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 mucsoa 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 bilateral vocal fold scarring in a human in need thereof comprising injecting into the vocal cord or fold from about one mL to six mL of a dosage formulation comprising between 1.0×10 7 cells/mL and 2.7×10 7 cells/mL autologous human fibroblast cells or precursors thereof, at least 85% of which are viable after freezing and thawing.
2. The method of claim 1 wherein between one mL and two mL of the dosage formulation is administered.
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 the fibroblast cells from the buccal mucosa of the human to be treated and culturing and purifying the cells prior to administration to the human.
7. The method of claim 1 wherein one, two, three or four treatment doses of 1-2×10 7 cells/mL are injected into the superficial lamina propria layer of each scarred vocal fold.
8. The method of claim 7 wherein the doses are administered one to eight weeks apart.