Enhanced submucosal tissue graft constructs

• US 7,771,717 B2
• Filed: 02/13/2007
• Issued: 08/10/2010
• Est. Priority Date: 02/10/1995
• Status: Expired due to Term

• Current Assignee: Clarian Health Partners, Inc., Purdue Research Foundation (Purdue University)
• Original Assignee: Clarian Health Partners, Inc., Purdue Research Foundation (Purdue University)
• Inventors: Lindberg, Khristina, Badylak, Stephen F., Boder, George B., Voytik-Harbin, Sherry
• Primary Examiner(s): FOX, ALLISON M
• Application Number:
  US11/705,847
• Publication Number:
  US 20070141037A1
• Time in Patent Office: 1,274 Days
• Field of Search: None
• US Class Current: 424/93.7
• 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 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• 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 27/3641 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 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3808 Endothelial 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: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12N 2500/32 Amino acids
• CPC Class Codes: C12N 2500/38 Vitamins
• CPC Class Codes: C12N 2533/92 Amnion; Decellularised dermis or mucosa
• CPC Class Codes: C12N 5/0068 General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: C12N 5/0655 Chondrocytes; Cartilage
• CPC Class Codes: C12N 5/0676 Pancreatic cells
• CPC Class Codes: C12N 5/0679 Cells of the gastro-intestinal tract

Abstract

An improved tissue graft construct comprising submucosa of a warm-blooded vertebrate and a preselected group of eukaryotic cells are described. The improved tissue graft constructs can be used in accordance with the present invention to enhance the repair of damaged or diseased tissues in vivo.

Claims

1. An improved tissue graft construct comprising

a graft material comprising substantially acellular submucosal tissue of a warm-blooded vertebrate and

added cells selected from the group consisting of endothelial cells, keratinocytes, mesenchymal cells, chondrocytes, epithelial cells, osteoblasts, fibroblasts, smooth muscle cells, cardiac muscle cells, hepatocytes, skin cells, lung cells, cells of the ovary, and cells of the colon.

2. The graft composition of claim 1 wherein the cells are primary cells.

3. The graft composition of claim 1 wherein the cells have been genetically modified.

4. The graft composition of claim 1 wherein the cells are added and are thereafter cultured in vitro.

5. The graft composition of claim 1 wherein the cells are added to the luminal side of the submucosal tissue.

6. The graft composition of claim 1 wherein the cells are added to the abluminal side of the submucosal tissue.

7. The improved tissue graft of claim 1 wherein the graft material comprises tunica submucosa delaminated from both the tunica muscularis and at least the luminal portion of the tunica mucosa of vertebrate intestinal tissue.

8. The graft composition of claim 1 wherein the submucosal tissue is intestinal submucosal tissue and comprises basilar portions of the tunica mucosa including the lamina muscularis mucosa and the stratum compactum.

9. The graft composition of claim 1 wherein the submucosal tissue comprises collagens, glycoproteins, proteoglycans and glycosaminoglycans.

10. The graft composition of claim 1 wherein the submucosal tissue is fluidized.

11. The graft composition of claim 10 wherein the fluidized submucosal tissue comprises submucosa tissue digested with an enzyme for a period of time sufficient to solubilize the tissue.

12. The graft composition of claim 1 wherein the submucosal tissue is in sheet form.

13. The graft composition of claim 1 wherein the submucosal tissue is in gel form.

14. The graft composition of claim 1 wherein the submucosal tissue is in powder form.

15. The graft composition of claim 1 wherein the submucosal tissue is derived from intestinal tissue.

16. The graft composition of claim 1 wherein the submucosal tissue is derived from urinary bladder tissue.

17. The graft composition of claim 1 wherein the submucosal tissue is derived from stomach tissue.

18. The graft composition of claim 1 wherein the submucosal tissue is derived from uterine tissue.

19. The graft composition of claim 1 wherein the submucosal tissue is derived from tissue selected from the group consisting of porcine tissue, ovine tissue, and bovine tissue.

20. The graft composition of claim 19 wherein the submucosal tissue is derived from a pig.

21. The graft composition of claim 1 wherein the submucosal tissue is combined with nutrients or growth factors.

22. The graft composition of claim 21 wherein the nutrients are selected from the group consisting of minerals, amino acids, sugars, peptides, proteins, and glycoproteins.

23. The graft composition of claim 21 wherein the growth factors are selected from epidermal growth factor, platelet-derived growth factor, transforming growth factor beta, and fibroblast growth factor.

24. The graft composition of claim 1 wherein the submucosal tissue is sterilized with a peracid.

25. The graft composition of claim 24 wherein the peracid is peracetic acid.

26. The graft composition of claim 1 wherein the graft composition is wrapped in a plastic or a foil wrap.

27. The graft composition of claim 1 wherein the graft is a graft for repair of blood vessels.