WO2001008716A1 - Procede de conservation des amnions, et ses utilisations - Google Patents

Procede de conservation des amnions, et ses utilisations Download PDF

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Publication number
WO2001008716A1
WO2001008716A1 PCT/AU2000/000913 AU0000913W WO0108716A1 WO 2001008716 A1 WO2001008716 A1 WO 2001008716A1 AU 0000913 W AU0000913 W AU 0000913W WO 0108716 A1 WO0108716 A1 WO 0108716A1
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WIPO (PCT)
Prior art keywords
amnion
wound
packaged
wound dressing
mammal
Prior art date
Application number
PCT/AU2000/000913
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English (en)
Inventor
Ann Pinfold
Original Assignee
Ann Pinfold
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 Ann Pinfold filed Critical Ann Pinfold
Priority to AU61402/00A priority Critical patent/AU6140200A/en
Publication of WO2001008716A1 publication Critical patent/WO2001008716A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0205—Chemical aspects
    • A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
    • A01N1/0215—Disinfecting agents, e.g. antimicrobials for preserving living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • 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
    • A61K35/48—Reproductive organs
    • A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
    • 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
    • A61L27/60—Materials for use in artificial skin

Definitions

  • This invention relates to a method of preservation and in particular to a method of preservation of amnion. uses of amnion and methods of treatment using amnion.
  • Amnion including human amnion, has been used sporadically since the beginning of this century to aid in the wound-healing process.
  • the benefits of amnion as a wound dressing have been well-documented since the late 1970's.
  • Amnion is the membrane that completely lines the uterine cavity, in which the foetus develops and grows. It is initially composed of a single layer of cells, formed when the ovum is fertilised and the cells begin to divide. The developing foetus is enclosed within the amnion and is spared from destruction by the maternal immune system. While not completely understood, the unique feature which makes amnion an impermeable immunological barrier between mother and embryo is its lack of expression of surface antigens which normally mediate an immune response, for example major histocompatibility complex antigens (MHC). Taken a step further, amnion may be used as skin grafts without the need to tissue type donors to hosts.
  • MHC major histocompatibility complex antigens
  • Amnion dressings harvested from one species have proven beneficial in treating injuries in other species.
  • fresh amnion dressings harvested from equine species while extremely beneficial in treating equine injuries, have also proven to be beneficial in treating injuries in avian species.
  • Previous literature indicates that amnion dressings offer pain relief, inhibit bacterial activity, control exuberant granulation tissue, speed wound closure and reduce scarring.
  • Lyophilisation vacuum freeze-drying
  • lyophilisation is a method by which amnion may be preserved which provides an extended shelf-life of more than 2 years if stored under the correct conditions.
  • Lyophilisation is a well-known dehydration technique and includes vaporisation of the frozen moisture content of tissue under conditions of vacuum. Because dehydration is carried out at very low temperatures, the method has the potential to preserve temperature-sensitive molecules such as the biological proteins and enzymes found within amniotic tissue.
  • the invention provides a method of preserving amnion, or part thereof, such that one or more of the biological properties of the amnion are substantially retained, including the step of lyophilising the amnion, or part thereof.
  • the biological property retained is a wound-healing property although the retention of one or more of the other biological properties of amnion, such as pain relief, anti-inflammatory activity, swelling reduction, inhibition of bacterial activity, control of exuberant granulation, wound-healing and scar reduction is also contemplated.
  • the other biological properties of amnion such as pain relief, anti-inflammatory activity, swelling reduction, inhibition of bacterial activity, control of exuberant granulation, wound-healing and scar reduction is also contemplated.
  • the biological property is a wound-healing property.
  • the amnion, or part thereof is derived from an equine source although one skilled in the art will recognise that it may be from any other mammalian source eg. bovine or alpaca sources.
  • the amnion, or part thereof is placed in approximately 2% povidon iodine/saline solution within approximately 24 hours after birth of an offspring.
