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-11819522-B2
Publication Date
2023-11-21
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 relates to compositions comprising isolated microvascular tissue that undergoes sterilization. The compositions are described in connection with allogeneic treatment of tissue injury/disease in an allogeneic subject and, in some embodiments, for xenogeneic subject treatment. Sterilization is described as being performed while maintaining activity relevant to tissue repair.
The compositions are described as sterilized and/or virus-inactivated multipotent cells and/or processed microvascular tissue, including cell membranes and extracellular matrix components. The preparation is described as preserving angiogenic activity and anti-inflammatory activity despite reduced viability or non-viability, including embodiments involving uncultured cells.
The microvascular tissue is described as isolated and processed using tissue dissociation and separation/removal steps, including adipocyte removal, and optional protease systems, filtration, and sterilization by irradiation and/or virus inactivation. The compositions are further described as formulated with excipients and optionally implantable scaffolds or matrix components such as hydrogels, porous resorbable polymer materials, bone-derived implants, biofiber scaffolds, or sutures, to support tissue repair.
Claims Coverage
The independent claim is directed to a sterilized composition comprising isolated microvascular tissue, and the dependent claims refine the sterilization and specify preserved biological activities and further tissue and delivery/formulation details.
Sterilization of isolated microvascular tissue composition
A composition comprising isolated microvascular tissue, wherein the composition undergoes sterilization.
Irradiation at dose greater than 0.5 Mrad
The composition is characterized such that the isolated microvascular tissue composition undergoes irradiation at a dose greater than 0.5 Mrad.
Retaining angiogenic activity after sterilization
The composition is further specified to retain angiogenic activity.
Isolated microvascular tissue with removal or lysis of adipocytes
The isolated microvascular tissue includes removal or lysis of adipocytes.
Gel suitable for topical delivery
The composition is characterized as a gel formulated so it is suitable for topical delivery.
Administering sterilized microvascular tissue composition for soft-tissue injury
Treating a soft-tissue injury in a subject by administering the composition.
The claim set covers a sterilized composition of isolated microvascular tissue, refined by irradiation dose constraints and by preservation of angiogenic activity, and further narrowed by adipocyte removal or lysis and specific delivery or formulation forms, including topical gels, with treatment of soft-tissue injury described for administration of the composition.
Stated Advantages
Preservation of angiogenic activity despite sterilization.
Preservation of anti-inflammatory activity despite reduced viability or non-viability.
Ready-to-use formats including dried and/or lyophilized and/or cryopreserved compositions in moisture-impermeable containers.
Documented Applications
Allogeneic treatment of tissue injury/disease using sterilized and/or virus-inactivated multipotent cells and/or processed microvascular tissue.
Treatment of soft-tissue injuries in a subject using the composition.
Treatment of tendon/cartilage/bone defects and tissue repair across soft/hard tissue injuries and diseases, including ischemia, arthritis such as osteoarthritis and rheumatoid arthritis, and neuropathy/diabetic foot ulcer.
Animal tissue repair applications described for tendon/cartilage/bone repair, including goats and rats, and blood flow restoration in an ischemia model.
Patient applications described as topical DFU/neuropathy improvements.
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