Topical erythropoietin formulations and methods for improving wound healing with and cosmetic use of the formulations
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Publication Number
US-12427182-B2
Publication Date
2025-09-30
Expiration Date
Abstract
Topical formulations containing erythropoietin (EPO), and also preferably fibronectin (FN), especially gel formulations, are used to accelerate wound healing, e.g., from a burn, compared to the healing process without such a formulation being applied.
Core Innovation
The disclosure describes topical wound-healing formulations comprising erythropoietin and optionally fibronectin, particularly as topical gels. The compositions are proposed to treat wounds in a subject by inducing aquaporin expression, including aquaporin-3 (AQP3), and link EPO/FN treatment with increased AQP3 expression and wound-healing-associated biological changes.
The disclosure describes a diabetic wound-healing context in which EPO, with fibronectin potentiation, accelerates healing of diabetic wounds such as diabetic foot ulcers and burn wounds. It reports an AQP3-dependent mechanism including increases in angiogenesis features such as microvascular density and eNOS, and increases in extracellular matrix production features including hydroxyproline/collagen, hyaluronic acid, and HAS1/HAS2.
It also reports enhanced reepithelialization and experimental support for the aquaporin/AQP3 mechanism using AQP3 inhibition and correlations, together with in vitro experiments in human keratinocytes and fibroblasts. High glucose downregulates AQP3 and EPO restores AQP3 and related proliferation, and a human case is described in which an EPO/fibronectin gel achieves complete closure of a chronic diabetic foot ulcer within about eight weeks, with reported local hyper-granulation and no major systemic effects.
Claims Coverage
The independent claim covers a method of treating a wound in a subject by administering a therapeutically effective composition that induces aquaporin expression, with erythropoietin protein and fibronectin protein at specified concentration ranges together with defined gel-formulation components. The claim includes a fully specified formulation, and dependent claims further narrow to specific concentration targets and gel form.
Aquaporin-inducing wound treatment composition
Administering to a subject a therapeutically effective amount of a composition that induces aquaporin expression to treat a wound.
Erythropoietin and fibronectin concentration ranges
Erythropoietin protein at a concentration of between 0.01% to 30% (w/w) and fibronectin protein at a concentration of between 0.01% to 50% (w/w).
Specified gel-formulation composition components
Glycerol at 5% (w/w), Carbomer 940 at 1% (w/w), benzyl alcohol at 2% (w/w), triethanolamine at about 0.9% (w/w), methylparaben at 0.2% (w/w), propylparaben at 0.05% (w/w), and water to 100% (w/w).
Gel administration limitation
The composition is a gel.
Fixed erythropoietin concentration embodiment
The erythropoietin protein is present at 5% (w/w).
Fixed fibronectin concentration and specified gel formulation embodiment
A fixed fibronectin protein concentration of 30% (w/w) along with glycerol, Carbomer 940, benzyl alcohol, triethanolamine, methylparaben, propylparaben, and water to 100% (w/w).
Overall, the claim set focuses on administering a therapeutically effective composition that induces aquaporin expression for wound treatment, using erythropoietin and fibronectin within specified concentration ranges together with defined gel-formulation components, and narrowing embodiments that specify particular erythropoietin and fibronectin concentrations and that the composition is a gel.
Stated Advantages
Accelerated healing of diabetic wounds, including diabetic foot ulcers and burn wounds.
Increased angiogenesis features including microvascular density and eNOS.
Increased extracellular matrix production including hydroxyproline/collagen, hyaluronic acid, and HAS1/HAS2.
Enhanced reepithelialization.
Complete closure of a chronic diabetic foot ulcer within about eight weeks, with reported local hyper-granulation and no major systemic effects.
Documented Applications
Treating diabetic wounds, including diabetic foot ulcers and burn wounds, using a topical erythropoietin (with fibronectin) gel.
Treatment of a chronic diabetic foot ulcer in a human case, with reported complete closure within about eight weeks and local hyper-granulation.
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