  • the amnion, or part thereof is cut into sections suitable for use as dressings. Most preferably the sections are approximately 5 cms by approximately 10 cms.
  • the invention provides a method of preserving an amnion, or part thereof including the steps of a) treating the amnion, or part thereof, with a sterilising solution; b) rinsing the amnion, or part thereof, in sterile saline and acetic acid; and c) lyophilising the amnion, or part thereof.
  • the invention provides a method of preparing a wound dressing including the steps of a) treating amnion, or part thereof, in a sterilising solution; b) rinsing the amnion, or part thereof, in sterile saline and acetic acid; c) lyophilising the amnion, or part thereof; and d) rehydrating the lyophilised amnion, or part thereof, as required.
  • the sterilising solution is a povidon iodine/saline solution.
  • the sterilising solution is a solution of approximately 2% povidon iodine in saline.
  • the sterile saline and acetic acid solution of step (b) contains approximately 0.25% v/v acetic acid.
  • rehydration is carried out in saline solution.
  • the invention provides amnion, or part thereof, prepared by the method of the first or second aspects.
  • the invention provides a wound dressing prepared by the method of the third aspect.
  • the invention provides a method of treating a wound in an animal including the application of the amnion of the fourth aspect and/or the wound dressing of the fifth aspect to the site of the wound.
  • the amnion, or part thereof is rehydrated. Preferably it is rehydrated by exposure to saline solution. Preferably the amnion, or part thereof, and/or wound dressing is applied to the wound under paraffin impregnated gauze dressings.
  • the animal is a mammal and most preferably it is an equine species.
  • the method is also useful for the treatment of humans and any other animals to which such amnion, or part thereof, could conceivably be applied.
  • the invention provides use of the amnion, or part thereof, of the fourth aspect and/or the wound dressing of the fifth aspect for the manufacture of a medicament for the treatment of a wound in an animal.
  • the invention provides lyophilised amnion.
  • the invention provides packaged amnion, or part thereof, wherein the amnion, or part thereof, is preserved according to the first or second aspects and further packaged.
  • the invention provides a packaged wound dressing, wherein the dressing is prepared according to the third aspect and further packaged.
  • the packaged amnion, or part thereof, or wound dressing is packaged in heat-sealed, laminated pouches.
  • the pouches prevent moisture penetration and contamination of the packaged amnion, or part thereof, or the packaged wound dressing.
  • the invention provides a method of treating pain, inflammation and/or swelling in an animal including the application of (a) amnion, or part thereof, and/or (b) a wound dressing according to the invention, to the site of the pain, inflammation and/or swelling.
  • the amnion, or part thereof is rehydrated. More preferably, the amnion, or part thereof is rehydrated by exposure to saline solution.
  • the animal is a mammal. More preferably, the mammal is an equine species.
  • the mammal may also be a human and that the method may be applied to any other animals to which such amnion, or part thereof, and/or the wound dressing, could conceivably be applied.
  • the invention provides use of (a) amnion, or part thereof, and/or (b) a wound dressing according to the invention for the manufacture of a medicament for the treatment of pain, inflammation and/or swelling in an animal.
  • the animal is a mammal. More preferably, the mammal is an equine species.
  • the mammal may also be a human and that the method may be applied to any other animals to which such amnion, or part thereof, and/or the wound dressing, could conceivably be applied.
  • biological property refers to the property of pain relief, anti-inflammatory activity, swelling reduction, inhibition of bacterial activity, control of exuberant granulation, wound-healing, scar reduction and the like.
  • Example 1 The following examples make use of equine amnion as a convenient way of exemplifying the invention because equine amnion is easily recoverable and each foaling produces amnion in abundance.
  • the average equine amnion comprises a substantial amount of tissue, averaging 50-100 dressings of 5 x 10 cms.
  • a draught horse amnion produced 190 dressings of varying sizes.
  • equine amnion was used as an example are that the number of equine births per year is large, often concentrated in large numbers in particular regions.
  • the equine foaling season is generally concentrated between August and January, with most bloodstock born during August and September.
