Recently, Shenzhen Beike Biotechnology Co., Ltd. and Shenzhen People's Hospital jointly applied for a stem cell clinical research base. Under China's new stem cell regulatory policy, this marks another launch for stem cell clinical research in Shenzhen.
On August 21, 2015, the National Health and Family Planning Commission and the China Food and Drug Administration jointly issued two guidance documents, the "Administrative Measures for Stem Cell Clinical Research (Trial)" and the "Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research (Trial)" — China's first regulatory documents specifically targeting stem cell clinical research. Subsequently, on December 1, 2015, the National Health and Family Planning Commission and the China Food and Drug Administration issued document Guo Wei Ban Ke Jiao Han [2015] No. 1071, the "Notice on the Filing of Stem Cell Clinical Research Institutions," urging provinces and municipalities to organize stem cell clinical research base applications in accordance with the two regulatory documents — a move reflecting the government's determination to accelerate the clinical translation of stem cell research in China.
Beike Biotech is an internationally leading pioneer in the cell therapy industry. It has long been committed to building and improving its quality management system, having successively obtained accreditation from AABB (Advancing Transfusion and Cellular Therapies Worldwide) and established a full-process quality management system covering cell sourcing, preparation, quality testing, transportation, and release. During the 12th Five-Year Plan period, the "863" major project jointly undertaken by Beike Biotech and several hospitals — "A Double-Blind, Randomized, Controlled Trial of Intracoronary Injection of Human Umbilical Cord Wharton's Jelly Mesenchymal Stem Cells in the Treatment of Acute Myocardial Infarction" — generated good clinical safety and efficacy data for umbilical cord mesenchymal stem cell therapy in acute myocardial infarction, demonstrating the practical workability and feasibility of Beike Biotech's quality management system and international accreditation in the cell therapy chain.
Dr. Hu Xiang, Chairman of Beike Biotech, and Professor Li Furong, Director of the Clinical Medical Center at Shenzhen People's Hospital, jointly stated that, in the context of China's favorable stem cell research regulatory policy environment, the two organizations will fully integrate their cell preparation quality management systems and clinical resources. After the successful application for and approval of the stem cell clinical research base, multiple stem cell therapy clinical research projects will be launched, striving for breakthrough progress in using stem cells to treat chronic and refractory diseases such as systemic lupus erythematosus and heart disease, and exploring new approaches and means for building a strong-health province and a strong-health city.
