Patent ID: 7354749

Claim:
A method of preparing donor biological material for implantation consisting essentially of: (i) incubating the donor biological material with a buffer solution at a mild alkaline pH, wherein the buffer solution comprises a proteolytic inhibitor; (ii) incubating the donor biological material with an anionic detergent at a mild alkaline pH at a concentration which is sufficient to effect decellularization but which maintains the histoarchitecture of the donor biological material, wherein said incubation is the sole incubation step with the detergent in said method of preparing the donor biological material for implantation and said anionic detergent is the sole detergent agent in the method; (iii) washing the donor biological material with a buffer solution at a mild alkaline pH, wherein the buffer solution comprises a proteolytic inhibitor; (iv) washing the donor biological material with a buffer solution at a mild alkali pH in the absence of a proteolytic inhibitor; (v) incubating the donor biological material with one or more enzymes selected from the group consisting of DNase Type I, DNase Type II, and/or RNase; and optionally (vi) placing the donor biological material in a cryoprotectant medium.