Treatment of vocal cords with autologous dermal fibroblast formulation
AssigneeFibrocell Technologies, Inc.
InventorJohn Maslowski
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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.
Claims9
A method for treatment of vocal fold scarring, presbylaryngis and vocal cord augmentation in a human in need thereof comprising injecting into the vocal cord or fold from about 1 ml to 6 ml of the formulation of a dosage formulation comprising between 1.0×107 and 2.7×107 cells/mL, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells, at least 85% of which are viable after freezing and thawing.
Dependencies are inferred from the claim text.