JP7460048B2 - 動物の骨からの異種移植片の製造 - Google Patents
動物の骨からの異種移植片の製造 Download PDFInfo
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- JP7460048B2 JP7460048B2 JP2022576530A JP2022576530A JP7460048B2 JP 7460048 B2 JP7460048 B2 JP 7460048B2 JP 2022576530 A JP2022576530 A JP 2022576530A JP 2022576530 A JP2022576530 A JP 2022576530A JP 7460048 B2 JP7460048 B2 JP 7460048B2
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- 210000000988 bone and bone Anatomy 0.000 title claims description 97
- 238000004519 manufacturing process Methods 0.000 title claims description 7
- 238000000034 method Methods 0.000 claims description 42
- 239000012634 fragment Substances 0.000 claims description 29
- 239000002904 solvent Substances 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 18
- 239000008213 purified water Substances 0.000 claims description 15
- 238000011282 treatment Methods 0.000 claims description 15
- 238000005406 washing Methods 0.000 claims description 13
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 8
- 239000012074 organic phase Substances 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 7
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 5
- 210000001519 tissue Anatomy 0.000 claims description 5
- 239000005708 Sodium hypochlorite Substances 0.000 claims description 4
- 238000009835 boiling Methods 0.000 claims description 4
- SUKJFIGYRHOWBL-UHFFFAOYSA-N sodium hypochlorite Chemical compound [Na+].Cl[O-] SUKJFIGYRHOWBL-UHFFFAOYSA-N 0.000 claims description 4
- 229910001867 inorganic solvent Inorganic materials 0.000 claims description 3
- 239000003049 inorganic solvent Substances 0.000 claims description 3
- 239000003960 organic solvent Substances 0.000 claims description 3
- 238000000926 separation method Methods 0.000 claims description 3
- 239000000463 material Substances 0.000 description 13
- 238000010438 heat treatment Methods 0.000 description 11
- 239000000126 substance Substances 0.000 description 9
- 238000012545 processing Methods 0.000 description 8
- 238000001311 chemical methods and process Methods 0.000 description 7
- 238000006065 biodegradation reaction Methods 0.000 description 6
- 239000001506 calcium phosphate Substances 0.000 description 6
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 6
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 6
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 6
- 239000011575 calcium Substances 0.000 description 4
- 230000008878 coupling Effects 0.000 description 4
- 238000010168 coupling process Methods 0.000 description 4
- 238000005859 coupling reaction Methods 0.000 description 4
- 239000013078 crystal Substances 0.000 description 4
- 239000003925 fat Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 4
- 235000019731 tricalcium phosphate Nutrition 0.000 description 4
- 229940078499 tricalcium phosphate Drugs 0.000 description 4
- 238000000354 decomposition reaction Methods 0.000 description 3
- 230000011164 ossification Effects 0.000 description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 description 3
- 102000004169 proteins and genes Human genes 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 238000001354 calcination Methods 0.000 description 2
- 229910000389 calcium phosphate Inorganic materials 0.000 description 2
- 235000011010 calcium phosphates Nutrition 0.000 description 2
- 210000000845 cartilage Anatomy 0.000 description 2
- 230000001054 cortical effect Effects 0.000 description 2
