Treatment of vocal cords with autologous dermal fibroblast formulation
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Assignees
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Publication Number
US-10881695-B2
Publication Date
2021-01-05
Expiration Date
Abstract
An autologous cell therapy product composed of fibroblasts grown for each individual to be treated for vocal cord scarring. 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 cryovials containing cryopreserved autologous fibroblasts or precursors thereof, at a concentration of between 1.0×107 cells/mL and 2.7×107 cells/mL, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing.
Core Innovation
The invention provides an autologous fibroblast product stored in a cryovial for the treatment of vocal cord scarring. Autologous human fibroblast cells, or precursors thereof, are obtained from buccal mucosa of a human and are processed into a cryopreserved cell product with a specified concentration and an explicit viability threshold after freezing and thawing.
The autologous fibroblast product is cryopreserved in cryopreservation medium and stored in drug substance/drug product cryovials. The disclosed cell product is formulated for later use and is characterized by maintaining at least 85% human fibroblast cell viability after freezing and thawing. The cryovial contains a defined volume and cell concentration range, and includes cryopreservation medium for the autologous fibroblast product.
The disclosed therapy is administered by injection into the vocal fold lamina propria, described as the subepithelial compartment. The rationale links lamina propria ECM restoration to improved mucosal pliability, and the therapy is evaluated for outcomes including mucosal wave grade and patient-reported measures. Phase I clinical outcomes in five patients are reported, with safety observations and efficacy signals through 12 months.
Claims Coverage
The independent claims cover cryovials containing an autologous fibroblast product for treating vocal cord scarring, with three independent claim sets differing primarily in the specified cell concentration range and the composition of the cryopreservation medium. Each independent claim requires a viability threshold of at least 85% after freezing and thawing, and specifies that the fibroblast cells, or precursors, are obtained from buccal mucosa of a human.
Autologous fibroblast product in a cryovial for vocal cord scarring
A cryovial containing an autologous fibroblast product comprising from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, obtained from buccal mucosa of a human, at a concentration of between 1.0×10^7 cells/mL and 2.7×10^7 cells/mL, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing; and a cryopreservation medium, wherein the autologous fibroblast product is for treatment of vocal cord scarring.
Autologous fibroblast product in a cryovial with specified concentration range
A cryovial containing an autologous fibroblast product comprising from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, obtained from buccal mucosa of a human at a concentration of between 3.0×10^7 cells/mL and 4.0×10^7 cells/mL, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing; and a cryopreservation medium, wherein the autologous fibroblast product is for treatment of vocal cord scarring.
Autologous fibroblast product with defined cryopreservation medium consisting of Iscove’s Modified Dulbecco’s Medium and 7.5% dimethylsulfoxide
A cryovial containing an autologous fibroblast product comprising from about one mL to six mL of autologous human fibroblast cells, or precursors thereof, obtained from buccal mucosa of a human at a concentration of between 1.0×10^7 cells/mL and 2.7×10^7 cells/mL, wherein at least 85% of the human fibroblast cells are viable after freezing and thawing; and a cryopreservation medium that consists of Iscove's Modified Dulbecco's Medium, and 7.5% dimethylsulfoxide, wherein the cryovial is frozen, wherein the autologous fibroblast product is for treatment of vocal cord scarring.
Across the independent claims, the coverage centers on a cryovial containing an autologous fibroblast product obtained from buccal mucosa, with a specified cell volume and concentration range, and with at least 85% viability after freezing and thawing. The independent claim sets further distinguish the claimed product concentration range and, for one independent claim, specify the cryopreservation medium composition as Iscove’s Modified Dulbecco’s Medium together with 7.5% dimethylsulfoxide, for treating vocal cord scarring.
Stated Advantages
Provides safety observations in a Phase I clinical trial with temporary otalgia as a primary safety finding.
Shows efficacy signals with sustained improvement in mucosal wave grade through 12 months.
Documented Applications
Treatment of vocal cord scarring (vocal fold scarring/augmentation) by injection into the vocal fold lamina propria using an autologous fibroblast product stored in a cryovial.
Phase I clinical evaluation in five patients, reporting mucosal wave grade improvement through 12 months and patient-reported outcome measures including Voice Handicap Index (VHI) and Visual Analog Scale (VAS).
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