Mesenchymal stem cell (MSC) growth factor and extracellular vesicle preparation in frozen or powdered form and methods of use

Inventors

MOSELEY, Timothy Alexander • Pettine, Kenneth Allen

Assignees

Direct Biologics LLC

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Publication Number

US-12453743-B2

Patent

Publication Date

2025-10-28

Expiration Date


Abstract

Disclosed are mesenchymal stem cell growth factor compositions and methods of their use to treat skin disorder, alleviate the effects of aging, treat wounds, orthopedic disorders, sexual dysfunction and/or reduce inflammation.

Core Innovation

The invention relates to an acellular MSC secretome/growth-factor system prepared from cultured mesenchymal stem cells and formulated as frozen and/or lyophilized powders. The compositions include MSC-derived anti-inflammatory proteins, growth factors, ECM/proteoglycans/glycosaminoglycans, and extracellular vesicles/exosomes, and they are configured for human administration in a powdered form.

A further aspect is the use of culture conditions intended to generate an MSC secretome with anti-inflammatory activity, including standard hyperoxic culture conditions and artificial wound-healing hypoxic/inflammatory conditions. The description links the resulting secretome/growth-factor profile to culture parameters such as oxygen, glucose, pH, temperature, and stiffness, together with the intention that the therapeutically effective amount is sufficient to reduce inflammation in a human.

The documented examples in the partial content include growth factors in the MSC secretome such as EGF, BMPs, HGF, VEGF, and IL-6. The compositions are additionally described as being formulated with protective cryoprotectant/protective coatings, including oligosaccharides and protective polymer/protective matrices, and may include MSC-derived extracellular vesicles with specified size ranges.

The compositions and their described use are directed to treating skin disorders, wounds, orthopedic/spinal conditions, autoimmune and autoinflammatory diseases, physical injuries, sexual dysfunction, and inflammatory pain. The partial content also indicates related preparation forms such as MSC extracts and MSC lysates, and it frames the approach as providing an acellular, MSC-derived therapeutic composition for reducing inflammation.

Claims Coverage

The partial content provides one independent claim (clm-00001). The inventive features center on a human-administered powdered, acellular MSC secretome containing a specified set of growth factors and formulated so that a therapeutically effective amount reduces inflammation, with dependent claims refining the secretome composition content, vesicle size range, and optional excipients.

Powdered acellular human MSC secretome for inflammation reduction

A pharmaceutical acellular composition for human administration comprising a therapeutically effective amount of a human bone marrow mesenchymal stem cell (MSC) secretome comprising epidermal growth factor (EGF), bone morphogenetic protein 1 (BMP-1), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), and interleukin-6 (IL-6), wherein the therapeutically effective amount is sufficient to reduce inflammation in the human, wherein the pharmaceutical acellular composition is in a powdered form.

Across the provided claim set, the coverage is anchored by a powdered, acellular pharmaceutical composition for human administration that uses a human bone marrow MSC secretome containing EGF, BMP-1, HGF, VEGF, and IL-6 in a therapeutically effective amount sufficient to reduce inflammation. Dependent claims in the partial set further specify secretome content constraints, extracellular vesicle size ranges, a secreted-and-separated secretome preparation characteristic, and optional sugar excipients.

Stated Advantages

Reduces inflammation in the human when administered as a therapeutically effective amount.

Documented Applications

Treatment of skin disorders.

Treatment of wounds.

Treatment of orthopedic/spinal conditions.

Treatment of autoimmune diseases.

Treatment of autoinflammatory diseases.

Treatment of physical injuries.

Treatment of sexual dysfunction.

Treatment of inflammatory pain.

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