It can extend life by 25-30 years.
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the Law on biomedical cell products (BMCP), authorizing the use of living cells for the treatment of a person, entered into force in Russia on 1 January. What new features will appear in connection with this, doctors and their patients, not does the cell of the harm to those who will them to be treated? These are the questions we asked one of the developers of the law, the Director of the Institute of biology of development. N. K. Koltsov of the RAS Andrey VASILYEV.
photo: PhotoXPress
-Andrey Valentinovich, let’s first explain to readers what is biomedical cell products?
– these are medical products, which will be live grown human cells. Cells are never transplanted into the body in its original form, they are always in some kind of solution or as part of some compositions can be plotted on a matrix dressings. A product with living cells can coexist preservatives, special media for maintaining the viability of cells or even antibiotics.
-Despite the fact that the law came only now, we long heard in commercials for cellular technology? It turns out, all previous proposals were illegal?
- the New law formed a system, a regulatory framework for all stages of the development, production and application of cellular products. Previously, this framework was not, was not the registration procedure, examination system, rules for the conduct of preclinical and clinical trials. But the cells really have been used either in medical technologies or as part of medical devices. But not more than 10 organizations have registered their innovation efforts, while at least hundreds of used cell technologies for its own purposes without any check and control. Basically, living cells were used in areas where you can immediately receive payment from the patient, for example, in cosmetology.
- Positive results were?
-it is Very difficult to evaluate. Have formed the practice of evaluation of efficacy of drugs and medical devices based on clinical trials that involve hundreds or even thousands of patients, analysis of positive and negative results. We have been alerted that many conferences were reported only on the positive results of impact cellular products. This can not be. Foreign experience and a lot of open sources shows that there are cases of complications. Just recently there was information about the death of 13 (!) patients in the treatment which used living cells. This is a fairly new field of medical activity, and therefore there must be a special relationship.
what is the main risk of the use of cell products?
- Risk two: this is the ability to transfer together with the cells of infectious agents, and the possibility of inducirowannoj (development) of a tumor, which can lead to an excess of rapidly dividing cells. Why in the world are using cells is regulated by separate legislative acts. Now there is one, and we have.
What diseases can be overcome by using cellular technologies?
- the Potential for their use, of course, much more than just the field of cosmetology. Worldwide cellular products are prepared to win some serious social disease. Cellular products open perspectives in the treatment of neurodegenerative diseases and stroke, in the restoration of liver functions. Cells hope a cardiologists who have been able with the help of cardiomyocytes (muscle cells of the heart) to restore the heart after heart attacks, oncologists have established the production of anti-tumor vaccines. In our country there are now 3-4 of the team who are already developing similar vaccines.
it is believed that cells can change our life as well as it once did antibiotics, increasing a person’s life by 25-30 years, when the pneumonia was no longer considered a death sentence. The introduction of new technologies will provide a breakthrough in the treatment of several incurable diseases yet.
you Can again talk about the life extension of 25-30 years?
- I Think it is, but for a broad introduction of cellular products. What distinguishes them from donating tissues and organs? That it is possible to obtain cells from the person to grow, to modify them properly and to return again in the same body. Here begins personalized medicine, we can speak about successful treatment of hereditary diseases. Today in literature already established approaches to the treatment of thus the muscular dystrophies, a number of diseases of the blood system and liver. In the next year or two the result, of course, will not, but the research is conducted, and the adoption of the law, of course, will affect their intensity.
- What products can we expect in the first place?
- World experience suggests that it may be cells used to restore cartilage, skin, cornea, urethra, bones. Products that are abroad have 5-10 years of experience.
lately, there’s news about the successful treatment of senile diseases in laboratory mice with blood transfusions of young individuals. This refers to the use of a living cell?
- Now it is very actively developed methods for the prevention of aging. Came several articles, according to which this goal can be achieved in two main ways: when special design removes aging cells, and when injected into the body young cells. In principle, these manipulations fall under the regulation of our law. But it should be understood that the methods are still under development, and from the results obtained on mice, are still very far from clinical trials on humans. This is a very long way. And the new law this way is clearly specified. He’s not reglamentary research, but once the scientist wants to apply the method of cell therapy in the clinic, he will have to undergo a certain procedure. The patient this will give you the product with guaranteed quality. Cell therapy can be paid by the state as paid organ transplantation and many other kinds of high-tech medical care.
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