Compositions and methods for treating and preventing tissue injury and disease

• US 10,729,729 B2
• Filed: 06/26/2017
• Issued: 08/04/2020
• Est. Priority Date: 09/19/2012
• Status: Active Grant

• Current Assignee: Microvascular Tissues, Inc.
• Original Assignee: Microvascular Tissues, Inc.
• Inventors: Peterson, Dale R., Mattern, Ralph-Heiko, Wilson-Wirth, Corey, Ohashi, Kevin L.
• Primary Examiner(s): Mi, Qiuwen
• Application Number:
  US15/633,311
• Publication Number:
  US 20170360845A1
• Time in Patent Office: 1,135 Days
• Field of Search: None
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/14 : Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
• CPC Class Codes: C12N 5/0653 : Adipocytes; Adipose tissue

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.

Claims

1. A method of preparing a composition comprising isolated multipotent cells, the method comprising:

(a) dissociating a tissue sample obtained from a donor mammal to release a plurality of multipotent cells therein;

(b) separating a plurality of released multipotent cells from one or more other tissue components to produce a composition comprising isolated multipotent cells; and

(c) sterilizing the composition resulting from (b),

wherein the composition resulting from the method retains angiogenic or anti-inflammatory activity,

wherein the tissue is adipose-derived tissue, bone marrow, bone, muscle tissue, umbilical cord tissue, or amniotic tissue.

2. The method of claim 1, wherein the method comprises (d) drying, lyophilizing, or cryopreserving the composition.

3. The method of claim 1, wherein the method comprises (d) inactivating virus in the composition.

4. The method of claim 1, wherein the method comprises:

(d) filtering the composition

(e) drying, lyophilizing, or cryopreserving the composition; and

(f) inactivating virus in the composition,

wherein dissociating step (a) comprises contacting the tissue sample with one or more protease, and wherein the one or more proteases does not comprise collagenase.

5. The method of claim 4, wherein the plurality of released multipotent cells are not cultured.

6. A method of preparing a composition comprising processed microvascular tissue, the method comprising:

(a) dissociating a microvascular tissue sample obtained from a donor mammal to produce a composition comprising dissociated microvascular tissue;

(b) removing one or more tissue components from the composition produced according to (a); and

(c) sterilizing the composition following (b),

wherein the composition resulting from the method retains angiogenic or anti-inflammatory activity,

wherein the tissue is adipose-derived tissue, bone marrow, bone, muscle tissue, umbilical cord tissue, or amniotic tissue.

7. The method of claim 6, wherein the method comprises (d) drying, lyophilizing, or cryopreserving the composition.

8. The method of claim 6, wherein the method comprises (d) inactivating virus in the composition.

9. The method of claim 6, wherein the method comprises:

(d) filtering the composition

(e) drying, lyophilizing, or cryopreserving the composition; and

(f) inactivating virus in the composition,

wherein dissociating step (a) comprises contacting the tissue sample with one or more protease, and wherein the one or more proteases does not comprise collagenase.

10. The method of claim 9, wherein the plurality of released multipotent cells are not cultured.