Formulation for storage, transportation, and delivery of protein rich conditioned medium

Inventors

Park, Hyeonggeun • Khoury, Fred Haisam

Assignees

Hope Biosciences LLC

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Publication Number

US-10988731-B2

Patent

Publication Date

2021-04-27

Expiration Date


Abstract

A method of creating a protein rich conditioned medium. The method includes culturing mesenchymal stem cells in a container utilizing a first growth medium, allowing a time period for proliferation of the mesenchymal stem cells until a desired level of confluence is achieved in the container, discarding a supernatant from the container, adding a second medium to the container, incubating the mesenchymal stem cells, and collecting the conditioned medium. The method produces significantly higher quantities of byproducts secreted by the mesenchymal stem cells. Byproducts are usable for wound healing, disease treatment, cosmetic, or other beneficial effects when applied or otherwise delivered to a patient.

Core Innovation

The invention relates to a storage, transportation, and delivery formulation comprising a protein rich conditioned medium. The conditioned medium contains fibroblast growth factor (FGF), transforming growth factor (TGF), epidermal growth factor (EGF), and stromal-derived factor (SDF), and the conditioned medium is not concentrated, with EGF present in at least twenty times the concentration of FGF.

The conditioned medium is combined with water and formulation components including disodium ethylenediaminetetraacetic acid, propanediol, phenoxyethanol, C12-15 alkyl benzoate, and polyacrylate Crosspolymer-6. The formulation is designed to package the protein rich conditioned medium for storage, transportation, and delivery while maintaining the conditioned medium in a non-concentrated form.

The invention also covers a method for creating the storage, transportation, and delivery formulation. The method includes culturing mesenchymal stem cells, collecting a conditioned medium meeting the defined FGF, TGF, EGF, and SDF concentrations, and combining the conditioned medium with water and the specified excipients within defined concentration ranges, resulting in a formulation that forms an emulsion for storage, transportation, and delivery of the conditioned medium.

Claims Coverage

Two independent claims are provided, one directed to a composition and one directed to a method. Across these claims, the coverage centers on a non-concentrated, protein rich mesenchymal stem cell conditioned medium with defined growth factor concentrations and ratios, formulated with a defined set of excipients that produce an emulsion for storage, transportation, and delivery.

Protein rich conditioned medium formulation for storage, transportation, and delivery

A storage, transportation, and delivery formulation comprising a protein rich conditioned medium, wherein the conditioned medium comprises at least 0.3 pg/ml fibroblast growth factor (FGF), 6 pg/ml transforming growth factor (TGF), 6 pg/ml epidermal growth factor (EGF) with EGF present in at least twenty times the concentration of fibroblast growth factor (FGF), and 300 pg/ml stromal-derived factor (SDF), combined with water, disodium ethylenediaminetetraacetic acid, propanediol, phenoxyethanol, C12-15 alkyl benzoate, and polyacrylate Crosspolymer-6, and wherein the conditioned medium is not concentrated.

Emulsion-forming method using non-concentrated conditioned medium

A method of creating a storage, transportation, and delivery formulation comprising a protein rich conditioned medium, comprising culturing mesenchymal stem cells; collecting a conditioned medium comprising at least 0.3 pg/ml fibroblast growth factor (FGF), 6 pg/ml transforming growth factor (TGF), 6 pg/ml epidermal growth factor (EGF) with EGF present in at least twenty times the concentration of fibroblast growth factor (FGF), and 300 pg/ml stromal-derived factor (SDF); and combining the conditioned medium with water, disodium ethylenediaminetetraacetic acid, propanediol, phenoxyethanol, C12-15 alkyl benzoate, and polyacrylate crosspolymer-6, wherein the conditioned medium is not concentrated and the formulation forms an emulsion for storage, transportation, and delivery.

The independent claim coverage is anchored by a non-concentrated conditioned medium defining FGF, TGF, EGF, and SDF concentrations, with EGF at least twenty times FGF, and by formulation into a storage, transportation, and delivery emulsion using water with disodium ethylenediaminetetraacetic acid, propanediol, phenoxyethanol, C12-15 alkyl benzoate, and polyacrylate Crosspolymer-6.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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