Method for inactivating xenoantigens in biological tissues
AssigneeBiocompatibility Innovation S.R.L.
InventorsFilippo Naso, Alessandro Gandaglia
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Abstract
A method is for inactivating xenoantigens in biological tissues, particularly in tissues that can be used to manufacture bioprosthetic substitutes and/or in bioprosthetic substitutes that are already prepared and intended for human or veterinary clinical use. The method entails the following steps: providing a solution based on phenolic compounds, polyphenolic compounds or derivatives thereof, for the inactivation of at least part of the xenogeneic epitopes from such tissues; incubating the samples to be treated in the various solutions based on phenols/polyphenols in controlled conditions; and subjecting the treated tissues to a series of washes.
Claims7
A method for inactivating galactose-alpha 1,3-galactose (alpha-Gal) xenoantigen by binding to at least a part of a xenogeneic epitope of alpha-Gal in xenogeneic biological tissues adapted for manufacture of bioprosthetic substitutes and/or in bioprosthetic substitutes comprising said xenogeneic biological tissues that are already prepared and for implantation in humans, comprising the following steps:
- providing a solution comprising caffeic acid, for binding to at least part of the alpha-Gal xenogeneic epitope of said xenogeneic biological tissues;
- incubating the xenogeneic biological tissues adapted for manufacture of the bioprosthetic substitutes and/or in bioprosthetic substitutes in the solution comprising caffeic acid in controlled conditions, wherein the solution comprising caffeic acid inactivates the xenogeneic epitope of alpha-Gal;
- and
- subjecting the xenogeneic biological tissues to a series of washes;
- wherein the xenogeneic biological tissues are not subjected to decellularizing procedures;
- wherein after implantation of a bioprosthetic substitute comprising the treated xenogeneic biological tissue, circulating anti-alpha-Gal antibodies do not increase in response to the implantation of the treated xenogeneic biological tissue.
A method for inactivating galactose-alpha 1,3-galactose (alpha-Gal) xenoantigen by binding to at least a part of a xenogeneic epitope of alpha-Gal in xenogeneic biological tissues adapted for manufacture of bioprosthetic substitutes and/or in bioprosthetic substitutes comprising the xenogeneic biological tissues that are already prepared and for implantation in humans, comprising the following steps:
- providing a solution comprising a concentration of caffeic acid between 5 mM and 50 mM, for binding to at least part of the alpha-Gal xenogeneic epitope of said xenogeneic biological tissues;
- incubating the xenogeneic biological tissues adapted for manufacture of the bioprosthetic substitutes and/or in bioprosthetic substitutes in the solution comprising caffeic acid in controlled conditions, wherein the solution comprising caffeic acid inactivates the xenogeneic epitope of alpha-Gal;
- and
- subjecting the xenogeneic biological tissues to a series of washes, wherein the xenogeneic biological tissues are not subjected to decellularizing procedures, wherein the treated xenogeneic biological tissue comprises a percentage inactivation of the xenogeneic epitope of alpha-Gal.
Dependencies are inferred from the claim text.