Estimating the Safety of Using Recombinant Analogues of Spidroins as Biodegradable Scaffolds for Regenerative Medicine

The aim of the investigation was to study toxic properties (chronic toxicity, local irritant and sensitizing effects) of medical products Hydrogel RS and Microgel RS, intended for use in regenerative medicine as implants for replacing defects of soft and bone tissues, treatment of deep burns and for in vitro cell culturing when testing medications.

Materials and Methods. The work was carried out on outbred Wistar rats, Chinchilla rabbits, guinea pigs. There was investigated chronic toxicity, local irritant and sensitizing effects of medical products Hydrogel RS and Microgel RS (GosNIIGenetika, Russia) based on recombinant spidroin (with cutaneous and intramuscular routes of administration). While investigating chronic toxicity, there were recorded integral, hematological, biochemical indices. Local irritation was studied by pathomorphological examination of the areas of medical product introduction. Sensitization was studied using maximization method and closed epicutaneous applications.

Results. Medical products Hydrogel RS and Microgel RS were found to be relatively safe when used during 90 days, they have no irritant effect when introduced epicutaneously and intramuscularly, no sensitizing properties and can be recommended for clinical testing.

Conclusion. Medical products Hydrogel RS and Microgel RS can be recommended for clinical testing as implants for replacing defects of soft and bone tissues, treatment of deep burns and for in vitro cell culturing in testing medicines.

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