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WO2023021525A1 - Matériau de pansement à base d'amnios-chorion humains et son procédé - Google Patents

Matériau de pansement à base d'amnios-chorion humains et son procédé Download PDF

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Publication number
WO2023021525A1
WO2023021525A1 PCT/IN2022/050734 IN2022050734W WO2023021525A1 WO 2023021525 A1 WO2023021525 A1 WO 2023021525A1 IN 2022050734 W IN2022050734 W IN 2022050734W WO 2023021525 A1 WO2023021525 A1 WO 2023021525A1
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WIPO (PCT)
Prior art keywords
membrane
placental
phmb
wound dressing
dressing material
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IN2022/050734
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English (en)
Inventor
Chirayu Padhiar
Mayur Abhaya
Muthuraman Muthuchamy
Vishnu Priya Mohan
Vignesh Ganesan
Ganesh Kumar Sarvesan
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Lifecell International Pvt Ltd
Original Assignee
Lifecell International Pvt Ltd
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Filing date
Publication date
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Publication of WO2023021525A1 publication Critical patent/WO2023021525A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0603—Embryonic cells ; Embryoid bodies
    • C12N5/0605—Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
    • A61L2300/206—Biguanides, e.g. chlorohexidine
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • a HUMAN AMNION-CHORION BASED WOUND DRESSING MATERIAL AND METHOD THEREOF FIELD OF THE INVENTION The present invention relates to the field of acute and chronic wound management and healing. More particularly, it relates to wound healing attributes of placental membrane allograft, dehydrated human amnion-chorion (dAmCh) membrane impregnated with the broad spectrum antimicrobial polymer, Polyhexamethylene Biguanide (PHMB). BACKGROUND OF THE INVENTION Placenta-derived membranes are widely used as cellular matrices in the treatment of chronic wounds (Hughes et al, 2016), being immunoprivileged they are ideal for allograft therapies.
  • dAmCh dehydrated human amnion-chorion
  • PHMB Polyhexamethylene Biguanide
  • HA amnion membrane
  • HACM composite amnion-chorion
  • PHMB Polyhexamethylene Biguanide
  • the cited references are different from the present inventions as (a) the developed product do not contain impregnated PHMB; (b) it is a multilayer, rigid construct which needs assembly of allograft, base sheet, and support layer into wound dressing; (c) it do not have an intact amnion-chorion membrane as they are separated by mechanical stripping; (d) the respective dressing is to be placed inside the boundaries of wound; and (e) it mentions about the application of processed viscous amniotic fluid to surgery site to enhance the healing.
  • D5: IN2456/CHE/2015A discloses a multi-step method for preparation of placental membrane scaffolds for treating wounds.
  • US20200337904 A1 is also very exhaustive and costly when compared to the present invention, as it involves many stages and different operations such as preparation of dehydrated human amnion or chorion membrane, collagen swelling, blending of oxidized regenerated cellulose (ORC), add plasticizer etc.
  • the material is highly processed and do not retain the original properties of intact amnion-chorion membrane.
  • the dressing material contains 2 different layers with added collage, ORC, and plasticizers. Also, please note that the synthesis method is completely different in US20200337904 A1 and the present invention.
  • D8 Polyhexamethylene Biguanide: Polyurethane Blend Nanofibrous Membranes forWound Infection Control, Polymers 2019, 11, 915; doi:10.3390/polym11050915, 22 May 2019, discloses the use of nano fibrous membranes prepared by blending PHMB and polyurethane to gradually release PHMB for wound infection control.
  • the synthesis procedure and working principle of the prior art is completely different from the present invention. This results in a product which is in nanoscale regime.
  • the prior art did not disclose any information regarding the use of human amnion-chorion membrane as in the present invention. Hence, kindly consider that our work is inventive in view of the prior art.
  • D1 to D4 discloses about development of rigid multilayer wound dressing constructs to be placed inside the boundaries of wounds.
  • D5 and D6 uses highly exhaustive steps to process the amnion and chorion membrane into multilayered material. Also, in the works D1 to D6 the amnion and chorion layers are separated and there was no mention of impregnation of PHMB which makes them entirely different from the present invention.
  • Reference D7 is a review paper that compares PHMB with other competitive materials.
  • Reference D8 is a physicochemical work which discloses the use of nano fibrous membranes. There is no mention about human amnion-chorion membrane in D7 and D8.
  • the present invention resulted in a new product (PHMB impregnated intact dAmCh), involves technical advance (impregnation of PHMB), have economic significance (minimal processing, minimal manipulation, easy to use, less medical intervention, bio absorbable and hence savings in disposal), and efficacy (synergetic effect of impregnated PHMB and dAmCh membrane in effective wound healing).
  • PHMB impregnated intact dAmCh involves technical advance (impregnation of PHMB), have economic significance (minimal processing, minimal manipulation, easy to use, less medical intervention, bio absorbable and hence savings in disposal), and efficacy (synergetic effect of impregnated PHMB and dAmCh membrane in effective wound healing).
  • the therapeutic possibilities in a combination of PHMB and placental membrane allografts has not been explored and is expected to have a cumulative effect in clearing infectious organisms from the wound.