- 239000004053 dental implant Substances 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000012266 salt solution Substances 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000027205 Congenital disease Diseases 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 239000003462 bioceramic Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000010478 bone regeneration Effects 0.000 description 1
- 230000010072 bone remodeling Effects 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 125000005587 carbonate group Chemical group 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000005906 dihydroxylation reaction Methods 0.000 description 1
- 210000004195 gingiva Anatomy 0.000 description 1
- 238000001027 hydrothermal synthesis Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011368 organic material Substances 0.000 description 1
- 239000005416 organic matter Substances 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- 239000012071 phase Substances 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 239000012254 powdered material Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000004729 solvothermal method Methods 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
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- 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
- A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
-
- 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
- A61L27/3641—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 site of application in the body
- A61L27/3645—Connective tissue
- A61L27/365—Bones
-
- 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
- A61L27/36—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
- A61L27/3691—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 physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
-
- 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
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
-
- 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
- A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
-
- 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
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Botany (AREA)
- General Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Zoology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Meat, Egg Or Seafood Products (AREA)
Description
i)1atmを超える圧力及び100℃~300℃の範囲の温度で、溶媒で海綿骨の水熱及び/又はソルボサーマル処理を行う工程ステップを含む。
a)海綿組織を有する動物の骨(例えば、大腿骨の頭部-大腿骨頭)を粉砕することによる海綿骨断片の取得。それに応じて、骨の海綿質部分を軟骨及び皮質骨から分離することができるので、海綿骨断片を、好ましくは0.5~1.5センチメートル程度で得ることができる。
b)海綿骨断片中の有機相の部分的除去(例えば、脂肪、血液、及びその他の望ましくない有機相の部分的除去/分離)。それに応じて、例えば、海綿骨断片は精製水で1~2時間の間に10~15回洗浄してもよく、精製水で30~60分間の間に3~5回煮沸してもよい。
c)海綿骨の有機相のさらなる除去/分離。それに応じて、海綿骨は、有機成分(例えば、タンパク質、脂肪、DNA、細胞など)を溶解することができる溶媒と接触させることができ、このステップは、「化学処理ステップ」及び「脱細胞」と呼ばれることがある。このステップでは、海綿骨を、次亜塩素酸ナトリウム、クロロホルム、アセトン、若しくはそれらの混合物などの、有機相(脂肪、タンパク質など)を溶解し、海綿骨から有機相を除去する溶媒、さらに、又は他の有機、無機、及びイオン溶液(塩溶液など)若しくはそれらの混合物とも、例えば、7~15日間の期間接触させ、好ましくは継続的に撹拌する。
d)海綿骨断片の洗浄。洗浄ステップによって、海綿骨断片は、ステップ(c)で述べた溶媒及び他の可能な残留物から取り出される。前記洗浄工程は、例えば精製水で1~2時間の間に10~15回繰り返してもよい。
e)海綿骨断片の洗浄。こうして、海綿骨断片にまだ存在している可能性のあるいかなる残留物も除去される。前記洗浄工程は、例えば、水、例えば、精製水で実施することができる。洗浄工程は、例えば、1日~7日の期間で、例えば3回以上繰り返してもよい。
f)乾燥による海綿骨断片の脱水。前記乾燥工程は、例えば、50℃~100℃の範囲の温度で、例えば、1~2日の範囲の期間で実施することができる。
20 フィルターパッド
30 保持器
40 カップリングカバー
50 カバー
60 ライナー
70 外殻
80 溶媒
90 基部
Claims (10)
- a)海綿組織を有する動物の骨を粉砕することによる0.5~1.5センチメートルの大きさの海綿骨断片の取得、
b)前記海綿骨断片中の有機相の部分的除去、
c)前記海綿骨の前記有機相のさらなる除去/分離、
d)前記海綿骨断片の洗浄、
