A few days ago, Shenzhen Beike Biotechnology Co., Ltd. and Shenzhen People’s Hospital jointly applied for a stem cell clinical research base. Under my country’s new stem cell regulatory policy, stem cell clinical research in Shenzhen has once again set sail.
On August 21, 2015, the National Health and Family Planning Commission and the State Food and Drug Administration jointly issued two guidance documents: “Stem Cell Clinical Research Management Measures (Trial)” and “Stem Cell Preparation Quality Control and Preclinical Research Guiding Principles (Trial)”. This is the first time that my country has released normative documents for stem cell clinical research. Subsequently, on December 1, 2015, the National Health and Family Planning Commission and the State Food and Drug Administration issued the National Health Office Science and Education Letter [2015] No. 1071 “Notice on Carrying out the Registration of Stem Cell Clinical Research Institutions”, urging all provinces and cities across the country to organize the application for stem cell clinical research bases in accordance with the provisions of two normative documents. This move reflects the determination of the government authorities to accelerate the transformation process of stem cell clinical research in my country.
Beike Biotechnology is a leading international pioneer in the cell therapy industry. It has been committed to the construction and improvement of quality management implementation. It has successively passed the quality certification of the world’s advanced blood transfusion and cell therapy technology alliance, and established a full-process quality management system covering cell source, preparation, quality inspection, transportation, release, etc. During the “Twelfth Five-Year Plan” period, the “863” major project jointly undertaken by Beike Biotech and several hospitals – “Double-blind, randomized, controlled trial study of transcoronary injection of human umbilical cord Wharton’s mesenchymal stem cells in the treatment of acute myocardial infarction” project showed good clinical safety and effectiveness data of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction, demonstrating the practical operability and feasibility of the quality management system and international certification established by Beike Biotech in the cell therapy chain.
Dr. Hu Xiang, chairman of Beike Biotechnology, and Professor Li Furong, director of the Clinical Medicine Center of Shenzhen People’s Hospital, jointly stated that the two units will fully integrate the cell preparation quality management system and clinical resources of both parties in the context of my country’s good stem cell research regulatory policies. Successfully After applying for approval as a stem cell clinical research base, a number of clinical studies related to stem cell therapy will be carried out in succession, striving to make breakthroughs in the use of stem cells to treat chronic and difficult-to-treat diseases such as systemic lupus erythematosus, heart disease and other major diseases, and to explore new methods and means for building a strong health province and city.