China's stem cell industry is paying more and more attention to standards: the use of standardized

Experts believe that only by managing stem cells in the same way that drugs are developed can the industry avoid further "chaos" and make the technology truly beneficial to patients. The standardization of the industry and the development of standardized products is an important step for stem cell technology from basic research to clinical application.

Human embryonic stem cells (HSCS), the first product standard for embryonic stem cells in China, has attracted much attention. In addition, group standards concerning the safety, effectiveness and stability of stem cell preparations have also been issued, which provide important references for the standardized development of stem cell preparations or product research and development.

Group standards have been issued

In the past two years, the release of standards of several groups related to the stem cell industry has brought benefits to the standardized development of the industry.

The newly released group standard, human embryonic stem cells (HSCS), comprehensively considers scientific research, clinical, industrial and industrial factors, and sets requirements on the basic quality attributes of embryonic stem cells, technical guidelines for quality control, and product use and circulation.

At the end of January this year, China plastic association issued "stem cell preparation preparation and quality standard (try out)", focused on the industry standard of the stem cell preparation preparation and quality control, surrounding the samples received, sample preparations transport, samples and stem cells, and cell preparation, quality control, sample release, cell preparation storage, information management and application and back and so on each link in the specification.

At the end of 2017, the group standard "general requirements for stem cells" issued by the Chinese society of cell biology established general requirements for stem cell donor screening, tissue collection, cell isolation, culture, freezing, resusaving, transportation and testing, centering on key issues such as the safety, effectiveness and stability of stem cell preparations.

The standardized development of stem cell therapy products is favorable

More and more attention has been paid to the standardized development of stem cell therapeutic products. The release of the guiding principles for the research and evaluation of cell therapy products (trial) in 2017 promoted the development of the stem cell industry in China, and clarified the standards for the application of stem cell therapy products as medicines. Since then, a number of new stem cell drugs have been declared in China, and some of the new stem cell drug clinical trials have been approved by the national regulatory authorities.

The guidelines for the application of national key projects of "stem cell and translational research" encourage the development of stem cell products for targeted diseases in accordance with relevant regulations and requirements of the national drug administration. For example, in the 2019 guidelines for the application of the key project of "stem cell and translational research", the state supports clinical research on the use of clinically grade stem cell products for cell therapy of a major disease or injury in the nervous system, respiratory system, digestive system or skin.

Currently, the ongoing domestic stem cell clinical research projects are developing towards the direction of standardized product declaration. "Stem cells and translational research" key special project was proposed to the 2017 project - "the person of intrathecal injection of allogeneic umbilical cord mesenchymal stem cells to treat spinal cord injury clinical trials and research on mechanism of li-min rong, head of the professor has said that their ultimate goal is to form a specification of stem cell products, guide to do stem cells in the spinal cord injury and form the industrial chain, and patent protection of stem cells to treat spinal cord injury.

Conclusion

Draw lessons from international authority endorsed AABB standards such as the industry standard, the domestic industry is also gradually realized that to make cells in the treatment of more healthy and rapid development of science and technology in our country, the road of "privilege" is not desirable, and should set up industry standards, requires all enterprises within the specification and orderly competition of science and technology, to promote domestic cell technology in effective competition atmosphere really thriving.

Many people are looking forward to the legal and compliant stem cell treatment products in China as soon as possible. At present, domestic stem cells are being declared in the form of drugs in the national regulatory authorities, promoting the standardized development of stem cell treatment products in China.

This is a boon for patients, as the industry's increased focus on standards leads to more regulation, and stem cell drugs are proven in clinical trials and approved by regulators, which will ultimately make patients the real beneficiaries!