i)1atmを超える圧力及び100℃~300℃の範囲の温度での、溶媒で前記海綿骨断片の水熱及び/又はソルボサーマル処理、
e)前記海綿骨断片の洗浄、及び
f)前記海綿骨断片の乾燥、
を含むことを特徴とする、異種骨移植片を製造するための方法。 - 前記溶媒が、有機溶剤、無機溶媒、イオン溶液、及びそれらの混合物から選択される、請求項1に記載の方法。
- 前記溶媒が、精製水、次亜塩素酸ナトリウム、クロロホルム、アセトン、又はそれらの混合物から選択される、請求項2に記載の方法。
- 前記水熱及び/又はソルボサーマル処理ステップが6時間~24時間の期間継続される、請求項1~3のいずれか一項に記載の方法。
- ステップ(b)において、前記海綿骨断片を精製水で1時間~2時間の期間に10~15回の範囲の反復数で洗浄し、精製水で30分~60分の期間に3~5回の範囲の反復数で煮沸する、請求項1~4のいずれか一項に記載の方法。
- ステップ(c)において、前記海綿骨を、有機成分を溶解することができる溶媒と7日~15日の期間で接触させる、請求項1~5のいずれか一項に記載の方法。
- 前記有機成分を溶解することができる前記溶媒が、有機溶剤、無機溶媒、イオン溶液、及びそれらの混合物から選択される、請求項6に記載の方法。
- ステップ(d)の前記洗浄工程が、精製水で1時間~2時間の期間に10~15回の範囲の反復数で繰り返される、請求項1~7のいずれか一項に記載の方法。
- ステップ(e)の前記洗浄工程が、精製水で1~7日の期間に3回以上繰り返して実行される、請求項1~8のいずれか一項に記載の方法。
- ステップ(f)の前記乾燥工程が、1~2日の期間で50℃から100℃の範囲の温度で実行される、請求項1~9のいずれか一項に記載の方法。
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TR2020/09080 | 2020-06-11 | ||
TR2020/09080A TR202009080A2 (tr) | 2020-06-11 | 2020-06-11 | Hayvan kemiğinden ksenogreft üretimi. |
PCT/IB2020/001062 WO2021250439A1 (en) | 2020-06-11 | 2020-12-07 | Production of xenograft from animal bones |
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JP7460048B2 true JP7460048B2 (ja) | 2024-04-02 |
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US (1) | US20230218802A1 (ja) |
EP (1) | EP4164707A1 (ja) |
JP (1) | JP7460048B2 (ja) |
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Citations (6)
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JP2002506677A (ja) | 1998-03-16 | 2002-03-05 | クロスカート インコーポレイテッド | 骨異種移植片 |
JP2008500094A (ja) | 2004-05-25 | 2008-01-10 | エイジェンシー・フォー・サイエンス,テクノロジー・アンド・リサーチ | 移植可能な生体材料およびその調製方法 |
WO2013008959A1 (ko) | 2011-07-08 | 2013-01-17 | 서울대학교산학협력단 | 이종골 유래 골이식재 및 그 제조방법 |
US20150098875A1 (en) | 2013-10-08 | 2015-04-09 | Sigmagraft, Inc. | Process for extracting natural hydroxyaptite granules from bovine bone |
CN108653819A (zh) | 2018-03-12 | 2018-10-16 | 南京航空航天大学 | 短流程制备多孔异种骨骨粉修复材料的方法和由该方法制得的骨修复材料 |
US20190224371A1 (en) | 2015-07-01 | 2019-07-25 | Yaping Li | Degradable Magnesium-containing Calcium Phosphate-Calcium Sulfate Porous Composite Biological Scaffold |
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2020
- 2020-06-11 TR TR2020/09080A patent/TR202009080A2/tr unknown
- 2020-12-07 US US18/009,799 patent/US20230218802A1/en active Pending
- 2020-12-07 EP EP20861968.4A patent/EP4164707A1/en active Pending
- 2020-12-07 WO PCT/IB2020/001062 patent/WO2021250439A1/en unknown
- 2020-12-07 JP JP2022576530A patent/JP7460048B2/ja active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2002506677A (ja) | 1998-03-16 | 2002-03-05 | クロスカート インコーポレイテッド | 骨異種移植片 |
JP2008500094A (ja) | 2004-05-25 | 2008-01-10 | エイジェンシー・フォー・サイエンス,テクノロジー・アンド・リサーチ | 移植可能な生体材料およびその調製方法 |
WO2013008959A1 (ko) | 2011-07-08 | 2013-01-17 | 서울대학교산학협력단 | 이종골 유래 골이식재 및 그 제조방법 |
US20150098875A1 (en) | 2013-10-08 | 2015-04-09 | Sigmagraft, Inc. | Process for extracting natural hydroxyaptite granules from bovine bone |
US20190224371A1 (en) | 2015-07-01 | 2019-07-25 | Yaping Li | Degradable Magnesium-containing Calcium Phosphate-Calcium Sulfate Porous Composite Biological Scaffold |
CN108653819A (zh) | 2018-03-12 | 2018-10-16 | 南京航空航天大学 | 短流程制备多孔异种骨骨粉修复材料的方法和由该方法制得的骨修复材料 |
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US20230218802A1 (en) | 2023-07-13 |
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WO2021250439A1 (en) | 2021-12-16 |
TR202009080A2 (tr) | 2021-12-21 |
JP2023529954A (ja) | 2023-07-12 |
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