Compositions and methods for treating and preventing tissue injury and disease
Inventors
Peterson, Dale R. • Mattern, Ralph-Heiko • Wilson, Corey • Ohashi, Kevin L.
Assignees
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Publication Number
US-10617792-B2
Publication Date
2020-04-14
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 a composition comprising isolated multipotent cells in which the composition is sterilized. The composition comprises angiogenic or anti-inflammatory activity greater than saline alone while less than or equal to 50% of the cells in the composition are viable.
The described compositions include sterilized and/or virus-inactivated multipotent cells and processed microvascular tissue, and may be prepared as dried/lyophilized or cryopreserved formats with low or none viability. The bioactivity of angiogenic activity and/or anti-inflammatory activity is retained after sterilization and preservation.
The compositions may be provided in moisture-impermeable sealed containers or kits and can optionally include excipients and implantable scaffolds or matrices. The document describes functional characterization and in vivo outcomes showing retained chemoattraction/migration and improved blood-flow restoration in limb ischemia, vessel formation in a Matrigel-based assay context, and improved repair of tendon, bone, cartilage, and joint disease.
Claims Coverage
The independent claim is directed to a sterilized composition of isolated multipotent cells with angiogenic and/or anti-inflammatory activity greater than saline alone and a defined viability limit (≤50%).
Sterilized isolated multipotent cells with angiogenic or anti-inflammatory activity greater than saline
A composition comprising isolated multipotent cells, wherein the composition is sterilized, wherein the composition comprises angiogenic or anti-inflammatory activity greater than saline alone, and wherein less than or equal to 50% of the cells in the composition are viable.
Sterilization by irradiation with a dose greater than 0.5 Mrad
The claimed composition includes cells that have been sterilized by irradiation at a dose greater than 0.5 Mrad.
Viability constrained to 10% viable cells
The claim specifies a cell composition in which 10% of the cells are viable.
Substantially none of the cells are viable
The composition is defined such that substantially none of the cells present are viable.
Intravenous administration of the composition
The composition defined in claim 1 is formulated for intravenous administration.
Addition of an implantable scaffold or matrix
The claimed composition additionally includes an implantable scaffold or matrix.
Across the independent claim and dependent refinements provided, the central coverage is a sterilized multipotent-cell composition that retains angiogenic and/or anti-inflammatory activity above saline, with limited viability (≤50%, with further viability constraints in dependent claims), and optional context refinements including specific irradiation-based sterilization, intravenous administration, and optional implantable scaffold or matrix.
Stated Advantages
Angiogenic and/or anti-inflammatory activity greater than saline alone.
Retained functional angiogenic and/or anti-inflammatory bioactivity after sterilization and preservation.
Enhanced in vivo outcomes including improved blood-flow restoration, vessel formation, and improved repair of tendon, bone, cartilage, and joint disease.
Documented Applications
Treatment of ischemic injury and reperfusion injury, including limb ischemia (preclinical animal study context).
Promotion of vessel formation (e.g., Matrigel plug assay context).
Repair of tendon, including Achilles tendon injury (preclinical animal study context).
Repair of bone defects (preclinical animal study context, including critical-sized defects).
Repair of cartilage defects (preclinical animal study context).
Treatment of arthritis including osteoarthritis and rheumatoid arthritis (documented disease target).
Treatment of inflammation (documented disease target).
Treatment of microvascular injury and soft/hard tissue injury (documented injury targets).
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