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-12364716-B2
Publication Date
2025-07-22
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 provides sterilized and/or virus-inactivated allogeneic compositions using isolated multipotent cells and/or processed microvascular tissue or cell membranes derived from dissociated mammalian tissue. The compositions are prepared so that cell viability is reduced or absent, including uncultured cells and non-viable or substantially nonviable cell populations, while retaining measurable angiogenic and/or anti-inflammatory activity after processing and storage.
The compositions include sterilization by irradiation and optional viral inactivation. Processing involves dissociation of mammalian tissue, separation, optional drying, lyophilization, or cryopreservation, sterilization, and viral inactivation, and the resulting compositions are formulated with excipients and provided in moisture-impermeable containers or kits.
The invention further encompasses compositions combined with implantable scaffolds or matrices, including bone-derived implants, biofiber scaffolds, hydrogels, and sutures, and used as injectable and/or implantable therapies in an allogeneic setting. The disclosed functionality includes angiogenic activity such as attracting endothelial cells and supporting vessel-related outcomes, as well as anti-inflammatory activity, with applications described for ischemic injury, tendon injury, arthritis, and diabetic foot ulcer healing.
Claims Coverage
The partial claims include two independent claims. Each independent claim defines a sterilized or virus-inactivated composition derived from mammalian tissue that exhibits angiogenic or anti-inflammatory activity, with a distinction between viable multipotent cells and rendered nonviable multipotent cells.
Sterilized multipotent-cell composition with angiogenic or anti-inflammatory activity
A composition comprising enriched or isolated multipotent cells from dissociated mammalian tissue, wherein the composition is sterilized by irradiation, and wherein the composition has angiogenic or anti-inflammatory activity.
Nonviable multipotent-cell composition from dissociated tissue with angiogenic or anti-inflammatory activity
A composition comprising dissociated mammalian tissue, wherein the composition comprises multipotent cells rendered nonviable, and wherein the composition has angiogenic or anti-inflammatory activity.
Across the independent claims, the core coverage is compositions derived from dissociated mammalian tissue that contain multipotent cells, with the composition exhibiting angiogenic or anti-inflammatory activity, including irradiation sterilization and optional virus inactivation.
Stated Advantages
Reduced immune response/rejection risk for allogeneic use.
Sterility and viral safety due to sterilization and optional virus inactivation.
Unexpected therapeutic efficacy despite low viability.
Documented Applications
Diabetic foot ulcer use, including reported wound-healing and neuropathy improvements with topical and injectable processed multipotent cell compositions.
Soft tissue injury repair contexts including tendon/ligament injury, exemplified by Achilles tendon injury repair outcomes in a described model.
Ischemic injury contexts, including improved blood flow and repair outcomes described for mouse limb ischemia models.
Inflammation and arthritis contexts, exemplified by rheumatoid arthritis outcomes described for a type II collagen setting.
Bone/cartilage/meniscus defect repair contexts, exemplified by defects described in goats.
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