Extracellular matrix (ECM) structures for tissue regeneration

• US 9,333,277 B2
• Filed: 06/17/2014
• Issued: 05/10/2016
• 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:
  US14/306,368
• Publication Number:
  US 20140336780A1
• Time in Patent Office: 693 Days
• Field of Search: 623/23.72, 424/443, 424/572
• US Class Current: 1/1
• 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

An extracellular matrix (ECM) structure for tissue regeneration, the ECM structure having a a sheet member comprising small intestine submucosa (SIS), the SIS sheet member being folded and laminated proximate the sheet member edge, wherein a folded laminated ECM structure having a cavity therein is formed, the ECM structure further including an ECM composition that is disposed in the ECM structure cavity, the ECM composition including liver basement membrane, urinary bladder submucosa, a mesenchymal stem cell and a growth factor.

Claims

1. An extracellular matrix (ECM) structure for tissue regeneration, comprising:

a sheet member comprising first acellular ECM from a first mammalian tissue source, said first mammalian tissue source comprising small intestine submucosa (SIS),

said SIS sheet member having a periphery, an edge that extends around said SIS sheet member periphery, a first end and an opposing second end, said SIS sheet member further including a mid-region that is disposed between said first and second ends,

said SIS sheet member being folded proximate said mid-region, wherein said first end is adjacent said second end, and laminated proximate said edge, wherein a folded laminated ECM structure having a cavity therein is formed,

said folded laminated ECM structure further comprising an ECM composition comprising second acellular ECM from a second mammalian tissue source, third acellular ECM from a third mammalian tissue source, a mesenchymal stem cell and a growth factor,

said second mammalian tissue source comprising liver basement membrane, said third mammalian tissue source comprising urinary bladder submucosa, said growth factor comprising fibroblast growth factor-2 (FGF-2),

said ECM composition being disposed in said folded laminated ECM structure cavity.

2. An extracellular matrix (ECM) structure for tissue regeneration, comprising:

a sheet member comprising first ECM, said first ECM comprising small intestine submucosa (SIS),

said SIS sheet member having a periphery, an edge that extends around said SIS sheet member periphery, a first end and an opposing second end, said SIS sheet member further including a mid-region that is disposed between said first and second ends,

said SIS sheet member being folded proximate said mid-region, wherein said first end is adjacent said second end, and laminated proximate said edge, wherein a folded laminated ECM structure having a cavity therein is formed,

said folded laminated ECM structure further comprising an ECM composition comprising second acellular ECM from a second mammalian tissue source, third acellular ECM from a third mammalian tissue source, a mesenchymal stem cell and a growth factor,

said second mammalian tissue source comprising liver basement membrane, said third mammalian tissue source comprising urinary bladder submucosa, said growth factor comprising a vascular epithelial growth factor (VEGF),

said ECM composition being disposed in said folded laminated ECM structure cavity.

3. An extracellular matrix (ECM) structure for tissue regeneration, comprising:

a sheet member comprising first ECM, said first ECM comprising small intestine submucosa (SIS),

said SIS sheet member having a periphery, an edge that extends around said SIS sheet member periphery, a first end and an opposing second end, said SIS sheet member further including a mid-region that is disposed between said first and second ends,

said SIS sheet member being folded proximate said mid-region, wherein said first end is adjacent said second end, and laminated proximate said edge, wherein a folded laminated ECM structure having a cavity therein is formed,

said folded laminated ECM structure further comprising an ECM composition comprising second acellular ECM from a second mammalian tissue source, third acellular ECM from a third mammalian tissue source, a pluripotent cell and a growth factor,

said second mammalian tissue source comprising liver basement membrane, said third mammalian tissue source comprising urinary bladder submucosa, said growth factor comprising fibroblast growth factor-2 (FGF-2),

said ECM composition being disposed in said folded laminated ECM structure cavity.

4. An extracellular matrix (ECM) structure for tissue regeneration, comprising:

a sheet member comprising first ECM, said first ECM comprising small intestine submucosa (SIS),

said SIS sheet member having a periphery, an edge that extends around said SIS sheet member periphery, a first end and an opposing second end, said SIS sheet member further including a mid-region that is disposed between said first and second ends,

said SIS sheet member being folded proximate said mid-region, wherein said first end is adjacent said second end, and laminated proximate said edge, wherein a folded laminated ECM structure having a cavity therein is formed,

said folded laminated ECM structure further comprising an ECM composition comprising second acellular ECM from a second mammalian tissue source, third acellular ECM from a third mammalian tissue source, a pluripotent cell and a growth factor,

said second mammalian tissue source comprising liver basement membrane, said third mammalian tissue source comprising urinary bladder submucosa, said growth factor comprising a vascular epithelial growth factor (VEGF),

said ECM composition being disposed in said folded laminated ECM structure cavity.