Treatment of vocal cords with autologous dermal fibroblast formulation
Inventors
Assignees
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Publication Number
US-9415075-B2
Publication Date
2016-08-16
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 tunes approximately three to six weeks apart, of cells at a concentration of from 1.0-2.0×107 cells/mL.
Core Innovation
The disclosed invention relates to an autologous fibroblast cell therapy product and method for treatment and/or vocal fold augmentation. The therapy is directed to vocal fold scarring, presbylaryngis, and vocal cord augmentation in a human in need thereof, and the product comprises autologous human fibroblast cells or fibroblast precursors formulated for injection into the vocal cord or fold.
A dosage formulation is prepared using autologous human fibroblast cells obtained from a patient biopsy, including buccal mucosa biopsy and also discussing a post-auricular skin biopsy for fibroblasts. The fibroblasts are expanded under CGMP and cryopreserved, and the formulation includes at least 98% autologous human fibroblast cells or precursors and at least 85% viability after freezing and thawing.
Administration is performed by injection into the vocal fold via a trans-cricothyroid membrane technique with laryngoscopic visualization, including a fiberoptic laryngoscope. The cells are layered into the vocal fold subepithelial layer, including the lamina propria compartment and the superficial lamina propria layer for scarred vocal folds.
Claims Coverage
The partial document contains two independent claims. Both independent claims focus on injecting autologous fibroblast cell formulations into specified vocal fold tissue compartments while maintaining defined autologous cell purity and viability after freezing and thawing.
Injecting autologous fibroblast cells for vocal fold scarring, presbylaryngis, or vocal cord augmentation
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.
Injecting into the lamina propria with a defined autologous fibroblast dosage formulation
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.
Across the independent claims, the claim coverage centers on injection-based treatment of vocal fold scarring, presbylaryngis, or vocal cord augmentation using autologous human fibroblast cell or precursor formulations. The claims require defined ranges of injected cell numbers, a minimum 98% autologous fibroblast cell fraction, and at least 85% viability after freezing and thawing. The second independent claim further narrows the injection target to the lamina propria layer and a narrower dosage range.
Stated Advantages
Improvement trends in mucosal wave grade from week 8 through month 12 reported in the disclosed Phase I study.
Supportive trends in patient-reported outcomes (VHI/VAS/voice quality questionnaire) reported in the disclosed Phase I study.
Safety indication in the disclosed Phase I study, with temporary otalgia during injection as the only treatment-related adverse event.
Documented Applications
Treatment of vocal fold scarring and presbylaryngis in a human, including vocal cord augmentation and augmentation of vocal folds.
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