The regulatory measures and clinical application of stem cell technology in China.

There are more than 5,300 registered stem cell clinical trials in the world, only 300 in China, less than 10 in the international research and development of more than 500 stem cell drugs, and 0 for the number of standardized stem cell conversion applications and stem cell listed products.
the Data of China Science, a reporter at the 635th Symposium of the Xiangshan Science Conference in Beijing on September 19th.
the conference on "Regenerative Repair and Personalized Treatment based on Stem Cells and Genomics", facing the gap facing the transformation of stem cell technology in China, experts suggested that the supervision of stem cell technology in China should draw on the management mode of drug research and development to promote the clinical application of stem cells and the development of related industries.
the regulatory measures of stem cell technology suggest that stem cells as "seed" cells can participate in cell substitution and tissue regeneration due to the proliferating and differentiation characteristics, which brings hope to the treatment of many difficult diseases.
However, in recent years, stem cells have often been abused in expensive beauty and clinical practices in China. The tendency of
institutions to profit-sexist is obvious, the quality of stem cell preparation has serious hidden dangers, lack of effective academic, ethical review and informed consent and other issues have attracted the attention of experts.
" a large number of clinical applications of stem cells with unknown therapeutic effects for profit-making purposes have led to 'stem cell confusion', which has had a negative impact on science and market development. Zhou Qi, executive chairman of the
" meeting and a member of the Chinese Academy of Sciences, said in the meeting report.
the supervision of the clinical application of stem cells in China has been moving forward in the rough.
May 2009, the former Ministry of Health released the First List of Third Types of Medical Technologies allowed for Clinical Application, which will include stem cell treatment as a third type of medical technology, managed separately by the Ministry of Health.
July 2012, the Ministry of Health banned stem cell therapy and clinical trials.
August 2015, the State Food and Drug Administration (CFDA) and the Commission jointly issued policies such as the Measures for the Management of Stem Cell Clinical Research (Trial) and the Guidelines for Quality Control of Stem Cell Preparations and Preclinical Research (Trial), which regulate stem cell research according to the specifications of drugs and biological products, and put forward strict restrictions on the medical institutions that conduct clinical research on stem cells, emphasizing the normative nature of the scientific research phase.
, then, into the industrialization stage, stem cell technology belongs to the "drug" or "technology"? "Stem cells should be considered a living drug.
, " Zhou Qi pointed out.
it is understood that drug management adopts the approval system, before entering clinical trials, new drugs must obtain CFDA approval of the drug clinical trial approval, one after another to carry out the first, second and third phase of trials to ensure its safety and efficacy.
and medical technology is the use of record management, focus on the after-the-fact management.
, the experts believe that only by drawing on the path of drug research and development to manage stem cells, can we avoid the "chaos" intensified, so that this technology truly benefit patients.
the clinical application of stem cell technology in China: primitive innovation is indispensable all over the world, and in the biotechnology industry, the stem cell industry appears to be vibrant.
, in the eyes of the experts at the meeting, more attention should be paid to the driving force behind the market: raw innovation.
at present, China has made great progress in the field of stem cells, the number of papers, influence factors and other major innovation indicators into the forefront of the world.
"But we should be aware that what we have achieved still lacks real leadership."
from the concept to the early theoretical basis, the core technology of innovation is mainly made by scientists in developed countries.
" Zhou Qi stressed, "to track things without hope, we want to pursue the source of innovation!" "To strengthen the leading scientific research in the field of stem cells in China, in December 2017, the Chinese Academy of Sciences launched the strategic pilot science and technology project "Organ Reconstruction and Manufacturing" on the basis of the strategic pilot project of "Stem Cell and Regenerative Medicine", and carried out scientific exploration on new technologies and theories such as in vitro, in situ and foreign regeneration.
conference, experts believe that eye disease treatment may be the most promising area of stem cell technology today.
a series of studies on the clinical problem of inappropriate implantation of artificial crystalline after cataract surgery in infants and young children, which seriously affects visual development.
researchers eventually confirmed that the regenerative potential of the lens, the discovery of the presence of crystalline stem cells, the creation of a new, designed to maximize the retention of crystalline stem cells of the internal minimally invasive surgery, has been applied to the clinic.
study was named Nature-Medicine as one of the top 8 breakthroughs in the global life sciences of 2016.
as Executive Chairman of the Conference, Liu Yizhi concluded: "The use of human-induced tissue organ repair is a new direction of regenerative medicine. The key to
success is to find adult stem cells with strong self-renewing and repairability, such as crystals, as internal causes, and to create a matching microenvironment as an external cause, both of which work together.
", also in the treatment of blinding eye disease, the Army Military Medical University First Affiliated Hospital Professor Yin Zhengqin led the team to successfully use human embryonic stem cell source of retinal epithelial cell suspension retinal subcavity transplantation, to treat wet geronic macular degeneration and juvenile macular degeneration.
at present, this work has entered the stage of clinical research, which is yet to be clinically transformed.
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