Treatment Of Vocal Cords With Autologous Dermal Fibroblast Formulation

Abstract

Dosage units consist of an autologous cell therapy product composed of fibroblasts grown for each individual to be treated for augmentation or regeneration of vocal cords. The suspension of autologous fibroblasts, grown from a biopsy of each individual's own buccal mucosa or skin using current good manufacturing practices (CGMP) and standard tissue culture procedures, is supplied in vials containing cryopreserved fibroblasts or precursors thereof, having a purity of at least 98% fibroblasts and a viability of at least 85%, for administration of from one to six mL, preferably two mL administered three times approximately three to six weeks apart, of cells at a concentration of from 1.0-2.0×107 cells/mL.

1 - 9 . (canceled) 
     
     
         10 . A cryovial containing an autologous fibroblast product comprising:
 autologous human fibroblast cells, or precursors thereof, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing; and   a cryopreservation medium, wherein the autologous fibroblast product is for treatment of vocal cord scarring, presbylaryngis, or vocal cord augmentation.   
     
     
         11 . The cryovial of  claim 10  wherein the fibroblast cells are obtained from skin of a human. 
     
     
         12 . The cryovial of  claim 10  wherein the fibroblast cells are obtained from the buccal mucosa of a human. 
     
     
         13 . The cryovial of  claim 10  wherein the cryovial comprises a volume from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, at a concentration of between 1.0×10 7  cells/mL and 2.7×10 7  cells/mL. 
     
     
         14 . The cryovial of  claim 10  wherein the cryovial comprises a volume from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, at a concentration of between 3.0×10 7  cells/mL and 4.0×10 7  cells/mL. 
     
     
         15 . The cryovial of  claim 10  wherein the cryovial comprises a volume of 1.2 mL of autologous human fibroblast cells, or precursors thereof, at a concentration of between 1.0×10′ cells/mL and 2.7×10 7  cells/mL. 
     
     
         16 . The cryovial of  claim 10  wherein the human fibroblast cells or precursors thereof are reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells. 
     
     
         17 . The cryovial of  claim 10  wherein the cryovial is free of endotoxin. 
     
     
         18 . The cryovial of  claim 10  wherein the cryopreservation medium consists of Iscove's Modified Dulbecco's Medium, and 7.5% dimethylsulfoxide. 
     
     
         19 . A cryovial containing an autologous fibroblast product comprising:
 from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof, wherein the human fibroblast cells or precursors thereof are reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing; and   a cryopreservation medium, wherein the autologous fibroblast product is for treatment of vocal cord scarring, presbylaryngis, or vocal cord augmentation.   
     
     
         20 . The cryovial of  claim 19  wherein the fibroblast cells are obtained from skin of a human. 
     
     
         21 . The cryovial of  claim 19  wherein the fibroblast cells are obtained from the buccal mucosa of a human. 
     
     
         22 . The cryovial of  claim 19  wherein the autologous human fibroblast cells, or precursors thereof, are at a concentration of between 1.0×10 7  cells/mL and 2.7×10 7  cells/mL. 
     
     
         23 . The cryovial of  claim 19  wherein the autologous human fibroblast cells, or precursors thereof, are at a concentration of between 3.0×10 7  cells/mL and 4.0×10 7  cells/mL. 
     
     
         24 . The cryovial of  claim 19  wherein the cryovial comprises a volume of 1.2 mL of autologous human fibroblast cells, or precursors thereof, at a concentration of between 1.0×10 7  cells/mL and 2.7×10 7  cells/mL. 
     
     
         25 . The cryovial of  claim 19  wherein the cryovial is free of endotoxin. 
     
     
         26 . The cryovial of  claim 19  wherein the cryopreservation medium consists of Iscove's Modified Dulbecco's Medium, and 7.5% dimethylsulfoxide. 
     
     
         27 . A cryovial containing an autologous fibroblast product comprising:
 autologous human fibroblast cells, or precursors thereof obtained from skin of a human, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing; and   a cryopreservation medium that consists of Iscove's Modified Dulbecco's Medium, and 7.5% dimethylsulfoxide, wherein the cryovial is frozen at 2-8° C., wherein the autologous fibroblast product is for treatment of vocal cord scarring, presbylaryngis, or vocal cord augmentation.   
     
     
         28 . The cryovial of  claim 27  wherein the cryovial comprises a volume from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, at a concentration of between 1.0×10 7  cells/mL and 2.7×10 7  cells/mL. 
     
     
         29 . The cryovial of  claim 27  wherein the cryovial comprises a volume of 1.2 mL of autologous human fibroblast cells, or precursors thereof, at a concentration of between 1.0×10 7  cells/mL and 2.7×10 7  cells/mL.