- Pavel Igorevich, what is regenerative medicine? Many have heard about the benefits of stem cells, about promising genetic research, but not everyone knows what exactly this innovative area of ​​scientific activity can be useful to mankind ...

- Paradoxically, regenerative medicine is an ancient, even ancient phenomenon. Aristotle also wrote that the application of bone marrow to wounds and fractures in humans can accelerate their healing. Empirically, the idea that cells can be a cure is not new. Humanity has always tried to use the regenerative potential of the body. In the Middle Ages there were approaches reminiscent of modern tissue engineering. Doctors transplanted soft tissue from the shoulder to restore disfigured facial structures.

“And yet they did not know what cells are?”

- They did not know the definition of “cell”, but long before the formulation of the provisions of the cellular theory, people understood that the body is capable of recovering from injuries. However, the very discovery that organisms are composed of cells, and the cell is the smallest unit of life, was not enough. Next, it was necessary to open the stem cell, which was successful at the beginning of the 20th century by the Russian scientist Alexander Maximov. It is the basis of all regenerative processes in our body.

When we talk about regeneration, we immediately remember about newts and starfish, salamanders, we look at them with envy and ask the question: “Why do not we regenerate?” In fact, the human body regenerates very seriously and does it constantly! For example, red bone marrow weighing just one and a half kilograms produces almost six tons of blood cells. That is, we are constantly updated ...

“But still not as successful as newts and salamanders ...”

- In catastrophes, diseases and injuries, we, of course, do not regenerate this way, but throughout life we ​​produce a huge amount of cellular material, and in case of illness or injury we try to restore the structure of the tissue. This is just possible due to stem cells, which are found in almost all tissues of our body.

  • Stem cells
  • © Science Photo Library / Getty Images Plus

This kind of reserve is the stem cells that survived from the prenatal period. They allow you to maintain the structure of an organ or tissue throughout life, giving new cells in return for dead naturally. In the event of a catastrophe, this reserve is activated and tries to restore at least some amount of matter necessary for the functioning of this body.

- What is regenerative medicine in its modern form?

- Regenerative medicine includes several areas. Cell therapy - treatment using stem cells. Gene therapy, where we try to control the genes in the cells or use the genes themselves as a healing principle. Tissue engineering - the creation of artificial organs or tissues from cells. Now a direction has also arisen, which can conditionally be called regenerative pharmacology. This is a regenerative medicine without cell culture.

- It is clear that all of humanity needs all this, but the question arises about the security of new technologies ...

- Throughout the world, methods of regenerative medicine are referred to as high-risk therapy. This suggests that we still have too little time to work in this area. Let me remind you that over the centuries of development of pharmacology, many mistakes were made in the development of drugs, until the modern rules for their creation and testing were formed.

Regenerative medicine in its present form is about 25 years old, and we do not yet know everything about the long-term consequences, about what will happen to patients in another 20-30 years. Moreover, this is not pharmacology, where there is a medicine, its target and the described effects. In the case of stem cells, we pull one string and cannot confidently predict how many more strings will respond to our impact. Therefore, we must play it safe so as not to harm the patient.

- In what case are the methods of regenerative medicine used?

- Regenerative medicine is a serious intervention in the body, and it should be justified. We are talking about diseases where the patient has a very low chance of survival with other, "non-regenerative" methods of treatment. These are oncology, severe hereditary diseases, orphan diseases, in which young people and children, for example, often suffer and die.

If we are talking about an irreversibly leading to death and progressive disease, then we are ready to intervene ethically. To some extent, this is regeneration after injuries, which lead to a very difficult life for the victim. For example, with defects in the soft tissues of the face after a car accident, or, for example, in violation of the integrity of an important organ after surgery to remove the tumor.

- And what is permitted in principle and what is prohibited in regenerative medicine?

- There are limitations, and there are more of them. First, it is impossible to treat with technologies and methods that have not been tested on animals, that is, when preclinical studies have not been performed. These should be specific cellular or gene products, carefully tested and strictly standardized, like any drug.

The second - in the vast majority of countries the use of embryonic cells is not allowed, the creation of embryos for the destruction and obtaining of cellular products for the purpose of treatment is prohibited.

There is also ongoing debate about editing the genome for treatment, which is limited in most countries. Many experts known to me adhere to the position that this cannot be forbidden at all, because the technology is promising, but a temporary restriction is necessary until we deal with the consequences, risks and ethical issues.

- How is this sphere regulated?

- It is clear that scientists are developing new technologies, setting up experiments, studying the laws of cell functioning. This is a separate area of ​​fundamental science. But everything that relates to the treatment of a person and interference with his health is regulated by specialized executive bodies.

In Russia there is a federal law “On Biomedical Cellular Products” (No. 180-ФЗ), which is already two years old. With its help, everything related to cell therapy and stem cells is regulated, and according to it we can live and develop this direction.

- Tell me, are you cultivating stem cells? What else is your laboratory interested in, which projects are most significant?

