Treatment of vocal cords with autologous dermal fibroblast formulation
Inventors
Assignees
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Publication Number
US-8765121-B2
Publication Date
2014-07-01
Expiration Date
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.
Core Innovation
The invention relates to a method for treatment of vocal fold scarring, presbylaryngis, and vocal cord augmentation in a human in need thereof. The method comprises injecting into the vocal cord or fold a dosage formulation containing autologous human fibroblast cells, or precursors thereof, that are reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells. The formulation is characterized by at least 98% of the cells being autologous human fibroblast cells, or precursors, and by at least 85% of the cells being viable after freezing and thawing.
The dosage formulation is described as being injected in an amount of from about 1 mL to 6 mL. The formulation includes cells at a concentration between 1.0×10^7 and 2.7×10^7 cells/mL, and the disclosed therapeutic concept is aligned with use of cryopreserved autologous fibroblasts for vocal fold application. The description further supports delivery to the vocal fold subepithelial layer, including superficial lamina propria and subepithelial placement concepts, for vocal fold scarring and augmentation.
Multi-dose administration is described with treatment doses and an inter-dose interval. Delivery is discussed as using visualization during trans-cricothyroid membrane injection with fiberoptic visualization, and the document reports observed mucosal wave grade improvement through Month 12 alongside limited adverse events such as temporary otalgia.
Claims Coverage
The disclosed claims include one independent claim that covers a method for treating vocal fold scarring, presbylaryngis, and vocal cord augmentation by injecting a defined cryopreserved autologous fibroblast-based dosage formulation into the vocal cord or fold. The independent claim is supported by dependent claims that add inventive constraints on injection volume, anatomic delivery layer, cell preparation/source, multi-dose scheduling, and delivery visualization and anesthesia.
Injecting autologous human fibroblast cells into vocal cord or fold
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 1.0×10^7 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.
Defined cell viability after freezing and thawing
Injecting into the vocal cord or fold a dosage formulation wherein at least 85% of the cells are viable after freezing and thawing.
Overall, claim coverage centers on injection of a predominantly autologous human fibroblast formulation into the vocal cord or fold, with an explicit fibroblast/keratinocyte marker reactivity requirement and an explicit viability-after-freezing-and-thawing threshold, and is refined by dependent claims specifying injection volume, subepithelial layer delivery, treatment dosing and timing, and additional delivery workflow details.
Stated Advantages
Primary efficacy improvement in mucosal wave grade sustained through Month 12.
Limited adverse events, including temporary otalgia.
Documented Applications
Treatment of vocal fold scarring, presbylaryngis, and vocal cord augmentation in a human in need thereof, supported by Phase I clinical trial results and voice outcome assessments.
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