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Information × Registration Number 0219U101937, 0119U003505 , R & D reports Title Conducting preclinical studies on the basis of an accredited laboratory of the co-executing organization. popup.stage_title Head Berehova Tetiana V., Registration Date 03-12-2019 Organization Taras Shevchenko National University of Kyiv popup.description2  Object of study: an environment conditioned with mesenchymal stem cells, which is required for the manufacture of biotechnological wound coatings. Purpose: To analyze the safety of new biotechnological wound coatings in an in vivo laboratory experiment designed to treat massive burns and other traumatic skin lesions. Research methods: pathophysiological, biochemical, hematological, histological. The report analyzed the results of an experiment to determine the maximum tolerated dose of the test environment. For this purpose, the substance was introduced to the fasting animals in the digestive tract using a special intragastric probe at doses of 5 ml / kg, 10 ml / kg, 15 ml / kg, 20 ml / kg and 25 ml / kg - the maximum volume for rats. The rats were then monitored daily for 14 days. They paid attention to the appearance of animals, their behavior, their consumption of feed and water. Observations included the registration of changes in the skin, eyes, mucous membranes, body temperature. To determine the weight and weight gain of rats, animals were weighed every 3 days. After 14 days, autopsy was performed and macroscopic examination and description of the internal organs, as well as determination of the relative mass of organs (heart, liver, kidneys, adrenal glands, prostate, ovaries, testes, pituitary, spleen, brain). All detected pathological changes were recorded and subjected to further histological examination. The complex of researches on the study of acute toxicity of the environment, conditioned by mesenchymal stem cells in rats of both sexes, allowed to establish the absence of toxic effect of the drug in the intragastric route of administration (LD50> 5000 mg / kg). According to the classification of substances by toxicity, the environment conditioned by mesenchymal stem cells belongs to the V class of toxicity of substances - practically non-toxic substances by intragastric administration. Product Description popup.authors popup.nrat_date 2020-04-02 Close