The Science Behind ViVita
The extracellular matrix (ECM) of tissues and organs is foundational to ensure the body functions optimally. The ability to harness animal-derived ECM that avoids immune rejection in human patients while retaining mechanical integrity and important bioactive is key to producing readily available tissue and organ replacement products.
The novel, patented SPEAR Platform overcomes shortcomings of the decellularization paradigm by employing protein chemistry principles of stepwise, differential solubilization to achieve antigen elimination in generation of acellular xenogeneic ECM scaffolds. Given the importance of residual antigen content on recipient in vivo graft-specific immune response, residual antigen content of BARE patches is quantified by assessment of residual known (e.g., major histocompatibility complex (MHC), α-gal) and unidentified (i.e., hydrophilic and lipophilic minor histocompatibility) antigenic components. SPEAR Platform eliminates unprecedented levels of antigens from a wide range of animal-derived tissues (e.g., pericardium, artery, vein, whole heart), eliminating up to 97% of all detectable antigens from such biomaterials.
Consequently, SPEAR Platform achieves the primary success criteria for ECM scaffold production: generating unfixed, acellular BARE patches which avoid destructive in vivo recipient graft-specific adaptive immune responses.
ECM scaffolds that avoid destructive recipient graft-specific immune responses then have potential to undergo constructive pro-regenerative in vivo recipient cellular repopulation and resultant matrix remodeling. Our group and others have demonstrated that preservation of native ECM structure-function relationships (e.g., collagen macromolecular structure) is critical to foster such constructive pro-regenerative responses. Traditional decellularization approaches disrupt native ECM composition, structure, and/or function. Such in vitro disruption in ECM structure-function properties has been shown to stimulate in vivo pro-inflammatory, pro-fibrotic, innate immune foreign body responses. Critically, SPEAR Platform preserves native ECM structure- function properties in BARE patches, thereby promoting recipient innate immune self-recognition and pro-regenerative in vivo responses. Consequently, unlike previously reported decellularization approaches, SPEAR Platform results in immunologically-acceptable, pro-regenerative xenogeneic extracellular matrix scaffolds which are recognized as "self" by the recipient and incorporated into their own body.
The novel, patented SPEAR Platform overcomes shortcomings of the decellularization paradigm by employing protein chemistry principles of stepwise, differential solubilization to achieve antigen elimination in generation of acellular xenogeneic ECM scaffolds. Given the importance of residual antigen content on recipient in vivo graft-specific immune response, residual antigen content of BARE patches is quantified by assessment of residual known (e.g., major histocompatibility complex (MHC), α-gal) and unidentified (i.e., hydrophilic and lipophilic minor histocompatibility) antigenic components. SPEAR Platform eliminates unprecedented levels of antigens from a wide range of animal-derived tissues (e.g., pericardium, artery, vein, whole heart), eliminating up to 97% of all detectable antigens from such biomaterials.
Consequently, SPEAR Platform achieves the primary success criteria for ECM scaffold production: generating unfixed, acellular BARE patches which avoid destructive in vivo recipient graft-specific adaptive immune responses.
ECM scaffolds that avoid destructive recipient graft-specific immune responses then have potential to undergo constructive pro-regenerative in vivo recipient cellular repopulation and resultant matrix remodeling. Our group and others have demonstrated that preservation of native ECM structure-function relationships (e.g., collagen macromolecular structure) is critical to foster such constructive pro-regenerative responses. Traditional decellularization approaches disrupt native ECM composition, structure, and/or function. Such in vitro disruption in ECM structure-function properties has been shown to stimulate in vivo pro-inflammatory, pro-fibrotic, innate immune foreign body responses. Critically, SPEAR Platform preserves native ECM structure- function properties in BARE patches, thereby promoting recipient innate immune self-recognition and pro-regenerative in vivo responses. Consequently, unlike previously reported decellularization approaches, SPEAR Platform results in immunologically-acceptable, pro-regenerative xenogeneic extracellular matrix scaffolds which are recognized as "self" by the recipient and incorporated into their own body.