Patent ID: 9446078
Filing Date: 2016-09-20
CPC Classification: A61K,A61L,A61P

Claim Text:
1. A composition for treating a cardiac arrhythmia, comprising: a non-immunogenic regenerative biomaterial construct comprising sterilized and decellularized ECM derived from xenogeneic small intestine submucosa (SIS) tissue, said ECM comprising a decellularization level of at least 96%, said regenerative biomaterial construct being configured to be directly delivered to damaged myocardial tissue of a subject's heart, said regenerative biomaterial construct being further configured to modulate electrical said subject's heart by inducing myofibroblast proliferation and angiogenesis of said damaged myocardial tissue and, thereby, positive remodeling of said damaged myocardial tissue, when said regenerative biomaterial construct is administered to said damaged myocardial tissue, said regenerative construct being formed in vitro by a sterilization and decellularization process comprising (i) introducing said ECM into a reactor pressure vessel, (ii) introducing sterilant comprising carbon dioxide (CO2) into said reactor pressure vessel at a first controlled pressurization rate, (iii) pressurizing said reactor pressure vessel at a pressure in the range of approximately 1000-3500 psi and at a temperature in the range of 25°-60° C., (iv) maintaining said ECM in contact with said CO2 at said vessel pressure and temperature for a minimum first processing time no less than 20 minutes said steps of introducing said CO2 into said vessel interior space and maintaining said vessel pressure and temperature being performed contemporaneously during a maximum processing time no greater than 60 minutes, and (v) depressurizing said reactor pressure vessel at a depressurizing rate in the range of 725-1450 psi/min, wherein said ECM exhibits a significantly altered collagen structure and significantly reduced glycosaminoglycan (GAG) and xenogeneic antigen content compared to a non-sterilized and non-decellularized ECM derived from xenogeneic small intestine submucosa (SIS) tissue, and wherein said ECM comprises a post-processing dry weight TGF-β content of at least 2.8 pg/mg and bFGF content of at least 19 pg/mg.