Treatment of vocal cords with autologous dermal fibroblast formulation
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 1.0-2.0×10 7 cells/mL.
1. 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 1.0×10 7 and 2.7×10 7 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.
2. The method of claim 1 wherein between one and two ml of the cells is injected.
3. The method of claim 1 wherein the cells are layered in the vocal fold subepithelial layer.
4. The method of claim 1 further comprising providing local anesthetic to the nasal cavity or larynx.
5. The method of claim 1 further comprising visualizing the site of injection using a fiberoptic laryngoscope connected to a video monitor.
6. The method of claim 1 further comprising obtaining fibroblast cells from the buccal mucosa of a human and culturing and purifying the cells prior to administration.
7. The method of claim 3 wherein one, two, three or four treatment doses of 1-2×10 7 cells/mL are injected into the subepithelial layer of each vocal fold.
8. The method of claim 7 wherein the doses are administered one to eight weeks apart.
9. The method of claim 1 further comprising thawing the cells from frozen prior to washing and concentration to 1-2×10 7 cells/ml.