21 December 2009

Artificial leather for the burned – "on the knee" and on enthusiasm

The Perm tragedy for those who survived the fire, for their relatives and for doctors who save the lives of burned people, will not end for a long time. It is extremely difficult to treat extensive burns: the larger the lesion area, the more difficult it is to close the wound. But in St. Petersburg, people were recently rescued - a girl and a boy, the area of burns on their bodies was almost 98%. Doctors were helped to save people by the developments of St. Petersburg scientists of the Institute of Cytology of the Russian Academy of Sciences. For almost 40 years, the Cell Culture Department of this research institute has been cultivating various cells, including human cells, and studying their properties. A cryobank of dermal fibroblasts has been created here – stored in an atmosphere of liquid nitrogen at a temperature of 196 degrees Celsius. The correspondent of IA REGNUM News visited the Research Institute of Cytology, met with development scientists and tried to figure out why unique technologies that allow saving people's lives are still not widely used.

More than 10 years ago, scientists were approached from the Military Medical Academy of St. Petersburg. Military doctors set the task – to grow cells that would replace the skin with extensive – 30% or more, burn lesions.

"We started moving in this direction and learned how to grow such cells and prepare cellular products with their participation (since not only the cells themselves are used for healing, but composites of cells and proteins that they synthesize), which are able to create a basis so that the patient's own skin can grow again on the affected surface, and these cellular the products are not rejected by the body. They are divided into two types. If it is easier to explain, then the first one is like a foundation – an analogue of the dermis, the dermal equivalent, in which there are fibroblasts in a collagen gel that produce proteins and create a certain structure on which the cells of the second type can already be located – keratinocytes that make up the epidermis (the upper part of the skin). Moreover, the lower layer can be a regulator that controls the division, movement and functioning of keratinocytes," explains the head of the cell biotechnology group, Candidate of Biological Sciences, leading researcher Miralda Blinova.

In the course of research, it turned out that the developments of St. Petersburg scientists help not only burn patients. But also for those who have non-healing trophic ulcers, fistulas, bedsores and any other wounds with a violation of the skin.

According to the head of the Department of Cell Cultures of the Institute of Cytology of the Russian Academy of Sciences, Doctor of Biological Sciences, Professor Georgy Pinaev, the St. Petersburg "artificial skin" by order of the Committee on New Medical Equipment of the Ministry of Health of the Russian Federation (this was before the reform of the Ministry of Health of the Russian Federation in the Ministry of Health and Social Development of the Russian Federation) successfully passed clinical trials at the Military Medical Academy, the Burdenko, Research Institute of Ambulance named after Janelidze. And before that, other mandatory tests of the product were passed – technical, as well as toxicological (at the Moscow Institute of Transplantology and Artificial Organs of the Ministry of Health of the Russian Federation). And scientists received the first document – the Committee on New Medical Equipment of the Ministry of Health, by its decision of June 20, 2002, recommended for serial production and use in medical practice, as well as for registration and entry into the register of medical devices "keratinocyte multilayer layer – an analogue of the epidermis of the skin for transplantation to burn surfaces sterile".

In 2006, another official document was received, this time from Roszdravnadzor – a registration certificate "for a medical device "Equivalent dermal". Thus, scientists have a completely legal legal basis to send materials to medical clinics. If they are needed, that is, something will happen, and the doctors will ask. It happened twice in St. Petersburg when it would not have been possible to save the lives of burned people without the developments of scientists of the Institute of Cytology. The girl Vika Frolov fell into a pit with boiling water, formed due to an accident on the heating main right on the street. In the photos for official use – not for the faint of heart, her body is depicted with the skin coming off. The boiler in the sauna exploded, in which there was a 16-year-old schoolboy Jasur Hamdamov, 98% of the damaged skin. In the photo, the boy has just been brought to the burn center. It's scary to look at it. Both Vika and Jasur survived, they grew new skin thanks to the professionalism of doctors and the developments of scientists. For Victoria, the Institute of Cytology has grown 1500 square centimeters of dermal equivalent, for Jasur – 3000 square meters.see dermal equivalent with fibroblasts and 500 – full skin equivalent. Miralda Blinova shows photos of smiling, lively young people.

The Department of Cell Cultures has also developed a special thermal container for transporting cellular products, and doctors are being trained on how to work with the material so that it takes root on the wound surface. And now, after the Perm tragedy, the Institute of Cytology from the Janelidze Research Institute, where the burned Permians lie, received requests – cells are needed. And scientists grow them. On a voluntary basis, simply because they cannot do otherwise. No one pays them for this, and the biotechnological production, which Pinaev and Blinova have been insisting on creating for several years, has not been, and is not in sight – all by themselves, in the laboratory. "But back in 2000, we submitted a report to the Main Military Medical Directorate of the Ministry of Defense of Russia, which commissioned this development. And we've been talking for 10 years. Twice we were invited to hearings in the Legislative Assembly of St. Petersburg - in 2007 and 2008. We have two letters with moral support from the governor Valentina Matvienko," says Blinova and emphasizes that in order to launch a small experimental production laboratory, it took a little more than 20 million rubles to make it according to the relevant standards, license, certify and produce cellular products according to the relevant documents and regulations. Scientists have also developed them, but this has not yet been approved anywhere. Only by creating an enterprise, it will be possible to close the technological chain – from cell biology to clinical application. Accordingly, at the same time, clinics can obtain a license from the Ministry of Health and Social Development to use these cellular products. "It turns out very stupid – you have developed, so create a production yourself or look for an investor. But we just don't have the time and energy to run around and suggest, and who will develop the next generation of cellular products?", – scientists say. The issue of allocating money to the Cell Culture Department was raised and discussed. As a result, scientists were invited to participate in an innovative project competition held by the city government. Participated, lost. The money was given to the developers of digital television. Of course, in the course of parliamentary hearings and meetings in the Legislative Assembly, as well as publications in the press, potential investors appeared. But they asked the same question: "When will we be able to make a profit?". Having learned that it was very soon, they retreated.

Now there seems to be an investor who would like to start production and understands that there will be no quick profit. "They share our ideology – not "how much money can be made on this, but how many lives can be saved, we don't want to disclose yet what kind of investors – so as not to jinx it," says Georgy Pinaev. But here a new obstacle arose – in order to organize production on the basis of the Institute of Cytology of the Russian Academy of Sciences, it is necessary to change the Charter of the Research Institute – this is required by law. Changing the charter of an academic institute is a very slow and troublesome matter. Two months have passed since a letter was sent from the administration of the Research Institute to the President of the Russian Academy of Sciences Yuri Osipov – there is no answer yet. Will the investor wait until the bureaucratic obstacles are overcome? Is unknown. And how many people will not be able to help during this time? Here, as they say, no comments.

Recall that in St. Petersburg, about 20,000 people annually receive various burns, about 2,500 of them need hospitalization, 25-30% of the total number of burned are children. In Russia as a whole, 2,400,000 people suffer from CVI – chronic venous insufficiency, which often results in trophic ulcers. 10% of these people need prompt help.

Portal "Eternal youth" http://vechnayamolodost.ru21.12.2009

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