April 9, 2015 Regience has regeneration started a joint research of liver Regience K.K. Regience K.K. (hereafter, Regience) has concluded a joint research agreement with Keio University regarding the research of liver regeneration. In this joint research, we are going to develop the new transplantation methods of liver tissue and the regenerative medical products for the treatment of liver cirrhosis and inborn errors of metabolism. Eiji Kobayashi, Specially appointed professor of Department of Organ Fabrication, Keio University School of Medicine and the world’s expert on translational research of transplantation/regenerative medicine, is researching for applying the fabrication of human organ in clinical setting. Swine is getting more acceptable choice for experimental animal in preclinical research, especially in the field of regenerative medicine because of its biological and anatomical similarity to human. Additionally, it is easily accessed by many researchers because it has been miniaturized in late years. In this joint research, we are going to fabricate human liver tissue/organ in swine and examine whether the tissue/organ is capable of transplantation to human. Cirrhosis is a disease with which 400 to 500 thousand of people are estimated to be affected nationwide and one of the major factors that can damage the nation’s health, but there is no effective treatment for this disease. It also can lead to liver cancer or liver failure as it further progresses. Inborn errors of metabolism is congenital genetic diseases of metabolism. The majority are due to defects of single gene that codes for enzyme. Liver is often compared to a chemical factory, because liver has many metabolic pathways. Therefore, many metabolic disorders caused by reduced function of the liver. Radical treatment of these disease is liver transplantation only. However, the donor of liver transplantation is short chronically. Furthermore, newborn infants can not receive immediately the liver transplantation after the diagnosis of inborn errors of metabolism from the standpoint of safety of perioperative care. Some of them with serious metabolic disorder that could not undergo liver transplantation will develop hepatic encephalopathy. 1 Regience is going to develop the implantable liver tissue. In newborn infants with inborn errors of metabolism, they can prevent hepatic encephalopathy with the use of liver tissue and receive appropriate treatment immediately after the diagnosis of metabolic disorder. The final goal of this project is fabrication of implantable human liver organ in swine for the resolution of donor shortage (Fig.1). Dr. Kobayashi, the representative of this joint research, comments as below; “Basic research of regenerative medicine in Japan has been leading the world. As well as a researcher, a company and social support are essential to make use of this science for the treatment. Across the border with academic clique and country, I want to let this project succeed for a patient.” Masanori Murayama, CEO of Regience, comments as below; “I think that the integration degree of regenerative medicine build up in the following order, cell unit, cell sheet, spheroid, and organ. In pharmacological and toxicological test, I think that it becomes essential to use the medium-sized animals such as a pig and a monkey. Because the extrapolation to human is difficult in the small-sized animals such as a mouse and a rat. Fabrication of implantable organ is a dream for human beings. This goal is far, but I am very glad to take the first step. Dr. Kobayashi is leading expert in this field and is pioneer of regenerative medicine using pig which is mainly used as medium-sized experimental animal. I am looking forward to pursuing the goal with him.” <Company profile of Regience> ▪ CEO, Representative Director: Masanori Murayama ▪ Address: Toranomon bldg. 3F, 1-1-12 Toranomon, Minato-Ku, Tokyo 105-0001 ▪ Capital fund: 705 million yen ▪ Business activities: Research & development and manufacturing/distribution of regenerative medical products Should you have any questions, please contact the following: Ms. Yukiko Takashima Public Relations, General Affairs, Regience K.K. Phone: +81-3-3431-3515 2 Fig.1 The use of swine as the liver fabrication platform 3
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