  • a placental membrane based wound dressing material essentially consisting of: a polyhexamethylene biguanide impregnated dehydrated amnion-chorion membrane; wherein 0.5-2 % polyhexamethylene is distributed in 1 gm dehydrated amnion- chorion membrane. It is another aspect of the present invention to provide the placental membrane based wound dressing material, wherein 1gm of amnion-chorion membrane comprises of 5 mg of PHMB. It is another aspect of the present invention to provide the placental membrane based wound dressing material, wherein the dehydrated amnion-chorion is derived from human placental layers.
  • the antimicrobial agent is PHMB in combination with one or more of Tetracycline, Penicillin, Neomycin, Erythromycin, Clindamycin, Silver, Iodine, Chlorhexidine, Oflaxacin, Ethyl alcohol, Povidine iodine, Framycetin, Mupirocin, Dicloxacillin, Cephalosporins.
  • FIG. 1 Illustrates the flow chart of method of preparation of AmchoPlast – PHMB membrane.
  • Figure 2 illustrates the flow chart amnion-chorion membrane with 0.5% PHMB membrane – according to an embodiment of the present invention.
  • the present invention relates to the field of chronic wound management and healing. More particularly, AmchoPlast-PHMB: augmented antimicrobial activity and functional efficacy for the treatment of wounds.
  • the present invention gives a Minimally processed one-layer flexible membrane with intact amnion and chorion membrane having its regenerative properties.
  • the wound dressing material of the present invention can be placed over the wound or inside the wound also. Wound healing attributes of placental membrane allograft dehydrated human amnion-chorion (dAmCh) membrane is enhanced by impregnation with the broad-spectrum antimicrobial polymer Polyhexamethylene Biguanide (PHMB).
  • the components in the biomaterial have a synergic effect as evidenced by the augmented antimicrobial effect on planktonic culture of microbial species predominating the polyspecies-biofilms of infected recalcitrant wounds.
  • PHMB-AmchoPlast as an effective anti-biofilm agent would be established further using an in vitro biofilm model of chronic wound.
  • dAmCh retains the structural and biological properties of placental membrane.
  • the antimicrobial components and the array of cytokines, chemokines and growth factors facilitate repair and regeneration of infected wounds.
  • the method of preparation of wound dressing material involves:
  • the placental membrane collected in aseptic conditions and subjected to microbial and infectious disease screening is used for production of the dressing material.
  • the membrane with intact amnion and chorion layers is gently washed, dried and incubated for a standardized time in a defined concentration of PHMB solution.
  • PHMB concentration requirement in the wound dressing material is 0.5% w/w.
  • 0.125 gm of PHMB powder shall be dissolved in 100 ml of sterile water for injection.
  • the dehydrated membrane weight is 1 gm, it is required to add 4ml of 0.125% PHMB solution to achieve 0.5% of PHMB concentration in Final product (1 gm of tissue contains 5 mg of PHMB).
  • the dried membrane weight is noted, and soaking volume is calculated based on the weight (WEIGHT*4) of 1.25mg/ml PHMB for 4 hours in the shaker incubator at 100 (+/- 10) RPM. After 4 hours incubation the soaked membrane is removed from the container and spread on the Inverse “LC” Delrin block, where amnion is facing downward and chorion facing upward.
  • Chorionic layer is thicker compared to the amnion layer.
  • the amnion layer is comparatively translucent to the chorionic layer.
  • Delrin block placed in Tyvek pouch should be sealed and incubated in Hot air oven at 40 ⁇ 2 °C for 16-24 hours.
  • Packaging procedure for subjecting dehydrated membrane to Gamma radiation The dehydrated membrane is packed in Primary Pouch and sealed with nitrogen using a vacuum sealer. Then, primary packaged membrane is kept inside the Pre labelled Secondary pouch and sealed by purging with nitrogen. After dehydration the membrane is cut using laser with membrane sealed in Tyvek pouch to specific dimensions, sealed and sterilized by gamma irradiation 25kGy. The physical and functional characteristics of the product are validated by established protocols.
  • Antimicrobial property In vitro assays proving the synergic effect of PHMB and dAmCH.
  • the amniotic membrane is part of the inner layer of the placenta, this is a bilayer membrane composed of amnion and chorion.
  • the amniotic membrane if a daunting natural biological barrier that separates the fetal and maternal tissues. It is an immune-privileged tissue.
  • the use of dehydrated placental membranes in wound healing care has been successful in clinical trials. Nevertheless, bacterial infection of the wound remains as a major concern affecting the wound healing process.
  • coating of the dehydrated amnion chorion membrane with antimicrobial compounds could be an effective strategy to overcome this barrier.
  • the broad-spectrum antimicrobial Biocide Poly hexamethylene biguanide (PHMB) kills bacteria, fungi, parasites and certain viruses with a high therapeutic index.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Biotechnology (AREA)
  • Reproductive Health (AREA)
  • Public Health (AREA)
  • Cell Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Materials Engineering (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention se rapporte au domaine de la prise en charge de plaies aiguës et chroniques. L'invention se rapporte en particulier à un matériau de pansement pour plaie en membrane d'amnios et chorion déshydratée (dAmCh) humaine intacte imprégnée de polyhexaméthylène (PHMB) qui offre d'excellentes propriétés de cicatrisation des plaies.
PCT/IN2022/050734 2021-08-16 2022-08-16 Matériau de pansement à base d'amnios-chorion humains et son procédé Ceased WO2023021525A1 (fr)

