Shunhao biological "preclinical and clinical research of endometrial regenerative cells in the treatment of premature ovarian failure" was supported by the national major new drug development project

On the morning of September 2, Gao Chang, vice president of Shunhao Cell Biotechnology (Tianjin) Co., Ltd., led the "national major science and technology project 2014" The team of "new drug creation" came to Tianjin new drug safety evaluation center to discuss with academician Liu Changxiao of National Academy of engineering, director Shen Xiuping, director of new drug safety evaluation center of Tianjin Pharmaceutical Research Institute and other experts, and reached a consensus on the follow-up work involved in the pre clinical safety evaluation of stem cell new drug project, so as to successfully obtain the clinical approval document of national "drug review center" next year , successfully applied for phase I clinical study The research was jointly carried out by Shunhao biological company, Tianjin Pharmaceutical Research Institute, Beijing Union Medical College Hospital, Tianjin Medical University General Hospital and Tianjin Central maternity hospital, with a total amount of 7.5 million Yuan approved by the state With the first batch of national funds of 3 million yuan allocated in place, relevant supporting funds will be in place in succession It is planned to complete all pre clinical studies and apply for the first phase of clinical approval by the end of 2015 Gao Chang, vice general manager of Shunhao biology, said that the team extracted endometrial regeneration cells from women's menstrual blood, which has the function of reconstruction and repair of ovarian tissue, and is expected to achieve remission and even cure of premature ovarian failure So far, some preclinical experiments have been completed, and premature ovarian failure and diabetes mellitus have been identified as indications for clinical research Gao Chang said that the team has applied for more than 20 national patents so far and obtained four national invention patents At present, more than 5000 stem cell clinical researches have been publicly registered in the world, and the research hotspot in the field of stem cell has changed from preclinical research to clinical research More than 100 projects have entered the fourth phase of clinical research, and many stem cell products have been approved by the U.S Food and drug administration, but no one has been approved in China so far Different from the backward situation of chemical drugs, the clinical research of stem cells in China is almost the same as that in developed countries.