E.S. Petrova – Junior Research Scientist, Head of the Laboratory of Experimental Physiology in IBMT, Research Center of Balneology and Rehabilitation of Federal Medical Biological Agency (Sochi, Russia) E-mail:pirogovka04@yandex.ru

V.Z. Agrba – Dr.Sc.(Med.), Head of the Laboratory of biology and immunology of cells of FSBSI «RIMP», Sochi E-mail: agrba_vz@mail.ru

G.G. Karal-Оgly – Ph.D. (Biol.), Senior Research Scientist, Laboratory of biology and immunology of cells,  Research Institute of Medical Primatology (Sochi, Russia) E-mail: karal_5@mail.ru

A.A. Lubyako – D.Sc. (Biol.), Professor, Head of IBMT Department, Research Center of Balneology 

and Rehabilitation of Federal Medical Biological Agency (Sochi, Russia) E-mail: lubyako@bk.ru

Despite the fact that the safety of BAS, the absence of side effects do not cause any doubts among researchers and is supported by a statistically long-term (more than 15-20 years) observation, the introduction of this direction in clinical practice, medical ethics and existing state standards require the determination of their biological safety in accordance with the procedure established by law and is feasible only if a detailed study of their safety at the stage of preclinical studies.

In experiments on small laboratory animals (rats, mice) and primates it is shown that the use of perfuzate containing biologically active substances (BAS), which are a set of metabolites and tissue substrates of peptide nature of xenogenic biomaterial, meets the requirements of biological safety for the parameters studied. It is shown that BAS do not have immunotoxicity, рroinflammatory cytokines are not revealed and lymphocytes fully retain functional activity. It is established that BAS do not show allergenic, teratogenic, embryotoxic, mutagenic properties, do not have cytotoxicity. It was also found that the use of BAS in a dose exceeding the clinically recommended dose in 1120 times, leads to a slowdown in the body weight gain of offspring, but causes them to increase the physical strength observed in the third generation.

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