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IN202141037032 2021-08-16
IN202141037032 2021-08-16

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WO2023021525A1 true WO2023021525A1 (fr) 2023-02-23

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024192119A1 (fr) * 2023-03-14 2024-09-19 Direct Biologics, Llc Compositions de cicatrisation et méthodes associées
US12213995B2 (en) 2019-07-18 2025-02-04 Direct Biologics, Llc Preparations comprising mesenchymal stem cells and cannabinoids and methods of their use
US12453743B2 (en) 2018-05-30 2025-10-28 Direct Biologics, Llc Mesenchymal stem cell (MSC) growth factor and extracellular vesicle preparation in frozen or powdered form and methods of use

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019126368A1 (fr) * 2017-12-20 2019-06-27 Kci Usa, Inc. Pansement comprenant un tissu placentaire déshydraté pour la cicatrisation des plaies
WO2019152110A1 (fr) * 2018-01-31 2019-08-08 Kci Usa, Inc. Composition antimicrobienne, pansement, composants de pansement et procédé
US20190282732A1 (en) * 2016-11-02 2019-09-19 Axogen Corporation Amnion tissue grafts and methods of preparing and using same

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190282732A1 (en) * 2016-11-02 2019-09-19 Axogen Corporation Amnion tissue grafts and methods of preparing and using same
WO2019126368A1 (fr) * 2017-12-20 2019-06-27 Kci Usa, Inc. Pansement comprenant un tissu placentaire déshydraté pour la cicatrisation des plaies
WO2019152110A1 (fr) * 2018-01-31 2019-08-08 Kci Usa, Inc. Composition antimicrobienne, pansement, composants de pansement et procédé

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TAN MARY, MORDIFFI SITI ZUBAIDAH, LANG DORA: "Effectiveness of polyhexamethylene biguanide impregnated dressing in wound healing : a systematic review protocol", JBI LIBRARY OF SYSTEMATIC REVIEWS, WOLTERS KLUWER - HEALTH LEARNING, RESEARCH & PRACTICE, US, vol. 14, no. 7, 1 July 2016 (2016-07-01), US , pages 76 - 83, XP093038655, ISSN: 2202-4433, DOI: 10.11124/JBISRIR-2016-002991 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12453743B2 (en) 2018-05-30 2025-10-28 Direct Biologics, Llc Mesenchymal stem cell (MSC) growth factor and extracellular vesicle preparation in frozen or powdered form and methods of use
US12213995B2 (en) 2019-07-18 2025-02-04 Direct Biologics, Llc Preparations comprising mesenchymal stem cells and cannabinoids and methods of their use
WO2024192119A1 (fr) * 2023-03-14 2024-09-19 Direct Biologics, Llc Compositions de cicatrisation et méthodes associées

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