Method for processing and preserving collagen-based tissues for transplantation
A method for processing and preserving an acellular collagen-based tissue matrix for transplantation is disclosed. The method includes the steps of processing biological tissues with a stabilizing solution to reduce procurement damage, treatment with a processing solution to remove cells, treatment with a cryoprotectant solution followed by freezing, drying, storage and rehydration under conditions that preclude functionally significant damage and reconstitution with viable cells.
1 . A method of making a tissue matrix, the method comprising:
(a) procuring a collagen-based tissue; and
(b) incubating the collagen-based tissue in a processing solution to produce processed tissue, wherein the processing solution extracts viable cells from the structural protein and collagen matrix of the collagen-based tissue,
wherein the processed tissue comprises a basement membrane to which viable endothelial cells or viable epithelial cells securely attach.
2 . The method of claim 1 , further comprising the steps of:
(c) cryopreparing the processed tissue by incubation in a cryoprotective solution; and
(d) freezing the processed tissue to produce a frozen, processed tissue,
wherein the frozen, processed tissue comprises a basement membrane to which, after thawing of the frozen, processed tissue, viable endothelial cells or viable epithelial cells securely attach.
3 . The method of claim 2 , further comprising the step of:
(e) drying the frozen, processed tissue to produce a dried, processed tissue,
wherein the dried, processed tissue comprises a basement membrane to which, after rehydration of the dried, processed tissue, viable endothelial cells or viable epithelial cells securely attach.
4 . The method of claim 3 , further comprising the step of:
(f) incubating the dried, processed tissue in a rehydration solution to give a rehydrated tissue,
wherein the rehydrated tissue comprises a basement membrane to which viable endothelial cells or viable epithelial cells securely attach.
5 . The method of claim 4 , further comprising the step of:
(g) inoculating the rehydrated tissue with autogeneic cells, allogeneic cells, or a combination of autogeneic cells and allogeneic cells,
wherein the rehydrated tissue, after the inoculation, comprises a basement membrane to which viable endothelial cells or viable epithelial cells securely attach.
6 . The method of claim 1 , wherein the collagen-based tissue comprises dermis.
7 . The method of claim 1 , wherein the collagen-based tissue comprises a tissue of venous or arterial origin.
8 . The method of claim 7 , wherein the tissue of venous origin is saphenous vein tissue.
9 . The method of claim 1 , wherein the collagen-based tissue comprises a heart valve.
10 . The method of claim 1 , wherein the collagen-based tissue comprises heart valve leaflet tissue.
11 . The method of claim 1 , wherein the collagen-based tissue is a human collagen-based tissue.
12 . The method of claim 1 , wherein the collagen-based tissue is a non-human animal collagen-based tissue.
13 . The method of claim 12 , wherein the non-human animal is a pig.
14 . The method of claim 12 , wherein the non-human animal is a dog.
15 . The method of claim 1 , wherein the collagen-based tissue comprises a tissue selected from the group consisting of ligament tissue, tendon tissue, bone tissue, cartilage tissue, dura mater tissue, and nerve tissue.
16 . A tissue matrix made by the method of claim 1 .
17 . A method of treatment comprising grafting the tissue matrix of claim 16 to or into a patient.
18 . The method of claim 17 , wherein the patient is selected from the group consisting of a burn patient, a diabetic patient, a patient with pressure ulcers, a patient requiring reconstructive surgery, and a patient requiring skin replacement following excision of a skin lesion.