- When developing drugs for cell therapy, we use adult stem cells that are secreted from adipose tissue, from the skin. Since stem cells can stimulate the growth of nerves and blood vessels, in animal experiments we have successfully developed a technology for treating nerve damage and several ways to stimulate the growth of blood vessels.

We have developed a method for the treatment of skin defects using tissue-engineering structures in the form of layers. We also in the laboratory asked ourselves why, after damage to the external and internal organs, a person develops scars and scars rather than healthy tissue, and is there any way to change this? Indeed, in bones, for example, after an injury, scars and scars do not form.

  • Thanks to gene therapy, scientists have learned to effectively treat hemophilia
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  • © Robert Michael / dpa

And women also have endometrial cells, which, like Prometheus’s liver, are able to grow again and again at the end of each monthly cycle. Now we are trying to understand what makes these cells special, why the scar does not form, how it is regulated, how to make other tissues behave in a similar way.

Now we are also starting work on the spleen. This is one of the few organs that is characterized by the phenomenon of ectopia, that is, "regrowth" outside the original place. A case has been described in the literature in which, after an abdominal injury, the spleen was not removed, and then small additional spleens that were formed from the spilled internal contents of this organ were found in the abdominal cavity. And now we are actively asking ourselves questions about how these unique regeneration mechanisms work and how to teach other organs to recover better.

- It turns out that humanity is only at the very beginning of this path? What are the prospects for stem cell treatment?

- If we talk about fundamental cell biology, then it gave a huge number of answers, revealed absolutely great secrets. But with regard to how these mechanisms are used to treat a person, we can say that we really are at the very beginning of the path.

The main idea that the stem cell does everything itself does not work. A huge number of cell preparations failed because the stem cell works well in the tissue in its place, and outside this context it loses control, program, its unique properties. The initial methodology was not chosen perfectly, and we need regenerative medicine 2.0, which we are now approaching.

That is why a promising area of ​​regenerative pharmacology has appeared, which is trying to “reach” the stem cell directly into the tissue and help it survive the damage and create new tissue instead of the dead.

- What can be cured with regenerative medicine now?

- Thanks to gene therapy, we have learned to effectively treat hemophilia. With the help of viruses, a normally working blood coagulation factor gene is delivered to the liver, and hemostasis is so normalized in patients that they no longer need lifelong injections of a protein preparation that has a very high cost.

Brilliant results were obtained in pediatric oncology - with the help of anticancer drugs, it was possible to cause long-term effective remissions in children with leukemia. There are successes in the treatment of strokes and autoimmune diseases with stem cells.

  • A cell is grown outside the body using 3D technology
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  • © Waltraud Grubitzsch / ZB

In tissue engineering, the restoration of ears, plastic of the genitals, intestines, bladder, and urinary canals is successfully carried out. For this, the polymer structure is seeded with the cells of the patient himself, sutured to the right place, and it can be used for many years.

There is progress in the treatment of impaired heart function. In Japan, cell therapy was carried out among patients who, due to heart failure, were forced to use an auxiliary device - a portable pump that helps pump blood. As a result of therapy, the contractile function of the heart increased, and the pumps became unnecessary, they were able to manage with their hearts.

- And we have a lot of elderly and even young people who have faced similar problems. How accessible is cell therapy now, and when will it be available everywhere?

- In Russia, regenerative medicine has developed over many years outside the regulatory context that exists today. Since the legal field has just formed, we do not yet have registered cellular products. This process is not fast, it may take 5-7 years more. Cellular products are very expensive all over the world, and few can afford them. The cost of treatment is paid for by insurance, is covered by charitable foundations that help patients with a specific pathology.

Nevertheless, it must be said that without the rich experience of many generations of cellular biologists, hematologists, biochemists and embryologists, which preceded formal questions, we would not have had so many effective working scientific groups. Many of them are now preparing to transfer their promising developments from experiment to preclinical studies, in order to give us new breakthrough technologies and products.

- Can you give forecasts for the near future?

- This area will definitely develop throughout the world, the need for it will be great. We went through a series of disappointments. Many expected that stem cells could cause complete brain regeneration, stop the process of myocardial death, or cause its complete recovery after a heart attack. This did not happen; the simple way did not work. The beneficial effect, of course, was, but often comparable to treatment methods without the use of cells.

Further tricks, physiologically justified interventions in the cell, have already gone. In the next five years, the industry will grow, the availability of technology will increase. In Russia, I think, preclinical studies will be completed and clinical ones will be launched. I hope that the state will find money for this, and everyone who needs our technologies and products will receive them in the right amount.

We need stability, which can be ensured by the symbiosis of science, investment and state interests. Then we can solve very serious problems, we will not lag behind Europe.

Contrary to popular belief, the West is also not going so smoothly. Products appear, then leave the race. Prospective fail, and unpromising "shoot." No one in the world knows exactly how to develop regenerative medicine, everyone is full of bumps. The main thing is that only we, and not the patients, fill these bumps.