Method for processing and preserving collagen-based tissues for transplantation

• US 5,336,616 A
• Filed: 02/02/1993
• Issued: 08/09/1994
• Est. Priority Date: 09/12/1990
• Status: Expired due to Term

• Current Assignee: Lifecell Corporation (Abbvie Incorporated)
• Original Assignee: Lifecell Corporation (Abbvie Incorporated)
• Inventors: Coleman, Christopher, Nichols, Ken B., Nag, Abhijit, Livesey, Stephen A., del Campo, Anthony A.
• Primary Examiner(s): Marx, Irene
• Assistant Examiner(s): DADIO, SUSAN
• Application Number:
  US08/004,752
• Time in Patent Office: 553 Days
• Field of Search: 435/1, 435/240.2, 435/240.3, 62/62, 623/15
• US Class Current: 435/395
• CPC Class Codes: A01N 1/00 Preservation of bodies of humans or animals, or parts thereof
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• CPC Class Codes: A61K 35/18 Erythrocytes haemoglobin A61K38/42
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/13 Poliovirus
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• 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 27/362 Skin, e.g. dermal papillae
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• 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 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3695 characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C12N 1/04 Preserving or maintaining viable microorganisms immobilised microorganisms C12N11/00
• CPC Class Codes: C12N 2770/32634 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: F25C 1/142 from the outer walls of cooled bodies
• CPC Class Codes: F26B 5/065 the product to be freeze-dried being sprayed, dispersed or pulverised

Abstract

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.

Claims

1. A method for processing collagen-based tissue for transplantation comprising:

(a) procuring said collagen-based tissue and placing said collagen-based tissue into a stabilizing solution to prevent osmotic, hypoxic, autolytic and proteolytic degradation and to protect against microbial contamination;

(b) incubating said collagen-based tissue in a processing solution to produce processed tissue, said processing solution extracting viable cells from the structural protein and collagen matrix of said collagen-based tissue;

(c) cryopreparing said processed tissue by incubation in a cryoprotective solution and freezing at cooling rates such that minimal functional damage occurs to the structural protein and collagen matrix of said processed tissue to produce cyoprepared, processed tissue;

(d) drying said cryoprepared, processed tissue under temperature and pressure conditions that permit removal of water without substantial ice recrystallization or ultrastructural damage, said drying resulting in a residual moisture content of said cyroprepared, processed tissue that permits both storage and rehydration of said tissue, to produce dried, cryoprepared, processed tissue;

(e) incubating said dried cyroprepared, processed tissue in a rehydration solution, said rehydration solution said rehydration solution preventing osmotic, hypoxic, autolytic, or proteolytic damage, microbial contamination and ultrastructural damage and to result in a rehydrated tissue having a final water content of 20% to 70%; and

(f) inoculation of said rehydrated tissue with viable cells selected from the group consisting of autogeneic cells, allogeneic cells or combinations thereof or allowing viable cells to repopulate said collagen matrix following transplantation.

2. The method of claim 1 wherein said rehydrated tissue comprises dermis.

3. The method of claim 1 wherein said rehydrated tissue comprises one or more vascular conduits of venous or arterial orgin.

4. The method of claim 1 wherein said rehydrated tissue comprises one or more heart valves.