Allogeneic microvascular tissue for soft tissue treatments
Inventors
Peterson, Dale R. • Emmitt, Richard B.
Assignees
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Publication Number
US-11376348-B2
Publication Date
2022-07-05
Expiration Date
Abstract
Disclosed are products and methods for treating soft tissue injuries. The provided methods include the production of processed or cryopreserved microvascular tissue. Also provided are products and methods of using processed or cryopreserved microvascular tissue for the treatment of soft tissue injuries.
Core Innovation
The invention relates to off-the-shelf allogeneic or xenogeneic microvascular tissue products for soft-tissue repair and hard-tissue healing. The microvascular tissue is minimally processed as an uncultured, dissociated mixture of stem and/or progenitor cells together with other molecules, and is then dried, including freeze-drying or spray-drying, or cryopreserved.
Tissue healing activity is attributed to intact cell membranes and does not rely on maintained cell viability. After processing, viability drops, including to substantially no viable cells, while cell membranes remain generally intact. The disclosed compositions include dissociated stem or progenitor cells that have been lyophilized and contain less than 30% viable cells, yet have tissue healing activity and intact cell membranes.
The disclosure further addresses microbial contamination prevention and removal of undesired components, including red blood cells, lipids, and adipocytes. It describes selection of excipients for preservation and preservation stability at room temperature for at least a month, with use formats including direct application, reconstitution, scaffold coating or impregnation, and combination with orthopedic and surgical implants.
Claims Coverage
The independent claim set is directed to a composition of dissociated and then dried stem or progenitor cells that exhibits tissue healing activity despite low viability, with intact cell membranes, and where the cells are lyophilized. One independent claim is explicitly identified in the provided claim set, and the dependent claims add further constraints on viability, drying format, sourcing relative to a recipient, and removal of undesired cells or molecules.
Lyophilized dissociated stem or progenitor cells with intact membranes and tissue healing activity
A composition comprising a plurality of dissociated and then dried stem or progenitor cells, wherein the plurality contains less than 30% viable cells, wherein the composition has tissue healing activity, wherein the plurality has intact cell membranes, and wherein the plurality has been lyophilized.
Composition with no viable cells
The composition in which the plurality of stem or progenitor cells contains no viable cells.
Spray-dried dissociated stem or progenitor cells
The composition in which the plurality of stem or progenitor cells is spray-dried.
Xenogeneic stem or progenitor cells to a recipient
The composition in which the plurality of stem or progenitor cells is xenogeneic to a recipient.
Allogeneic stem or progenitor cells to a recipient
The composition in which the plurality of stem or progenitor cells is allogeneic to a recipient.
Removal of undesired cells or molecules
The composition further involving treating a plurality of stem or progenitor cells to remove undesired cells or molecules.
Overall, the claim coverage centers on dried, including lyophilized, dissociated stem or progenitor cells having intact cell membranes and tissue healing activity while containing less than 30% viable cells, with dependent claims tightening viability to no viable cells, narrowing drying to spray-drying, specifying xenogeneic or allogeneic sourcing, and adding treatment to remove undesired cells or molecules.
Stated Advantages
Tissue healing activity is achieved with substantially reduced viability, including less than 30% viable cells and optionally no viable cells.
Cell membranes remain intact after processing while viability drops.
Stability at room temperature for at least a month is described.
Microbial contamination prevention is described.
Undesired components can be removed, including red blood cells, lipids, and adipocytes.
Documented Applications
Soft-tissue repair including tendon, ligament, and skin is described.
Hard-tissue healing is described.
Use in an orthopedic or surgical implant combination is described.
Example use in a rat Achilles tendon injury model is described, with improved tissue invasion or approximation and evidence of new tendon formation.
Application formats include direct application, reconstitution, scaffold coating or impregnation, and combination with orthopedic or surgical implants.
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