It is estimated that the market size of the domestic stem cell industry will reach 100 billion yuan by 2016.
Release time：2015-08-26
Author：
Medical Network, August 26-the State Health and Family Planning Commission and the State Food and Drug Administration recently jointly issued China's first "measures for the Administration of Stem Cell Clinical Research", which standardizes the institutional qualifications and conditions of stem cell clinical research. and explicitly prohibit the publication of stem cell clinical research advertisements, limit a number of measures to protect the rights and interests of 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.
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