  • the bigger studs, particularly those involved in the bloodstock industry usually have many foals born on their properties each season. Due to the value of racing stock and the limitations imposed by the production of just one offspring per year, each foaling is normally monitored.
  • the membranes of afterbirth, including the amnion and placenta are usually collected and inspected to ensure they are "complete" in order to avoid post partum uterine infection in the mare.
  • Fresh amnion is cleaned, washed with copious amounts of tap water and badly torn or grossly contaminated areas are excised.
  • Amnion is placed in a plastic container, covered with 2% povidon iodine/saline solution and refrigerated for 24-48 hours. The amnion is cut to suitable size for freeze-drying trays. The amnion is sequentially rinsed in 3 sterile baths of saline alone and rinsed in a final bath of saline containing 0.25% v/v acetic acid. The amnion is then layered between aluminium foil and frozen in flat sheets.
  • amnion is placed in a chamber, one layer per shelf, and vacuum freeze-dried, over a period of 20-24 hours.
  • the freeze-dried (lyophilised) amnion is removed from the chamber, cut into individual dressings and packaged.
  • Each equine foaling produces viable quantities of amnion, averaging 50-100 dressings of 5 x 10 cms in vapour barrier packs.
  • These packs consist of heat-sealed laminated pouches, constructed to keep the dressings dry and sterile. Failure rate of this type of packaging should be minimal, and is generally due to rough handling causing pinholes or splitting. Storage life is enhanced by reduced handling and storing in cool, dry areas out of direct sunlight. Reconstitution
  • Test 1 involved a gelding with an extensive injury to the anterior and lateral aspects of the hock. The wound was grossly contaminated and debri dement of skin flaps was necessary. Conventional treatment over a two-week period resulted in no improvement and granulation tissue had elevated above the skin edges. Copious exudate necessitated bandage changes every day.
  • Lyophilised amnion dressings were reconstituted and were applied under Vaseline- coated cotton pad dressings, with dressing changes twice per week in the initial stages. After two weeks the dressings and bandages were reapplied once per week. Within the first two weeks the inflammation settled and the granulation tissue reduced to level within the skin edges. No signs of bacterial infection were present and exudate was markedly reduced. Due to the extent of the injury and its location, the wound was treated with amnion dressings for 7 weeks. The amount of disfigurement and scarring was much less than anticipated for this type of injury. This successful outcome led to the search for an improved method of storing amnion.
  • Test 2 involved a 26 year old mare with a 4 cm long cut midway along the anterior aspect of a hind cannon. The cut penetrated full-thickness and, due to swelling, the skin edges were not in apposition. The wound did not appear contaminated. It was bathed with an antiseptic solution containing 10%> w/v povidone-iodine (Betadine®) and a reconstituted lyophilised amnion dressing prepared according to the method indicated in Example 1 was applied. This was covered with paraffin impregnated gauze dressing (Jelonet ) and bandaged with a flexible bandaging tape (Vetwrap ) and an elastic, adhesive tape (Conform®). The bandage was removed on day 4 and all swelling was gone.
  • Triaffin impregnated gauze dressing Jelonet
  • Vetwrap flexible bandaging tape
  • Conform® elastic, adhesive tape
  • Example 4 Further experiments using reconstituted lyophilised amnion as wound dressings were performed on a variety of distal limb injuries in 12 horses. These included knee, cannon, fetlock, pastern and foot wounds. Wounds were treated on an approximately weekly basis with lyophilised amnion which was reconstituted and applied under paraffin-impregnated gauze dressings.
  • Reconstituted lyophilised amnion reduced the amount of fresh wound "breakdown" which usually occurs 3-5 days after injury.
  • Wound "breakdown” includes tissue sloughing accompanied by excessive exudate production. For example, typically during the first 3-5 days of a sutured equine distal limb injury, the wound appears to be closing well. Shortly thereafter, the wound appears to regress; it develops a discharge, bad odour and loss of epithelial tissue, particularly around wound edges. Often sutures tear through or fall out due to sloughing of wound edges, and underlying tissues are revealed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Wood Science & Technology (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Environmental Sciences (AREA)
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  • Developmental Biology & Embryology (AREA)
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  • Dermatology (AREA)
  • Pharmacology & Pharmacy (AREA)
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Abstract

