In the films about superheroes, we are constantly shown characters, endowed with impressive abilities. For example, the ability in seconds to repair damaged parts of the body or reverse the aging process. It is not difficult to guess that at the heart of these fantastic phenomena lies one important principle, namely: the impact on the smallest, but the most important parts of any living organism — the cells. Agree, if the organs and tissues are sick or injured, then cells in them are more likely to have the same qualities. So, the right way to restore health is to work at the cellular level. In the most general form, this is the way to imagine the meaning of cellular medicine — a relatively new, promising, but not without question, field of science and practice.
In the beginning there was a cage.
Cellular medicine has a relatively small history — the first attempts to resort to methods of cell therapy were observed at the beginning of the last century. I must say, they were quite specific. For example, in 1912 German doctors tried to treat children with hypothyroidism by the cells of the thyroid gland, and in the 1920s French physicians tried to use abortive tissues in rejuvenating procedures. And it was caused not by scientific creativity and boldness in experiments (although without this it did not happen).
The fact is that in 1908, a Russian scientist, professor of the Military Medical Academy of St. Petersburg, AA. Maximov discovered stem cells — a special type of the main «bricks» of the body, capable of transforming into cells of those organs and tissues where a «malfunction» occurred, for example, trauma, disease or natural degradation.
The study of stem cells became a true trend in biomedicine in the second half of the 20th century, launching a new round for research in 1998, when American scientists managed to isolate human embryonic stem cells and grow them artificially. Agree, the fact that now this type of cells is most often associated with the concept of cellular medicine, is fair. However, cellular technologies actually cover a much wider range of biomaterials. When we call cellular medicine «the future of health», then we need to make a reservation. In fact, at the moment, a number of biomedical cellular technologies are already firmly established in medical practice. First of all, we are talking about the restoration of skin after burns, the treatment of damaged cartilage and bones and, of course, the active use of blood stem cells in regenerative medicine. Another moment is very important. Today, cellular development is actively being introduced into therapeutic tools for controlling diabetes, cancer, cardiovascular and neurological diseases. In other words, modern cytologists and microbiologists invent and improve drugs that are crucial for human life and health. The key point here is that all these tools and technologies are directly related to the use of biomedical cellular products (MCBs) — the cornerstone of cellular medicine. But also a stone (if not a cobblestone) stumbles too.
It is not necessary to add 1 + 1 to understand that any manipulation of cells and tissues is associated with a number of subtle nuances. Starting with questions about donors of biomaterial and ending with the temptation to use cellular technology to create a human embryo. Despite the fact that the sphere of cellular medicine is developing in giant steps (according to Scalar Market Research by 2020 this market will amount to more than $ 60 billion), the national legislation of countries leading cellular development is forced to curb it. First of all, this is reflected in the establishment of international standards for biomedical cellular products and prescribing control mechanisms for their production.
It is not surprising that the Federal Law «On Biomedical Cell Products» came into force in Russia this year. By his appearance, he aroused a lot of fears and misunderstandings on the part of researchers and manufacturers of drugs on the basis of BMSP.
The state position here is clear — the fast growing segment of biomedicine needed to be removed from the «shadow». And to stimulate the growth of technological developments in socially important areas of public health. In other words, it was necessary to create a demand for cellular products for the treatment of serious diseases, and not just for solving problems (no doubt, also important) in the field of aesthetic medicine and cosmetology.In the research community the new law caused a wave of discussions. First of all, the disputes touched upon the issues of patent rights and certification of biomedical technologies, the determination of the cost price of the BCPI and many others. Many experts in the field of cellular medicine see in this normative step the attempt of the state to monopolize and indirectly bureaucratize this area. Nevertheless, as the representatives of Roszdravnadzor and the Ministry of Health assured during the round table held within the framework of the recent conference on the BMP in the Institute of Cytology of the Russian Academy of Sciences, the new law creates conditions for safe and effective development, and also brings the cellular products to the world level.
The expediency of the emergence of a new regulator in the field of BMSP is also seen by Igor Mikhailovich Akulin, Doctor of Medical Sciences, Head of the Department of Healthcare and Medical Law Organization of St. Petersburg State University:
«This law brings into conformity what has already been applied in practice to work with cellular technologies. The very sphere of cellular biomedicine is associated with a number of well-known nuances, such as donor issues, consequences from the use of foreign biomaterials, etc. In order to regulate these aspects, to allow this area to develop further than cosmetology, to promote the emergence of new generation drugs, to certify the products properly, and to train the appropriate specialists, and this act was adopted. It is needed as a normative foundation, which in fact creates favorable conditions for promising cellular research and their further development.»
Thus, there is still a hope that the transition period to new regulatory conditions will not impede the development of stem cell research and the evolution of cellular technologies in Russia. But at the same time it will not make this process closed and «grant-oriented».