Treatment of Vocal Cords With Autologous Dermal Fibroblast Formulation

摘要

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 1.0-2.0×107 cells/mL.

主权项

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 a dosage formulation comprising between 1.0 and 2.7×107 cells/mL autologous human fibroblast cells or precursors thereof, at least 85% of which are viable.