Laminate sheet articles for tissue regeneration

• US 8,758,448 B2
• Filed: 02/23/2011
• Issued: 06/24/2014
• Est. Priority Date: 05/10/2007
• Status: Active Grant

• Current Assignee: Elutia Med LLC
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G.
• Primary Examiner(s): Chen, Shin Lin
• Application Number:
  US13/033,102
• Publication Number:
  US 20120016491A1
• Time in Patent Office: 1,217 Days
• Field of Search: 623/23.72
• US Class Current: 623/23.72
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 35/22 Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
• 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 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 38/005 Enzyme inhibitors protease inhibitors A61K38/55
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• 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 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3679 Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: C07K 14/435 from animals; from humans
• CPC Class Codes: C12N 5/068 Stem cells; Progenitors

Abstract

The invention is to articles of extracellular matrix. The articles comprise one or more sheets of mammalian extracellular matrix laminated together. A single sheet can be folded over and laminated on 3 sides. Two or more sheets can be laminated to each other at their edges. The sheets can further encase a composition comprising a cell or cells, such as for example, a stem cell. A single sheet can be folded over to encase a composition, or rolled to encase a composition with lamination at either end of the roll, for example. The invention also includes methods of using these articles to regenerate tissue at tissue defects, or heal wounds in damaged tissue.

Claims

1. An article for wound healing and tissue regeneration, comprising:

a first sheet comprising a first mammalian extracellular matrix and a second sheet comprising a second mammalian extracellular matrix, said first and second extracellular matrices comprising small intestine submucosa, said first extracellular matrix sheet having a first outer edge, said second extracellular matrix sheet having a second outer edge, said first and second extracellular matrix sheets being laminated to each other proximate said first and second edges to form a laminated article having a cavity therein, said article further comprising an extracellular matrix composition comprising a third extracellular matrix comprising liver basement membrane, a fourth extracellular matrix comprising urinary bladder submucosa, a cell comprising a mesenchymal stem cell and a protein comprising a growth factor, said growth factor comprising fibroblast growth factor-2 (FGF-2) vascular epithelial growth factor (VEGF), and said extracellular matrix composition being disposed in said article cavity.

2. The article of claim 1, wherein said growth factor comprises a vascular epithelial growth factor (VEGF).

3. An article for wound healing and tissue regeneration, comprising:

a first sheet comprising a first mammalian extracellular matrix and a second sheet comprising a second mammalian extracellular matrix, said first and second extracellular matrices comprising small intestine submucosa, said first extracellular matrix sheet having a first outer edge, said second extracellular matrix sheet having a second outer edge, said first and second extracellular matrix sheets being laminated to each other proximate said first and second edges to form a planar laminated article having a cavity therein, said article further comprising an extracellular matrix composition comprising a third extracellular matrix comprising liver basement membrane, a fourth extracellular matrix comprising urinary bladder submucosa, a cell comprising a pluripotent cell and a protein comprising a growth factor, said growth factor comprising fibroblast growth factor-2 (FGF-2) vascular epithelial growth factor (VEGF), and said extracellular matrix composition being disposed in said article cavity.

4. The article of claim 3, wherein said growth factor comprises a vascular epithelial growth factor (VEGF).