"Stem cell and regenerative medicine, cellular immunotherapy and somatic cell therapy, gene editing and gene therapy have brought revolutionary progress to human disease treatment and health promotion. In addition to increasing the investment in science and technology, these biomedical frontiers and high technologies In addition to the strategic layout, the construction of relevant regulatory science systems must also be kept up to date to ensure the new treatment methods and drug application and evaluation, and promote the orderly development of new industries in China and the formation of new formats." On March 10, members of the National Committee of the Chinese People's Political Consultative Conference, Cao Xuetao, an academician of the Chinese Academy of Engineering and president of Nankai University, called for an exclusive interview with the Science and Technology Daily reporter. In Cao Xuetao's view, the rapid development of the cell therapy industry is bound to change the global bio-pharmaceutical industry landscape, which is a major strategic opportunity for the upgrading of China's pharmaceutical industry. It is of vital importance to lay a strategic position in the global medical field in the future, to lead the development of medical science and technology, and to safeguard the health of our nationals. However, because the supervision is still in its infancy, it is relatively weak. The "dry cell chaos" not only seriously harms the people's health, but also damages the international image of biomedical research and application in China. According to reports, in the field of stem cells and related fields, China's research funding in the past five years totaled more than 1 billion yuan, and achieved a series of landmark results, but stem cell and somatic treatment conversion applications have a large bottleneck, China has not yet Cell therapy products are on the market. "Although the innovative basic research in some areas of cell therapy in China has been 'running' with developed countries, and even achieving 'leading' at individual points, regulatory and trial approval has become a bottleneck in industrial development, restricting clinical applications." Cao Xuetao said that many hospitals and enterprises in China are driven by interests, and the effectiveness of cellular immunotherapy has not been properly evaluated and verified. It is applied to clinical treatment and charges, and even more, without the permission of the state. Even without the record, the genetically modified immune cells are imported into the patient, which is contrary to the prevailing international rules. "Real clinical trials should not only charge fees, but also compensate the subjects. This kind of behavior that ignores the risk of biomedical ethics and genetic manipulation is caused by the loss of moral bottom line and weak supervision." Cao Xuetao said. The application technology and supervision in the field of cell therapy in China is not yet mature, but the marketization of cell therapy has been overheated, which makes Cao Xuetao very worried. He believes that further regulation of China's cell therapy regulatory policy is very urgent. Compared with European and American developed countries and Japan, South Korea and other neighbors, China's cell treatment policy lacks relevant top-level design, the subject of supervision is unknown, objectively caused the chaos of cell therapy in China, and at the same time, less relevant policies and regulations, for cell therapy, gene therapy research The legal and regulatory instructions and regulations involved in the process are not yet detailed. Cao Xuetao suggested that the special characteristics of cell products and genetically modified cell products should be fully considered. In accordance with international regulations, the State Food and Drug Administration as the main body of supervision, set up a specialized department or review team, equipped with professional talents, will be industrialized. Cell therapy is regulated according to drugs; for cell therapy clinical trials, a relatively stable national expert committee is set up, a special green channel is opened, priority review is conducted to review its effectiveness and safety; and cell therapy clinical trials are staged in tertiary hospitals. Or a qualified hospital to carry out and pass an ethical review, to clarify the scientific and public welfare of clinical trials, to avoid charging fees to the subjects, and to provide necessary compensation to the subjects, and to be safe and effective, depending on their industrialization The prospects are further reported and regulated in accordance with drugs. (Technology Daily)
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Member Cao Xuetao: Cellular immunotherapy and stem cell therapy need to be standardized