Methods of using regenerative cells in the treatment of stroke and related diseases and disorders

• US 9,511,094 B2
• Filed: 08/15/2012
• Issued: 12/06/2016
• Est. Priority Date: 12/07/2001
• Status: Expired due to Term

• Current Assignee: Lorem Vascular Pte. Ltd.
• Original Assignee: Cytori Therapeutics Incorporated
• Inventors: Fraser, John K., Hedrick, Marc H., Strem, Brian M.
• Primary Examiner(s): Gitomer, Ralph
• Assistant Examiner(s): CLARKE, TRENT R
• Application Number:
  US13/586,735
• Publication Number:
  US 20120308518A1
• Time in Patent Office: 1,574 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61K 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• 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: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 : of the kidneys
• 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 21/00 : Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/02 : Ophthalmic agents
• CPC Class Codes: A61P 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• 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: C12N 2506/1384 : from adipose-derived stem cells [ADSC], from adipose stromal stem cells
• CPC Class Codes: C12N 5/0667 : Adipose-derived stem cells [ADSC]; Adipose stromal stem cells
• CPC Class Codes: C12N 5/069 : Vascular Endothelial cells

Abstract

Cells present in adipose tissue are used to stroke and stroke related diseases and disorders in a patient. Methods of treating patients include processing adipose tissue to deliver a concentrated amount of regenerative cells obtained from the adipose tissue to a patient. The methods may be practiced in a closed system so that the regenerative cells are not exposed to an external environment prior to being administered to a patient. Accordingly, in a preferred method, cells present in adipose tissue are placed directly into a recipient along with such additives necessary to promote, engender or support a therapeutic benefit.

Claims

1. A method of alleviating at least one adverse effect of stroke in a patient in need of an increased blood flow to an ischemic region comprising:

identifying a patient in need of an increased blood flow to an ischemic region, wherein said patient has at least one symptom of stroke; and

providing to said patient an amount of an autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells sufficient to increase blood flow to said ischemic region and alleviate said symptom of stroke wherein said concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells has not been cultured.

2. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells is provided by intravenous infusion.

3. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells provided is within a range of about 1×

10⁵ cells/ml to about 1×

10⁷ cells/ml.

4. The method of claim 1, further comprising performing a neurologic examination of said patient.

5. The method of claim 1, further comprising performing an MRI on said patient.

6. The method of claim 1, further comprising performing doppler imaging on said patient.

7. The method of claim 1, wherein said stroke is an ischemic stroke.

8. The method of claim 1, wherein said autologous concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells further comprises an additive selected from the group consisting of bFGF, HGF, IL-6, and IL-13.

9. The method of claim 1, wherein said autologous concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells further comprises a cellular re-aggregation inhibitor or a disaggregation agent.

10. The method of claim 1, wherein the autologous concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells are provided via a subcutaneous, intra-carotid artery, intra-arterial, intrathecal or intra-parenchymal delivery route.

11. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells are administered in a bolus.

12. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells are administered in multiple doses.

13. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells are separated from mature adipocytes and connective tissue.

14. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells further comprises a neurogenic factor.

15. The method of claim 1, wherein the autologous, concentrated, heterogeneous population of cells comprising adipose-derived stem cells and progenitor cells is cryopreserved.