Patent ID: 8530149

Claim:
A method of delivering a recombinant factor VIII protein to a subject comprising implanting into or underneath the skin of said subject at least one genetically modified dermal micro-organ expressing and secreting at least a recombinant factor VIII protein, wherein said dermal micro-organ is an autologous explant of living tissue consisting essentially of a plurality of dermal components and lacking a complete epidermal layer and maintaining the micro-architecture and three-dimensional structure of the dermal tissue from which they are obtained, having dimensions selected so as to enable passive diffusion of adequate nutrients and gases to cells of said dermal micro-organ and diffusion of cellular waste out of said cells so as to minimize cellular toxicity and concomitant death due to insufficient nutrition and accumulation of waste in said dermal micro-organ, wherein at least some of said cells of said genetically modified dermal micro-organ express and secrete at least a portion of said recombinant factor VIII protein, and wherein said implanting of said at least one genetically modified dermal micro-organ delivers factor VIII to said subject.