Compositions and methods for treating and preventing tissue injury and disease
Inventors
Peterson, Dale R. • Mattern, Ralph-Heiko • Wilson-Wirth, Corey • Ohashi, Kevin L.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9713629-B2
Publication Date
2017-07-25
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
Compositions and methods are described for allogeneic or xenogeneic treatment and/or prevention of tissue injury using uncultured, sterilized and/or virus-inactivated multipotent cells and/or processed microvascular tissue, including cell membranes, microvascular tissue, and extracellular matrix components. The compositions are prepared from a donor mammal and are processed so that the resulting composition retains measurable angiogenic and/or anti-inflammatory activity after processing and sterilization.
The problem addressed is to provide a processed tissue product for allogeneic or xenogeneic use that can be sterilized and/or inactivated for virus present in the composition while still retaining measurable angiogenic and/or anti-inflammatory activity. The processing described includes dissociating donor microvascular tissue, optionally removing one or more tissue components, and optionally filtering and separating undesired components such as adipocytes when the tissue is adipose-derived.
The processing further includes contacting microvascular tissue with one or more proteases for dissociation excluding collagenase, followed by dissociation or removal steps that include ultrasonic agitation, centrifugation, filtration, and/or use of a density gradient. Following removal, the composition can be optionally dried, lyophilized, or cryopreserved, and then sterilized and/or virus-inactivated, with the resulting composition retaining measurable angiogenic or anti-inflammatory activity.
Claims Coverage
The document explicitly provides one independent claim. It sets out a non-culturing preparation of processed microvascular tissue with sterilization and/or virus inactivation while retaining measurable angiogenic or anti-inflammatory activity.
Non-culturing preparation of angiogenic or anti-inflammatory processed microvascular tissue
A method of preparing a composition comprising processed microvascular tissue obtained from a donor mammal, where the cells or tissue are not cultured, the composition has angiogenic or anti-inflammatory activity, and the composition retains measurable angiogenic or anti-inflammatory activity after processing.
Dissociation of donor microvascular tissue using protease dissociation excluding collagenase
Dissociating a microvascular tissue sample to produce a composition comprising dissociated microvascular tissue by contacting the tissue sample with one or more proteases, wherein the one or more proteases does not comprise collagenase.
Selection of protease sets including collagenase type 1 with dispase or thermolysin and MMP 2, MMP 14 with dispase or thermolysin
Defining the one or more proteases to comprise or consist of collagenase type 1 and either dispase or thermolysin, or MMP 2, MMP 14 and either dispase or thermolysin.
Removal of tissue components and optional filtering or separation including adipocyte removal for adipose-derived tissue
Removing one or more tissue components from the dissociated composition and optionally filtering the composition; dissociation or removing further comprises ultrasonic agitation, centrifugation, filtration, or use of a density gradient; and when the microvascular tissue is adipose-derived, the ultrasonic agitation, centrifugation, filtration or use of a density gradient removes adipocytes from the composition.
Optional drying, lyophilizing, or cryopreserving with sterilization and virus inactivation
Optionally drying, lyophilizing, or cryopreserving the composition following removal steps, followed by sterilizing and/or inactivating virus present in the composition, where the resulting composition after the drying, lyophilizing, or cryopreserving and/or sterilization or inactivation retains measurable angiogenic or anti-inflammatory activity.
Across the independent claim, the main inventive theme is a non-culturing, donor-derived processed microvascular tissue composition that undergoes specified protease-based dissociation, selective component removal and optional filtration or separation including adipocyte removal for adipose-derived tissue, optional drying, lyophilizing, or cryopreserving, and sterilization and/or virus inactivation, while retaining measurable angiogenic or anti-inflammatory activity.
Stated Advantages
Retains measurable angiogenic or anti-inflammatory activity after processing and sterilization or inactivation.
Documented Applications
Treatment and/or prevention of tissue injury using allogeneic or xenogeneic processed microvascular tissue compositions.
Interested in licensing this patent?