Recently, Shenzhen Beike Biotechnology Co., Ltd. and Shenzhen People's Hospital jointly applied for a stem cell clinical research base — the latest milestone in Shenzhen's stem cell clinical research under China's new stem cell regulatory policy.
On August 21, 2015, the National Health and Family Planning Commission and the China Food and Drug Administration jointly released two guidance documents: the Administrative Measures for Stem Cell Clinical Research (Trial) and the Quality Control and Preclinical Research Guidelines for Stem Cell Preparations (Trial). These were the first regulatory documents China had released specifically for stem cell clinical research. The National Health and Family Planning Commission and the China Food and Drug Administration subsequently issued, on December 1, 2015, the Notice on the Filing of Stem Cell Clinical Research Institutions (Guo Wei Ban Ke Jiao Han [2015] No. 1071), urging provinces and cities across the country to organize stem cell clinical research base applications in accordance with the two regulatory documents. This reflected the determination of competent government departments to accelerate the translational process of China's stem cell clinical research.
Beike Biotech is an international leading pioneer in the cell therapy industry and has been continuously committed to the construction and refinement of its quality management system. It has obtained quality accreditation from the world-leading Association for the Advancement of Blood & Biotherapies, establishing a full-process quality management system covering cell sourcing, preparation, quality testing, transportation, and release. During the 12th Five-Year Plan period, the major 863 Program project — the "Double-Blind, Randomized, Controlled Clinical Trial of Intracoronary Injection of Human Umbilical Cord Wharton's Jelly Mesenchymal Stem Cells in the Treatment of Acute Myocardial Infarction", undertaken by Beike Biotech in partnership with multiple hospitals — produced strong clinical safety and efficacy data for umbilical cord mesenchymal stem cell therapy in acute myocardial infarction, demonstrating the practical operability 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 Medicine Center at Shenzhen People's Hospital, jointly stated that the two organizations will, against the backdrop of China's improving regulatory policies for stem cell research, fully integrate their cell preparation quality management systems and clinical resources. Following successful approval as a stem cell clinical research base, they will launch a series of stem cell therapy-related clinical studies, 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 methods and means for building a health-strong province and a health-strong city.
