skeletal myoblast sheets as a regenerative medicinal therapy for treating severe heart failure caused by chronic ischemic heart disease.
2. 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.