Proliferative Primary Human Sertoli Cell Cultures And Their Applications

Abstract

Technology for the isolation and propagation of primary human Sertoli cells from normal testes tissue, including cultures of proliferative primary human Sertoli cells for research and clinical applications, and a pharmaceutical composition for cell therapy, ex vivo gene therapy, and for the reduction of autoimmune, allograft, and xenograft immune reactions.

1 . Technology for the propagation of primary human Sertoli cells comprising:
 (a) Methodology for the isolation of proliferative human Sertoli cells from testis tissue, and   (b) Methodology for the propagation of the proliferative human Sertoli cells in vitro.   
   
   
       2 . The technology of  claim 1 , wherein the technology is utilized to produce cells under GMP conditions for clinical use. 
   
   
       3 . Cultures comprising: proliferative primary human Sertoli cells. 
   
   
       4 . The cultures of proliferative primary human Sertoli cells of  claim 3 , wherein the cultures are produced under GMP conditions. 
   
   
       5 . The cultures of  claim 3 , wherein the said primary human Sertoli cells are polarized. 
   
   
       6 . The cultures of  claim 3 , wherein the proliferative primary human Sertoli cells are transformed or genetically modified. 
   
   
       7 . The cultures of  claim 3 , wherein said cultures are used to support the growth or differentiation of other types of cells in vitro. 
   
   
       8 . The cultures of  claim 3 , wherein said cultures are used to support the growth or differentiation of germ or stem cells in vitro. 
   
   
       9 . The cultures of  claim 3 , wherein said cultures are used to support the growth of organs or organ cultures in vitro. 
   
   
       10 . The cultures of  claim 3 , wherein said human is 28 years of age or younger. 
   
   
       11 . The cultures of  claim 3 , wherein said human is 29 years of age or older. 
   
   
       12 . The cultures of  claim 3 , wherein said cultures are used for research. 
   
   
       13 . Clonal cultures that have been derived from the cultures of  claim 3  by limiting dilution selection or fluorescence-assisted cell sorting (FACS). 
   
   
       14 . The cultures of  claim 3 , wherein said cultures are provided in a pharmaceutical composition with a pharmaceutically acceptable carrier. 
   
   
       15 . The pharmaceutical composition of  claim 14 , wherein the proliferative primary human Sertoli cells are genetically modified so as to express a recombinant protein and administered to a human for ex vivo gene therapy. 
   
   
       16 . The pharmaceutical composition of  claim 14 , wherein the composition administered to a human for cell therapy. 
   
   
       17 . The pharmaceutical composition of  claim 14 , wherein the composition is administered to the testes for treatment of male infertility due to lack of supporting cells. 
   
   
       18 . The pharmaceutical composition of  claim 14 , wherein the composition is administered to a human for immunosuppressive cell therapy. 
   
   
       19 . The pharmaceutical composition of  claim 14 , wherein the composition is administered to a human as a source of neurotrophic or growth factors. 
   
   
       20 . The pharmaceutical composition of  claim 14 , wherein the composition is administered to a human to reduce the immune response to co-implanted allogeneic or xenogeneic cells or tissue. 
   
   
       21 . The pharmaceutical composition of  claim 14 , wherein the composition is administered to a human to reduce an autoimmune response to co-implanted cells or tissue. 
   
   
       22 . The pharmaceutical composition of  claim 14 , wherein the composition is administered to a human to reduce an autoimmune response to co-implanted pancreatic islets. 
   
   
       23 . The pharmaceutical composition of  claim 14 , wherein the composition is provided in a device encapsulating the cells, and wherein said device is suitable for implantation into a mammalian subject.