Extracellular Matrix Prostheses for Treating Damaged Biological Tissue
Mufti-sheet laminate structures having a first extracellular matrix (ECM) sheet member having a top cross-linked surface and a second ECM sheet member having a bottom surface, the second ECM sheet member being joined to the first ECM sheet member, wherein the first ECM sheet member top cross-linked surface is disposed proximate the second ECM sheet member bottom surface.
1 . A vascular graft for treating damaged or diseased tissue in cardiovascular vessels, comprising:
a multi-sheet laminate structure comprising a first extracellular matrix (ECM) sheet member having a top cross-linked surface and a second ECM sheet member having top and bottom surfaces, said first ECM sheet member comprising first acellular ECM material, said second ECM sheet member comprising second acellular ECM material,
said second ECM sheet member being joined to said first ECM sheet member, wherein said first ECM sheet member top cross-linked surface is disposed proximate said second ECM sheet member bottom surface.
2 . The vascular graft of claim 1 , wherein said first ECM sheet member top cross-linked surface comprises a chemically induced cross-linked surface.
3 . The vascular graft of claim 1 , wherein said first ECM sheet member top cross-linked surface comprises an energy induced cross-linked surface.
4 . The vascular graft of claim 1 , wherein said first acellular ECM material is selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, omentum extracellular matrix, heart extracellular matrix and lung extracellular matrix.
5 . The vascular graft of claim 4 , wherein said first acellular ECM material comprises adolescent ECM material.
6 . The vascular graft of claim 1 , wherein said first ECM sheet member further comprises at least one exogenously added first biologically active agent.
7 . The vascular graft of claim 6 , wherein said first biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, and mesenchymal stem cell.
8 . The vascular graft of claim 6 , wherein said first biologically active agent comprises a growth factor selected from the group consisting of a transforming growth factor-alpha (TGF-α), transforming growth factor-beta (TGF-β), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), and vascular epithelial growth factor (VEGF).
9 . The vascular graft of claim 1 , wherein said first ECM sheet member further comprises at least a first pharmacological agent.
10 . The vascular graft of claim 9 , wherein said first pharmacological agent comprises an agent selected from the group consisting of an antibiotic, anti-viral agent, analgesic, anti-inflammatory, anti-neoplastic, anti-spasmodic, and anticoagulant and anti-thrombic agent.
11 . The vascular graft of claim 9 , wherein said first pharmacological agent comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.
12 . The vascular graft of claim 1 , wherein said second acellular ECM material is selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, omentum extracellular matrix, heart extracellular matrix and lung extracellular matrix.
13 . The vascular graft of claim 12 , wherein said second acellular ECM material comprises adolescent ECM material.
14 . The vascular graft of claim 1 , wherein said second ECM sheet member further comprises at least one exogenously added second biologically active agent.
15 . The vascular graft of claim 14 , wherein said second biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, and mesenchymal stem cell.
16 . The vascular graft of claim 14 , wherein said second biologically active agent comprises a growth factor selected from the group consisting of a transforming growth factor-alpha (TGF-α), transforming growth factor-beta (TGF-β), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), and vascular epithelial growth factor (VEGF).
17 . The vascular graft of claim 1 , wherein said second ECM sheet member further comprises at least a second pharmacological agent.
18 . The vascular graft of claim 17 , wherein said second pharmacological agent comprises an agent selected from the group consisting of an antibiotic, anti-viral agent, analgesic, anti-inflammatory, anti-neoplastic, anti-spasmodic, and anticoagulant and anti-thrombic agent.
19 . The vascular graft of claim 17 , wherein said second pharmacological agent comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.