The National Health and Family Planning Commission and the State Food and Drug Administration recently jointly issued my country's first ''Administrative Measures for Stem Cell Clinical Research'', which regulates the qualifications and conditions of stem cell clinical research institutions, and explicitly prohibits the publication of stem cell clinical research advertisements, and restricts a number of measures Protect the rights and interests of subject patients. Data show that it is estimated that by 2016, the market size of the domestic stem cell industry will reach 100 billion yuan. Some people in the industry believe that with the announcement of the management measures, the stem cell industry, especially in the field of treatment, will usher in spring.
Stem cell research has a clear tendency to pursue profits.
Stem cells are a class of pluripotent cells with the ability of self-replication, which can differentiate into a variety of functional cells under certain conditions. Because of their proliferation and differentiation properties, stem cells act as "seed" cells that can participate in cell replacement and tissue regeneration. As a key development field of medical frontier in recent years, stem cell research has shown a good development prospect, which has brought hope to the effective treatment of some difficult diseases and has received widespread attention.
The National Health and Family Planning Commission stated that my country has given key support to stem cell research in the "Twelfth Five-Year" science and technology plan, and has made gratifying progress. However, with the rapid development of stem cell research and transformation applications, some problems have also appeared, such as the obvious tendency of institutions to pursue profits and charge high fees; the inconsistent standards of stem cell preparation and serious hidden dangers in quality; and due to the lack of effective academic and ethical review And informed consent, it is difficult to protect the rights and interests of subjects. Some stem cell treatments that evade government regulation and lack data from preclinical studies have been repeatedly banned. It is imperative to formulate relevant management methods, standardize stem cell clinical research, and fully protect the rights and interests of subjects.
It is reported that in addition to the mature technology of hematopoietic stem cells to treat blood diseases, China has not approved the use of stem cells to treat any other diseases, which can only be used in clinical research. Some experts pointed out that the most significant problem in the clinical treatment of stem cells in China is "fever before maturity", which has been seriously expanded.
Hospitals are not allowed to charge patients
When interpreting the "Administrative Measures", the National Health and Family Planning Commission stated that the "Administrative Measures" are applicable to stem cell clinical research carried out in medical institutions, and are not applicable to hematopoietic stem cell transplantation with mature technical specifications, and stem cell clinical trials declared by drugs.
According to the administrative measures, medical institutions shall not directly enter the clinical application of stem cells after completing the clinical research of stem cells in accordance with the requirements of the administrative measures; if they apply for clinical trials for drug registration, the clinical research results obtained can be submitted as technical application materials and used for drug evaluation. During the clinical study, all original records of all information about stem cell providers and subjects must be accurate, clear and electronically backed up until 30 years after the end of the clinical study. Follow-up data on stem cell preparations should also be kept for at least 30 years from the date of final treatment.
The "Administrative Measures" also clarified that medical institutions shall not charge stem cell clinical research-related fees from subject patients, and shall not publish or publish stem cell clinical research advertisements in disguised form. Stem cell clinical research must follow the principles of science, standardization and openness, and must follow the principles of ethics and fully protect the rights and interests of subjects. Medical institutions engaged in stem cell clinical research must be tertiary A hospitals, have the qualifications of drug clinical trial institutions and the conditions to carry out related research, and have the ability to deal with the risks that may be encountered in stem cell research.
The "Administrative Measures" proposes that since the date of publication of the document, stem cell therapy-related technologies will no longer be managed in accordance with the third type of medical technology.
High-risk projects to buy insurance for subjects.
The "Administrative Measures" also stipulates that institutions that conduct stem cell clinical research should strengthen the protection of subjects. Stem cell clinical researchers must use popular, clear and accurate language to inform donors and subjects of the purpose, significance and content of stem cell clinical research, as well as expected benefits and potential risks, and sign informed consent on a voluntary basis. For projects with higher risks, research institutions should take effective measures to focus on supervision and provide corresponding protection for subjects by purchasing third-party insurance.
If a subject has a serious adverse event during the stem cell clinical study, such as infectious disease, permanent damage to human function or organ, life-threatening, death, or medical rescue, the researcher should immediately stop the clinical study.
The Administrative Measures stipulate that the national and provincial health and family planning administration and food and drug regulatory departments should establish stem cell clinical research expert committees and ethics expert committees according to work needs, and clarify the responsibilities and requirements of the expert committees. It is pointed out that the expert committees should provide technical support and ethical guidance for stem cell clinical research management, and conduct on-site verification and evaluation of registered medical institutions and research projects, supervise and inspect the research project management work of the academic and ethics committee of the institution, and promote the standardized development of stem cell clinical research.
Some data predict that by 2016, the market size of the domestic stem cell industry will reach 100 billion yuan, and the global stem cell industry will reach 400 billion billion US dollars by 2020. However, some people in the industry have pointed out that the "Administrative Measures" show that the clinical application of stem cells has not been liberalized, the development of stem cell research is still in its infancy, and it will take time for commercial application.
It is reported that the "Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations" have also been released. From the preparation of stem cell preparations, in vitro tests, in vivo animal tests, to clinical research and clinical treatment of human implantation, the stem cells used The preparation conducts related research and quality control in terms of cell quality, safety and biological effects.