Compositions and methods for treating and preventing tissue injury and disease
Inventors
Peterson, Dale R. • Mattern, Ralph-Heiko • Ohashi, Kevin L. • PICKETT, Lael J. • Gong, Glen • El-Kalay, Mohammad A.
Assignees
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Publication Number
US-11246891-B2
Publication Date
2022-02-15
Expiration Date
Abstract
The present invention provides novel compositions comprising multipotent cells or microvascular tissue, wherein the cells or tissue has been sterilized and/or treated to inactivated viruses, and related methods of using these compositions to treat or prevent tissue injury or disease in an allogeneic subject.
Core Innovation
The invention describes compositions and therapeutic methods for treating an injury in a subject by administering a therapeutic agent. The therapeutic agent comprises enriched, sterilized multipotent cells, and in one aspect the sterilized multipotent cells are sterilized by irradiation.
In another aspect, the therapeutic agent comprises enriched, sterilized multipotent cells that are nonviable. The invention further relates to multipotent cells associated with processed microvascular tissue, including cell membranes, and provides preparations that can be sterilized and/or virus inactivated, optionally without culturing.
The invention also describes preservation and storage formats for the multipotent cell therapeutic agent, including dry/lyophilized and cryopreserved forms, with retained angiogenic and anti-inflammatory activity during storage. The therapeutic agent can be formulated for use with implantable scaffolds or matrices, and is described for local administration and other delivery formats depending on the injury.
Claims Coverage
The partial content identifies two independent claims. Together, they cover therapeutic treatment of an injury using enriched, sterilized multipotent cells, with the inventive distinguishing elements being irradiation sterilization versus nonviable sterilized multipotent cells.
Treating an injury with irradiation-sterilized enriched multipotent cells
A method of treating an injury in a subject in need thereof by administering a therapeutic agent comprising enriched, sterilized multipotent cells, wherein the multipotent cells are sterilized by irradiation.
Treating an injury with nonviable enriched sterilized multipotent cells
A method of treating an injury in a subject in need thereof by administering a therapeutic agent comprising enriched, sterilized multipotent cells, wherein the sterilized multipotent cells are nonviable.
Claim coverage is centered on injury treatment via administration of a therapeutic agent containing enriched, sterilized multipotent cells, with irradiation-based sterilization as a first independent approach and nonviability of the sterilized multipotent cells as a second independent approach.
Stated Advantages
Reduced immune response or rejection risk.
Anti-inflammatory and angiogenic effects despite nonviable cells.
Ready-to-use stability via preservation formats such as dry/lyophilized and cryopreserved preparations.
Documented Applications
Treatment of diabetic foot ulcers with topical or local administration, including improvement in wound healing and neuropathy.
Treatment of ischemic mouse models, including angiogenesis and restoration of blood flow.
Repair of bone, cartilage, and tendon injury in animal models.
In vitro angiogenic activity and endothelial migration and microvesicle uptake assays indicating angiogenic activity without viable cells.
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