WO2017127228A1 - Xénogreffes de tissus conjonctifs denses réguliers - Google Patents

Xénogreffes de tissus conjonctifs denses réguliers Download PDF

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Publication number
WO2017127228A1
WO2017127228A1 PCT/US2017/000006 US2017000006W WO2017127228A1 WO 2017127228 A1 WO2017127228 A1 WO 2017127228A1 US 2017000006 W US2017000006 W US 2017000006W WO 2017127228 A1 WO2017127228 A1 WO 2017127228A1
Authority
WO
WIPO (PCT)
Prior art keywords
xenograft
human
connective tissue
dense regular
implantation
Prior art date
Application number
PCT/US2017/000006
Other languages
English (en)
Inventor
Kevin R. Stone
Uri Galili
Thomas Turek
Original Assignee
Aperion Biologics Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aperion Biologics Inc. filed Critical Aperion Biologics Inc.
Publication of WO2017127228A1 publication Critical patent/WO2017127228A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/34—Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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
    • A61L27/3625—Vascular tissue, e.g. heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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
    • A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/40—Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking

Definitions

  • the cellular disruption treatment of the present invention preferably involves the use of surfactants to decellularize the tissue and remove the cells from the tissue.
  • the tissue is immersed in solution comprising a mixture of nonionic surfactant, anionic surfactant and peroxide.
  • the tissue is rinsed and placed in a second solution comprising sodium deoxycholate in distilled water.
  • the cellular disruption treatment may be performed by
  • ligament tissue and heart valve tissue are harvested from a pig to form a tendon xenograft, a ligament xenograft and a heart valve xenograft, respectively, using procedures known to one of ordinary skill in the art, forming base xenografts.
  • the respective harvested tissues i.e., the base xenografts, all include an array of substantially parallel, mutually adjacent collagen fibers, a defining characteristic of dense regular connective tissue.
  • the respective harvested tissues are characterized by a base porosity.
  • the harvested tissue is washed using standard techniques known in the art.
  • the xenograft can be sterilized in addition to the
  • Sterilization can be accomplished by electron beam radiation, ultra violet radiation, and gamma radiation, either alone or in any combination, and with other possible methods.
  • e-bcam radiation is used to sterilize the tissue
  • the xenograft is exposed to e-beam radiation in a dose range of 15-20 kGy.

Abstract

L'invention concerne des procédés de préparation et d'utilisation de xénogreffes de tissus conjonctifs denses réguliers à partir d'animaux non humains pour réparer et/ou remplacer un tissu humain endommagé correspondant. Des xénogreffes de tissus conjonctifs denses réguliers d'origine non humaine, qui se présentent par exemple sous la forme de xénogreffes de tendons, de ligaments ou de valvules cardiaques, lorsqu'elles sont implantées chez un sujet humain, constituent un échafaudage pour la réparation et la régénération d'un tissu natif, ou éventuellement pour des applications orthopédiques de tissus conjonctifs denses. La xénogreffe est soumise à au moins un traitement de décellularisation ou de dissociation cellulaire, et est désantigénée avec une alpha-galactosidase. La décellularisation consiste à effectuer une immersion dans un tensioactif anionique, un tensioactif non ionique et un peroxyde. Après décellularisation et désantigénation, le tissu de xénogreffe est sensiblement exempt d'épitopes d'alpha-galactosyle.
PCT/US2017/000006 2016-01-22 2017-01-20 Xénogreffes de tissus conjonctifs denses réguliers WO2017127228A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662388274P 2016-01-22 2016-01-22
US62/388,274 2016-01-22

Publications (1)

Publication Number Publication Date
WO2017127228A1 true WO2017127228A1 (fr) 2017-07-27

Family

ID=59361987

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/000006 WO2017127228A1 (fr) 2016-01-22 2017-01-20 Xénogreffes de tissus conjonctifs denses réguliers

Country Status (1)

Country Link
WO (1) WO2017127228A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110038168A (zh) * 2019-04-26 2019-07-23 中国医科大学 一种由脱细胞基质制备的肌腱防粘连膜及其制备方法
CN110507855A (zh) * 2019-09-05 2019-11-29 南京屹特博医学科技发展有限公司 一种用于局部支撑作用的异种肋软骨制备方法
EP4052734A1 (fr) * 2021-03-02 2022-09-07 Jeevan Nagendran Échafaudage de tissus immunocompatible et ses procédés de formation

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080077251A1 (en) * 1999-06-07 2008-03-27 Chen Silvia S Cleaning and devitalization of cartilage
US20110244054A1 (en) * 2009-10-07 2011-10-06 Gudmundur Fertram Sigurjonsson Scaffold material for wound care and/or other tissue healing applications
US20140154663A1 (en) * 2000-09-12 2014-06-05 Lifenet Health Process for Devitalizing Soft-Tissue Engineered Medical Implants, and Devitalized Soft-Tissue Medical Implants Produced
US20150182664A1 (en) * 2002-08-21 2015-07-02 Revivicor, Inc. Tissue Products Derived from Animals Lacking any Expression of Functional Alpha 1, 3 Galactosyltransferase
US9150318B1 (en) * 2009-01-02 2015-10-06 Lifecell Corporation Method for sterilizing an acellular tissue matrix

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080077251A1 (en) * 1999-06-07 2008-03-27 Chen Silvia S Cleaning and devitalization of cartilage
US20140154663A1 (en) * 2000-09-12 2014-06-05 Lifenet Health Process for Devitalizing Soft-Tissue Engineered Medical Implants, and Devitalized Soft-Tissue Medical Implants Produced
US20150182664A1 (en) * 2002-08-21 2015-07-02 Revivicor, Inc. Tissue Products Derived from Animals Lacking any Expression of Functional Alpha 1, 3 Galactosyltransferase
US9150318B1 (en) * 2009-01-02 2015-10-06 Lifecell Corporation Method for sterilizing an acellular tissue matrix
US20110244054A1 (en) * 2009-10-07 2011-10-06 Gudmundur Fertram Sigurjonsson Scaffold material for wound care and/or other tissue healing applications

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110038168A (zh) * 2019-04-26 2019-07-23 中国医科大学 一种由脱细胞基质制备的肌腱防粘连膜及其制备方法
CN110507855A (zh) * 2019-09-05 2019-11-29 南京屹特博医学科技发展有限公司 一种用于局部支撑作用的异种肋软骨制备方法
CN110507855B (zh) * 2019-09-05 2022-04-19 南京屹特博医学科技发展有限公司 一种用于局部支撑作用的异种肋软骨制备方法
EP4052734A1 (fr) * 2021-03-02 2022-09-07 Jeevan Nagendran Échafaudage de tissus immunocompatible et ses procédés de formation

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