Method and system for treatment of cardiovascular disorders

• US 9,119,899 B2
• Filed: 03/01/2013
• Issued: 09/01/2015
• Est. Priority Date: 01/18/2006
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert
• Primary Examiner(s): LEAVITT, MARIA GOMEZ
• Application Number:
  US13/782,115
• Publication Number:
  US 20140088339A1
• Time in Patent Office: 914 Days
• Field of Search: 424/484, 424/423, 424/520, 424/551, 435/387, 435/395
• US Class Current: 1/1
• 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 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61K 38/185 Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
• 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 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/434 of enzymes
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• 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 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/367 Muscle tissue, e.g. sphincter
• CPC Class Codes: A61L 27/3826 Muscle cells, e.g. smooth muscle cells
• 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: A61M 2205/05 : combined with other kinds of therapy
• CPC Class Codes: A61M 60/148 : in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Abstract

Methods for treating a cardiovascular disorder comprising concomitant administration of one or more extracellular matrix (ECM) based compositions directly to damaged or diseased cardiovascular tissue associated with the cardiovascular disorder, and provision of ventricular assistance. In a preferred embodiment, the ECM based compositions include an ECM material derived from a mammalian source.

Claims

1. A method of treating ischemic heart disease of a subject, the ischemic heart disease presenting with ischemic infarcted cardiovascular tissue, the method comprising the steps of:

providing an extracellular matrix (ECM) composition comprising acellular small intestine submucosa (SIS), said ECM composition further comprising 0.1 μ

M of cerivastatin wherein the cerivastatin is mixed with the ECM composition;

providing a mechanical circulatory support (MSC) device that is configured to support ventricular function of a mammalian heart when connected thereto;

connecting said MSC device to said subject'"'"'s circulatory system;

administering said ECM composition proximate said ischemic infarcted cardiovascular tissue of said subject'"'"'s heart, wherein said ECM composition inhibits localized expression of proinflammatory chemokine monocyte chemoattractant protein-1 (MCP-1) and proinflammatory receptor C—

C chemokine receptor type-2 (CCR2),

whereby inflammation of said infarcted cardiovascular tissue is reduced and bioremodeling and regeneration of new cardiovascular tissue is induced; and

providing support of ventricular function of said subject'"'"'s heart with said MSC device, wherein said heart exhibits a post-treatment ejection fraction, said post-treatment ejection fraction being greater relative to said heart'"'"'s ejection fraction by providing said MSC or administration of said ECM composition alone.

2. The method of claim 1, wherein said ECM composition is administered directly to said ischemic infarcted cardiovascular tissue.

3. The method of claim 1, wherein said MSC device comprises a left ventricular assist device (LVAD).

4. The method of claim 1, wherein said MSC device comprises a right ventricular assist device (RVAD).