L'invention porte sur un procédé de conservation des amnions permettant de conserver quasiment une ou plusieurs de leurs propriétés biologiques telles que l'analgésie, les activités anti-inflammatoires, la réduction de l'enflure, l'inhibition de l'activité bactérienne, le contrôle de l'activité exubérante, la cicatrisation, ou la réduction des cicatrices. L'invention porte sur un procédé de préparation de pansements à base d'amnions, sur l'utilisation d'amnions pour la fabrication de médicaments, sur des amnions encapsulés, et sur des procédés de traitement de blessures, de douleurs d'inflammations et/ou d'enflure chez l'animal à l'aide d'amnions.
PCT/AU2000/000913 1999-08-02 2000-08-02 Procede de conservation des amnions, et ses utilisations WO2001008716A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU61402/00A AU6140200A (en) 1999-08-02 2000-08-02 Method of preservation of amnion and uses thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPQ1967 1999-08-02
AUPQ1967A AUPQ196799A0 (en) 1999-08-02 1999-08-02 Method of preservation of amnion and uses thereof

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WO2001008716A1 true WO2001008716A1 (fr) 2001-02-08

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Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005021014A1 (fr) * 2003-09-03 2005-03-10 Jiuchang Miao Preparation d'un amnios biologique conservable a temperature ambiante
JPWO2004078225A1 (ja) * 2003-02-26 2006-06-08 アルブラスト株式会社 羊膜由来医用材料、及びその作製方法
US8231908B2 (en) * 2005-07-25 2012-07-31 Arblast Co., Ltd. Sheet-like composition
WO2014028657A1 (fr) * 2012-08-15 2014-02-20 Mimedx Group, Inc Greffes de tissu placentaire renforcées et procédés de fabrication et d'utilisation de celles-ci
US8904664B2 (en) 2012-08-15 2014-12-09 Mimedx Group, Inc. Dehydration device and methods for drying biological materials
CN104998294A (zh) * 2015-08-03 2015-10-28 罗静峰 一种杀菌止血的医用敷料的制备方法
US9180145B2 (en) 2012-10-12 2015-11-10 Mimedx Group, Inc. Compositions and methods for recruiting and localizing stem cells
US9463206B2 (en) 2011-12-22 2016-10-11 Mimedx Group, Inc. Cross-linked dehydrated placental tissue grafts and methods for making and using the same
US9655948B1 (en) 2013-01-17 2017-05-23 Mimedx Group, Inc. Non-surgical, localized delivery of compositions for placental growth factors
US9827293B2 (en) 2013-01-17 2017-11-28 Mimedx Group, Inc. Non-surgical, localized delivery of compositions for placental growth factors
US9943551B2 (en) 2012-08-15 2018-04-17 Mimedx Group, Inc. Tissue grafts composed of micronized placental tissue and methods of making and using the same
US10029030B2 (en) 2013-03-15 2018-07-24 Mimedx Group, Inc. Molded placental tissue compositions and methods of making and using the same
US10052351B2 (en) 2014-01-17 2018-08-21 Mimedx Group, Inc. Method for inducing angiogenesis
US10105398B2 (en) 2011-02-14 2018-10-23 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US10111910B2 (en) 2013-01-18 2018-10-30 Mimedx Group, Inc. Methods for treating cardiac conditions
US10159744B2 (en) 2012-11-19 2018-12-25 Mimedx Group, Inc. Cross-linked collagen comprising metallic anticancer agents
US10206977B1 (en) 2013-01-18 2019-02-19 Mimedx Group, Inc. Isolated placental stem cell recruiting factors
US10232085B2 (en) 2011-02-14 2019-03-19 Mimedx Group, Inc. Tissue grafts modified with a cross-linking agent and method of making and using the same
US10517931B2 (en) 2013-01-17 2019-12-31 Mimedx Group, Inc. Non-surgical, localized delivery of compositions for placental growth factors
US10617785B2 (en) 2014-08-28 2020-04-14 Mimedx Group, Inc. Collagen reinforced tissue grafts
US11338063B2 (en) 2012-08-15 2022-05-24 Mimedx Group, Inc. Placental tissue grafts modified with a cross-linking agent and methods of making and using the same

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Cited By (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2004078225A1 (ja) * 2003-02-26 2006-06-08 アルブラスト株式会社 羊膜由来医用材料、及びその作製方法
WO2005021014A1 (fr) * 2003-09-03 2005-03-10 Jiuchang Miao Preparation d'un amnios biologique conservable a temperature ambiante
US8231908B2 (en) * 2005-07-25 2012-07-31 Arblast Co., Ltd. Sheet-like composition
US11103536B2 (en) 2011-02-14 2021-08-31 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US10105397B2 (en) 2011-02-14 2018-10-23 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US11931384B2 (en) 2011-02-14 2024-03-19 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US10376546B2 (en) 2011-02-14 2019-08-13 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US11235007B2 (en) 2011-02-14 2022-02-01 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US11219647B2 (en) 2011-02-14 2022-01-11 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US10869952B2 (en) 2011-02-14 2020-12-22 Mimedx Group, Inc. Tissue grafts modified with a cross-linking agent and method of making and using the same
US10869951B2 (en) 2011-02-14 2020-12-22 Mimedx Group, Inc. Tissue grafts modified with a cross-linking agent and method of making and using the same
US10232085B2 (en) 2011-02-14 2019-03-19 Mimedx Group, Inc. Tissue grafts modified with a cross-linking agent and method of making and using the same
US10105398B2 (en) 2011-02-14 2018-10-23 Mimedx Group, Inc. Micronized placental tissue compositions and methods of making and using the same
US9463206B2 (en) 2011-12-22 2016-10-11 Mimedx Group, Inc. Cross-linked dehydrated placental tissue grafts and methods for making and using the same
US9943551B2 (en) 2012-08-15 2018-04-17 Mimedx Group, Inc. Tissue grafts composed of micronized placental tissue and methods of making and using the same
US11338063B2 (en) 2012-08-15 2022-05-24 Mimedx Group, Inc. Placental tissue grafts modified with a cross-linking agent and methods of making and using the same
US11607430B2 (en) 2012-08-15 2023-03-21 Mimedx Group, Inc. Tissue grafts composed of micronized placental tissue and methods of making and using the same
WO2014028657A1 (fr) * 2012-08-15 2014-02-20 Mimedx Group, Inc Greffes de tissu placentaire renforcées et procédés de fabrication et d'utilisation de celles-ci
US10857266B2 (en) 2012-08-15 2020-12-08 Mimedx Group, Inc. Reinforced placental tissue grafts and methods of making and using the same
US8904664B2 (en) 2012-08-15 2014-12-09 Mimedx Group, Inc. Dehydration device and methods for drying biological materials
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