Development of a biocompatible allogenic extra cellular matrix (MEC) for gradual dispensation of active substances

Abstract

AbstractPurpose: TBF aims to design an allogeneic extra cellular matrix that can be loaded with a large range of active substances: antibiotic, anti‐inflammatory or biological components and able to provide a gradual dispensation of these substances.Methods: TBF developed an amniotic membrane of umbilical cord (AM‐UC). The product is a moulded foam or fibres to be reconstituted in dry eyes or gel. The product is virally inactivated, freeze‐dried and sterilized. Products are safe and biocompatible. The testing product consists in a moulded small strip that can be inserted behind the lower eyelid. These products contain hyaluronic acid, growth factors and proteoglycans. They have been impregnated after gamma irradiation with a known quantity of gentamycin, dexamethasone or extracellular micro‐vesicles extracted from mesenchymal stem cells cultures. Impregnated products have been placed in an extraction medium, which has been removed and replaced at defined times. Actives substances have then been quantified in the different extracts according to appropriate methods. Gentamycin has been quantified according to the Method A from the Eur. Ph., dexamethasone by an ELISA detection kit then supported by HPLC‐MS/MS method (after a bioreactor study) and exosomes using an ELISA detection kit based on CD63 protein binding.Results: For gentamycin and dexamethasone, quantifications have shown that the products enable a progressive release during the first 6 h of extraction of 40%–60% of the active substance with still extraction after 24 h. Then a threshold is reached, and the release is stabilized over the remaining time of extraction until reaching 55%–70% of extraction. Exosomes are constantly released in extraction medium; all observation points are similar.Conclusions: The results obtained tend to show that the product developed can be impregnated with different type of active substances and allow a gradual dispensation. It could be used in ophthalmological pathologies in order to increase contact duration between the eye and the active substance.