Methods of treating inflammatory bowel disease with AMD3100 and tacrolimus

• US 10,420,751 B2
• Filed: 07/31/2015
• Issued: 09/24/2019
• Est. Priority Date: 12/11/2009
• Status: Active Grant

• Current Assignee: Medregen, LLC
• Original Assignee: Medregen, LLC
• Inventors: Sun, Zhaoli, Li, Xuhang
• Primary Examiner(s): Gambel, Phillip
• Application Number:
  US14/814,988
• Publication Number:
  US 20160008331A1
• Time in Patent Office: 1,516 Days
• Field of Search: None
• 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 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/365 Lactones
• CPC Class Codes: A61K 31/395 having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/4427 containing further heterocyclic ring systems
• CPC Class Codes: A61K 31/506 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/19 Cytokines; Lymphokines; Interferons
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/107 Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients
• CPC Class Codes: A61K 9/4841 Filling excipients; Inactive ingredients
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 13/12 : of the kidneys
• CPC Class Codes: A61P 17/00 : Drugs for dermatological disorders
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• 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

Abstract

The present invention relates to the field of inflammatory bowel disease. In one aspect, the present invention provides methods for treating inflammatory bowel disease in a patient comprising administering to the patient a therapeutically effective amount of a stem cell mobilizer and an immunosuppressive agent. In particular embodiments, the present invention provides a method for treating inflammatory bowel disease in a patient comprising administering to the patient a therapeutically effective amount of an agent that mobilizes CD34⁺ and/or CD133⁺ stem cells and a low dose of an immunosuppressive agent.

Claims

1. A method of treating inflammatory bowel disease in a patient comprising administering to the patient a therapeutically effective amount of a stem cell mobilizer and an immunosuppressive agent,

wherein the stem cell mobilizer is AMD3100,

the immunosuppressive agent is Tacrolimus, and

the stem cell mobilizer and the immunosuppressive agent are administered once every two days,

wherein the administration of the stem cell mobilizer and the immunosuppressive agent improves mucosal healing and decreases colonic inflammation, and

wherein the immunosuppressive agent is administered to the patient in an amount of 0.004 mg/kg to 0.008 mg/kg.

2. A method of treating inflammatory bowel disease in a patient comprising administering to the patient a therapeutically effective amount of an agent that mobilizes CD34⁺ and/or CD133⁺ stem cells and an immunosuppressive agent, wherein the agent that mobilizes CD34⁺ and/or CD133⁺ stem cells is AMD3100, the immunosuppressive agent is Tacrolimus, and

the agent that mobilizes CD34⁺ and/or CD133⁺ stem cells and the immunosuppressive agent are administered once every two days,

wherein administration of the agent that mobilizes CD34⁺ and/or CD133⁺ stem cells and the immunosuppressive agent improves mucosal healing and decreases colonic inflammation, and

wherein the immunosuppressive agent is administered in an amount of 0.004 mg/kg to 0.008 mg/kg.