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 tunes 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, or vocal cord augmentation in a human in need thereof comprising injecting into the vocal cord or fold a dosage formulation comprising from 1.0×10 7 to 12.0×10 7 autologous human fibroblast cells or precursors thereof, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof, and 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 1.0×10 7 to 12.0×10 7 autologous human fibroblast cells or precursors thereof 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 injection.
7. The method of claim 1 wherein 98% or more of the cells are fibroblasts.
8. 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.
9. The method of claim 8 wherein the doses are administered one to eight weeks apart.
10. A method for the treatment of vocal fold scarring in a human in need thereof comprising injecting into the lamina propria layer of the vocal fold a dosage formulation comprising 1.2×10 7 to 2.4×10 7 cells, wherein at least 98% of the cells are autologous human fibroblast cells or precursors thereof, and at least 85% of which are viable after freezing and thawing.
11. The method of claim 10 further comprising providing local anesthetic to the larynx.
12. The method of claim 10 further comprising visualizing the site of injection using a fiberoptic laryngoscope connected to a video monitor.
13. The method of claim 10 further comprising obtaining fibroblast cells from the buccal mucosa of a human and culturing and purifying the cells prior to injection.
14. The method of claim 10 wherein the human receives a second injection from one to eight weeks after the first injection.
15. The method of claim 11 wherein the human receives a third injection from one to eight weeks after the second injection.
16. The method of claim 1 wherein three doses are administered three to six weeks apart.