Dosage Unit Formulations Of Autologous Dermal Fibroblasts
Dosage units consist of an autologous cell therapy product composed of fibroblasts grown for each individual to be treated. The suspension of autologous fibroblasts, grown from a biopsy of each individual's own 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, of cells at a concentration of from 1.0-2.0×10 7 cells/mL. When injected into the nasolabial fold wrinkles (creases on the sides of the nose that extend to the corners of the mouth), the autologous fibroblasts are thought to increase the synthesis of extracellular matrix components, including collagen, reducing the severity of these wrinkles. Dosage and timing of administration have been demonstrated to be critical to achieving clinically significant outcomes.
1 - 12 . (canceled)
13 . A method of producing pluripotent cells for tissue repair or regeneration comprising:
providing a dosage formulation comprising between 1.0×10 7 and 2.7×10 7 cells/mL, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof, at least 85% of which are viable, and
de-differentiating the cells.
14 . The method of claim 13 , wherein the cells are de-differentiated by cell programming.
15 . A pluripotent cell formulation prepared by the method of claim 13 .
16 . The method of claim 13 , wherein the cells are de-differentiated by cell fusion.
17 . The method of claim 13 , wherein the cells are de-differentiated by somatic cell transfer.
18 . The method of claim 13 , wherein the cells are purified by using antibodies to CD104 to eliminate keratinocyte cells.
19 . The method of claim 18 , wherein the fibroblast cells are identified by using antibodies against CD90.
20 . The method of claim 13 , wherein the pluripotent cells pass endotoxin testing for administration to a human by injection.
21 . The method of claim 13 , wherein the cells have been passaged in cell culture.
22 . The method of claim 13 , wherein the cells are rendered substantially free of immunogenic proteins present in the cell culture medium by incubating the cells for a period of time in protein free medium.
23 . The method of claim 13 , wherein the pluripotent cells further comprise a cryopreservation medium.
24 . The method of claim 23 , wherein the cryopreservation medium consists of Iscove's Modified Dulbecco's Medium (IMDM) and Profreeze™ plus 7.5% dimethyl sulfoxide (DMSO).