Stem cell clinical treatment "unripe first heat"

The National Health and Family Planning Commission and the State Food and Drug Administration have jointly issued China's first "Cell Cell Clinical Research Management Measures (Trial)" (hereinafter referred to as "Administrative Measures"), which regulates the institutional qualifications and conditions of stem cell clinical research, and expressly The publication of stem cell clinical research advertisements is prohibited, and a number of measures are defined to protect the rights of the patients. According to statistics, it is estimated that by 2016, the domestic market for stem cell industry will reach 100 billion yuan. Some insiders believe that with the announcement of management methods, the stem cell industry, especially the therapeutic field, will usher in spring.

Stem cell research has a clear tendency to profit

Stem cells are a kind of self-replicating pluripotent cells that can differentiate into multiple functional cells under certain conditions. Due to their proliferative and differentiation properties, stem cells can participate in cell replacement and tissue regeneration as "seed" cells. Stem cell research, as a key development field in medical frontiers in recent years, has shown good prospects for development, and has brought hope to the effective treatment of certain difficult diseases and has received extensive attention.

The National Health and Family Planning Commission said that China has given priority support to stem cell research in the “Twelfth Five-Year Plan” and has made gratifying progress. However, at the same time as the rapid development of stem cell research and transformation applications, some problems have arisen, such as the obvious tendency of institutions to profit, the high cost; the standard of stem cell preparation is not uniform, the quality has serious hidden dangers; and the lack of effective academic and ethical Review and informed consent make it difficult to protect subject rights. Some stem cell treatments that evade government regulation and lack preclinical research data have been repeatedly banned. It is imperative to formulate relevant management methods, standardize stem cell clinical research, and fully protect the rights of subjects.

It is reported that in addition to the mature hematopoietic stem cells for the treatment of blood diseases, China has not approved the use of stem cells for clinical treatment of any other diseases, and can only be used for clinical research. Some experts pointed out that the most significant problem in the clinical treatment of stem cells in China is that they are "uncooked and hot" and have been seriously expanded.

Hospitals are not allowed to charge patients

When the National Health and Family Planning Commission interpreted the Administrative Measures, it stated that the Administrative Measures apply to clinical research on stem cells in medical institutions, not to hematopoietic stem cell transplants with established technical specifications, and stem cell clinical trials declared by drugs.

The "Administrative Measures" proposes that medical institutions may not directly enter clinical applications after completing clinical research on stem cells in accordance with the "Administrative Measures"; for example, if they apply for drug registration clinical trials, they may submit the clinical research results obtained as technical application materials and use them for drug evaluation. . During the clinical study, all raw records of all data on stem cell providers and subjects must be accurate, clear, and electronically backed up to 30 years after the end of clinical study. Trace data for stem cell preparations should also be kept for at least 30 years from the date of final treatment.

The "Administrative Measures" also stipulates that medical institutions may not charge the patients for stem cell clinical research, and may not publish or disguise the publication of stem cell clinical research advertisements. Conducting stem cell clinical research must follow the principles of science, regulation, and openness, and must follow the principles of ethics and adequate protection of the rights of subjects. Medical institutions engaged in stem cell clinical research must be tertiary hospitals, have the qualifications of drug clinical trial institutions and carry out relevant research conditions, and have the ability to deal with possible risks in stem cell research.

The "Administrative Measures" propose that since the date of publication of the document, stem cell treatment related technologies are no longer managed in accordance with the third type of medical technology.

High risk projects require insurance for the subject

The Administrative Measures also stipulate that institutions conducting stem cell clinical research should strengthen subject protection. Stem cell clinical researchers must inform donors and subjects about the purpose, significance, and content of the stem cell clinical research, as well as expected benefits and potential risks, in a common, clear, and accurate language, and sign informed consent on a voluntary basis. . For projects with higher risks, research institutions should take effective measures to carry out key supervision and provide corresponding guarantees for the subjects by purchasing third-party insurance.

If a subject experiences serious adverse events during a stem cell clinical study, such as an infectious disease, permanent damage to the body's function or organs, life-threatening, death, or medical rescue, the researcher should immediately stop the clinical study. .

The "Administrative Measures" stipulates that the national and provincial health and family planning administrative and food and drug supervision departments shall establish a stem cell clinical research expert committee and an ethics expert committee according to the needs of the work, and clarify the responsibilities of the expert committee, stating that the expert committee shall provide for stem cell clinical research management. Technical support and ethical guidance, on-site verification and evaluation of medical institutions and research projects that have been filed, supervision and inspection of institutional and ethics committee research project management, and promotion of stem cell clinical research norms.

According to some data, by 2016, the domestic market for stem cell industry will reach 100 billion yuan. By 2020, the global stem cell industry will reach 400 billion US dollars. However, some people in the industry have suggested that the "Administrative Measures" show that the clinical application of the stem cell field has not been liberalized, and the development of stem cell research is still in its infancy, and it takes time to commercialize it.

It is reported that the "Guidelines for quality control of stem cell preparations and preclinical research (trial)" are also released together, from the preparation of stem cell preparations, in vitro tests, animal experiments in vivo, to the clinical research and clinical treatment of implanted human body. The stem cell preparations used are related to research and quality control in terms of cell quality, safety and biological effects.