Xinhua News Agency, Beijing, March 22, title: 6 more standards in the field of stem cells to further ensure biosafety and ethical standards
Xinhua News Agency reporter Dong Ruifeng
Recently, the Chinese standard cell biology will work committee will be published six groups standard dry cell field, China Kexue Yuan Institute of Zoology, National Stem Cell Repository was awarded China's first biobank accreditation certificate.
Commissioner Academy of Sciences Why develop a stem cell standard system? How to better ensure biosafety and ethical standards, while accelerating clinical application? Industry experts accepted interviews with reporters to explain this.
The treatment prospect is broad and the shortage of standards has become a "bottleneck"
The treatment prospect is broad and the shortage of standards has become a "bottleneck" Stem cells are a type of self-replicating "seed" cells that can differentiate into a variety of functional cells and participate in cell replacement and tissue regeneration.
However, due to the lack of relevant standards, there have been some confusions in this field.
"Developing standards, allowing stem cell research and application of some reference.
Dean of the Academy of Sciences As a clinician, Sun Yingpu, the chief physician of the Reproductive Center of the First Affiliated Hospital of Zhengzhou University, is most concerned about whether new technologies and new products in the field of stem cells are safe, effective and follow relevant policies and standards when used on patients.
It is difficult to continuously fill in the gaps in ethics and compliance
It is difficult to continuously fill in the gaps in ethics and compliance The 6 stem cell group standards released this time, including "Human Mesenchymal Stem Cells", "Human Retinal Pigment Epithelial Cells", "Human Induced Pluripotent Stem Cells", "Human Cardiomyocytes", "Artificial Blood Stem/Progenitor Cells", and "Primary Human Hepatocytes" 》, systematically stipulate the corresponding cell biological characteristics, key quality attributes, production technology, production process and quality control, inspection methods and rules, packaging and labeling, storage and transportation.
Wu Zhaohui, vice chairman of the China Medical Biotechnology Association, said that after the release of the series of standards, there will be a clearer basis for the filing and review of clinical studies of these six types of stem cells.
While the standard release, China National Accreditation Committee will be issued China's first Biobank with a certificate of CNAS BB0001 for the country stem cell repository.
Committee member China Ke Xueyuan stem cell regeneration research associate with the Institute of Medical Innovation Yao Peng Jin said, the development of biological sample libraries need to pay particular attention to informed consent, privacy and other ethical issues.
Academy of Sciences Group standards first promote the introduction of international standards
Group standards first promote the introduction of international standards In emerging fields such as stem cells, technological development is often "one step faster" than standard formulation.
In order to reduce regulatory gaps, my country encourages societies, associations, chambers of commerce, federations and other social organizations and industrial technology alliances with corresponding capabilities to coordinate relevant market entities to jointly formulate standards that meet the needs of the market and innovation, for the market to choose voluntarily, and increase the effective supply of standards.
Wang Zongling, secretaryof the party committee and vice president of the China National Institute of Standardization , said that the new technical standards for stem cells have reached a consensus within the academic community to meet the needs of innovation, and have important pioneering significance for future national standard formulation and promotion of the internationalization of group standards.
Party Secretary and DeanZhang Yong, a member of theInternational Organization for Standardization (ISO) , said that the current international standards for stem cells are basically still blank.
Committee member
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