Dosage unit formulations of autologous dermal fibroblasts
Inventors
Assignees
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Publication Number
US-8529883-B2
Publication Date
2013-09-10
Expiration Date
Abstract
Dosage units consist of an autologous cell therapy product composed of fibroblasts grown for each individual to be treated. The suspension of autologous fibroblasts, grown from a biopsy of each individual's own 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, of cells at a concentration of from 1.0-2.0×107 cells/mL. When injected into the nasolabial fold wrinkles (creases on the sides of the nose that extend to the corners of the mouth), the autologous fibroblasts are thought to increase the synthesis of extracellular matrix components, including collagen, reducing the severity of these wrinkles. Dosage and timing of administration have been demonstrated to be critical to achieving clinically significant outcomes.
Core Innovation
The invention provides a frozen dosage formulation for injection into humans comprising sterile diluent and between 1.0 and 2.7×10^7 cells/mL of autologous human fibroblast cells. At least 98% of the cells are autologous human fibroblast cells reactive with a cell surface marker for fibroblasts and not reactive with a cell surface marker for keratinocyte cells, and at least 85% of the cells are viable after freezing and thawing.
The invention further defines a treatment method for skin defects using injecting an effective amount of a frozen and thawed dosage formulation at the treatment site. The method injects a formulation consisting essentially of between 1.0 and 2.7×10^7 cells/mL in sterile diluent, with at least 98% fibroblast marker-reactive and keratinocyte marker-nonreactive autologous human fibroblast cells and at least 85% viable after freezing and thawing.
The invention also includes a frozen dosage formulation consisting essentially of 3.4×10^8 cells/mL sterile diluent for injection for treatment of nasolabial folds. In this formulation, at least 98% of the cells are autologous human fibroblast cells reactive with a cell surface marker for fibroblasts and not reactive with a cell surface marker for keratinocyte cells, and at least 85% are viable after freezing and thawing.
Claims Coverage
The partial content provides four independent claims. Across these claims, the inventive coverage centers on frozen-and-thawed autologous human fibroblast cell dosage formulations defined by cell concentration, fibroblast-versus-keratinocyte marker reactivity, and viability after freezing and thawing, and on treatment methods that inject the defined formulations in two or three treatments separated by four or five weeks plus or minus seven to ten days.
Frozen dosage formulation with quantified cell concentration and viability
A frozen dosage formulation for injection into humans consisting essentially of between 1.0 and 2.7×10^7 cells/mL sterile diluent for injection, wherein at least 98% of the cells are autologous human fibroblast cells reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells, and at least 85% of which are viable after freezing and thawing.
Skin defect treatment by injecting a frozen and thawed formulation in spaced repeated treatments
A method of treating skin defects comprising injecting an effective amount of a frozen and thawed dosage formulation consisting essentially of between 1.0 and 2.7×10^7 cells/mL sterile diluent for injection, wherein at least 98% of the cells are autologous human fibroblast cells reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells and at least 85% of which are viable after freezing and thawing, at the site to be treated, in two or three treatments separated by four or five weeks plus or minus seven to ten days.
Frozen dosage formulation with a specified high concentration for nasolabial folds
A frozen dosage formulation consisting essentially of 3.4×10^8 cells/mL sterile diluent for injection, wherein at least 98% of the cells are autologous human fibroblast cells reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells, and at least 85% of which are viable after freezing and thawing, for treatment of nasolabial folds.
Nasolabial folds treatment by injecting a high-concentration frozen and thawed formulation in spaced repeated treatments
A method of treating skin defects comprising injecting an effective amount of a frozen and thawed dosage formulation consisting essentially of 3.4×10^8 cells/mL sterile diluent for injection, wherein at least 98% of the cells are autologous human fibroblast cells reactive with a cell surface marker for fibroblasts and not with a cell surface marker for keratinocyte cells and at least 85% of which are viable after freezing and thawing, at the site to be treated, in two or three treatments separated by four or five weeks plus or minus seven to ten days.
Overall, the claims coverage is directed to autologous human fibroblast-based frozen and thawed injectable formulations and corresponding injection-based treatment methods, with core requirements that the formulations contain specified fibroblast cell concentrations, meet fibroblast-versus-keratinocyte marker reactivity thresholds, and maintain viability after freezing and thawing, and that treatment is delivered in two or three sessions separated by a multi-week interval.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of skin defects using injection of a frozen and thawed dosage formulation in two or three treatments separated by four or five weeks plus or minus seven to ten days.
Treatment of nasolabial folds.
Treatment of acne scars.
Treatment of restrictive burn scars.
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