Method for Decellularization of Tissue Grafts

Abstract

The subject invention pertains to materials and methods for processing tissue to produce a natural, acellular replacement tissue that is immunocompatible with a recipient. According to the subject invention, harvested tissue is subjected to wash solutions wherein only amphoteric detergent(s) are used (e.g., anionic detergents are excluded). Following extraction by amphoteric detergent(s), the tissue is washed with a buffer system to facilitate the clearance of cellular components and detergent. In one embodiment, the subject invention pertains to a replacement tissue that is a nerve graft that supports axonal regeneration, guides axons toward the distal nerve end and/or is immunologically tolerated. Preferably, the nerve graft retains essential extracellular matrix scaffolding as well as biological components that promote nerve regeneration through the nerve graft.

1 . A tissue graft comprising ruptured cells, an amphoteric detergent and no anionic detergent. 
     
     
         2 . The tissue graft, according to  claim 1 , comprising intact extracellular matrix structures. 
     
     
         3 . The tissue graft, according to  claim 1 , wherein the amphoteric detergent is selected from the group consisting of sulfobetaine-10 (SB-10), sulfobetaine-16 (SB-16), and a combination thereof. 
     
     
         4 . The tissue graft, according to  claim 1 , which is frozen. 
     
     
         5 . The tissue graft, according to  claim 1 , which is nerve tissue. 
     
     
         6 . The tissue graft, according to  claim 1 , wherein the tissue graft has neurite-promoting activity. 
     
     
         7 . The tissue graft, according to  claim 1 , which is non-immunogenic. 
     
     
         8 . A tissue graft prepared by a method comprising contacting a tissue graft with an extraction composition that comprises an amphoteric detergent at a concentration, and for a contact time, that is sufficient to rupture cells in the tissue, and wherein the method is performed in the absence of an anionic detergent.