JP2022512963A - 再生性のアブスコパル効果 - Google Patents
再生性のアブスコパル効果 Download PDFInfo
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Abstract
Description
参考文献
本開示およびその利点を詳細に記載してきたが、添付の請求項によって定義される構想の趣旨および範囲から逸脱することなく、様々な変更、置換および改変が本明細書中で行われ得ることが理解されるべきである。さらに、本願の範囲は、本明細書に記載されたプロセス、機械、製造、組成物、手段、方法および工程の特定の実施形態に限定されると意図されていない。当業者は、本明細書中に記載される対応する実施形態と実質的に同じ機能を果たすまたは実質的に同じ結果を達成する、すでに現在存在しているまたは後に開発される、プロセス、機械、製造、組成物、手段、方法または工程が本開示に従って利用され得ることを本開示からすぐに認識する。したがって、添付の請求項は、そのようなプロセス、機械、製造、組成物、手段、方法または工程の範囲内に含めるように意図されている。
Claims (85)
- 個体の第1の組織部位において再生を刺激する方法であって、前記方法は、線維芽細胞および/または脱分化した線維芽細胞ならびに必要に応じて幹細胞を含む少なくとも1つの再生組成物を第2の組織部位に投与する工程を含み、前記第2の組織部位は、前記個体の前記第1の組織部位と同じ組織型を含む、方法。
- 前記組成物の投与が、全身注射、局所注射、全身送達および/または局所送達を含む、請求項1に記載の方法。
- 前記組成物の投与が、少なくとも1回の投与または2、3、4、5、6、7、8、9、10回もしくはそれ以上の投与を含む、請求項1または2に記載の方法。
- 前記第1の組織が、部分的または完全な機能喪失を有する、請求項1~3のいずれか1項に記載の方法。
- 機能喪失が、前記組織における細胞死、組織壊死、萎縮、線維症、炎症、脂肪沈着、変性分子の生成、弾性低下、神経変性、自己免疫、補体活性化、軟骨減少、靭帯断裂、筋肉断裂、結合組織の減少、新生物またはそれらの組み合わせを含む、請求項4に記載の方法。
- 前記組織が、筋組織、結合組織、上皮組織、内皮組織、神経組織、脂肪組織、皮膚組織、肺組織、肝組織、膀胱組織、腎組織、心臓組織、胃組織、腸組織、脊髄組織、眼組織、線維組織、網、リンパ組織、骨髄またはそれらの組み合わせを含む、請求項1~5のいずれか1項に記載の方法。
- 前記組織が、内皮細胞、上皮細胞、皮膚細胞、内胚葉細胞、中胚葉細胞、線維芽細胞、骨細胞、軟骨細胞、ナチュラルキラー細胞、樹状細胞、肝臓細胞、膵臓細胞、間質細胞、唾液腺粘液細胞、唾液腺漿液細胞、フォンエブネル腺細胞、乳腺細胞、涙腺細胞、耳道腺細胞、エクリン汗腺暗細胞、エクリン汗腺明細胞、アポクリン汗腺細胞、モル腺細胞、皮脂腺細胞.ボーマン腺細胞、ブルンネル腺細胞、精嚢細胞、前立腺細胞、尿道球腺細胞、バルトリン腺細胞、リトル腺細胞、子宮内膜細胞、孤立した杯細胞、胃壁の粘膜細胞、胃腺酵素原細胞、胃腺酸分泌細胞、膵腺房細胞、パネート細胞、II型肺胞細胞、クララ細胞、成長ホルモン産生細胞、乳腺刺激ホルモン産生細胞、甲状腺刺激ホルモン産生細胞、性腺刺激ホルモン産生細胞、副腎皮質刺激ホルモン産生細胞、脳下垂体中葉細胞、大細胞神経分泌細胞、腸細胞、気道細胞、甲状腺上皮細胞、傍濾胞細胞、副甲状腺細胞、上皮小体主細胞、好酸性細胞、副腎細胞、クロム親和細胞、ライディッヒ細胞、内卵胞膜細胞、黄体細胞、顆粒膜黄体細胞、卵胞膜黄体細胞、傍糸球体細胞、緻密斑細胞、周血管極細胞、メサンギウム細胞、血管内皮有窓細胞およびリンパ管内皮有窓細胞、血管内皮連続細胞およびリンパ管内皮連続細胞、血管内皮脾細胞およびリンパ管内皮脾細胞、滑膜細胞、漿膜細胞(腹膜腔、胸膜腔および囲心腔の内壁)、扁平上皮細胞、円柱細胞、暗細胞、前庭膜細胞(耳の内リンパ腔の内壁)、血管条基底細胞、血管条周辺細胞(耳の内リンパ腔の内壁)、クラウディウス細胞、ベッチャー細胞、脈絡叢細胞、軟膜クモ膜扁平上皮細胞、色素性毛様体上皮細胞、非色素性毛様体上皮細胞、角膜内皮細胞、ペグ細胞、気道線毛細胞、卵管繊毛細胞、子宮内膜繊毛細胞、精巣網繊毛細胞、精巣輸出管繊毛細胞、繊毛性上衣細胞、表皮角化細胞、表皮基底細胞、手指爪および足指爪のケラチノサイト、爪床基底細胞、髄様毛幹細胞、皮質毛幹細胞、クチクラ毛幹細胞、クチクラ毛根鞘細胞、ハクスリー層の毛根鞘細胞、ヘンレ層の毛根鞘細胞、外毛根鞘細胞、毛母細胞、重層扁平上皮の表面上皮細胞、上皮の基底細胞、泌尿器上皮細胞、耳のコルチ器の内有毛細胞、耳のコルチ器の外有毛細胞、嗅上皮の基底細胞、低温感受性一次感覚ニューロン、感熱性一次感覚ニューロン、表皮のメルケル細胞、嗅覚受容神経、疼痛感受性一次感覚ニューロン、光受容体桿体細胞、光受容体青色感受性錐体細胞、光受容体緑色感受性錐体細胞、光受容体赤色感受性錐体細胞、固有受容性一次感覚ニューロン、触覚感受性一次感覚ニューロン、I型頚動脈小体細胞、II型頚動脈小体細胞(血液pHセンサー)、耳の前庭器のI型有毛細胞(加速および重力)、耳の前庭器のII型有毛細胞、I型味蕾細胞 コリン作動性神経細胞、アドレナリン作動性神経細胞、ペプチド作動性神経細胞、コルチ器の内柱細胞、コルチ器の外柱細胞、コルチ器の内支持細胞、コルチ器の外支持細胞、コルチ器の境界細胞、コルチ器のヘンゼン細胞、前庭器支持細胞、味蕾支持細胞、嗅上皮支持細胞、シュワン細胞、衛星細胞、腸グリア細胞、アストロサイト、ニューロン、乏突起膠細胞、紡錘状ニューロン、前水晶体上皮細胞、クリスタリン含有水晶体線維細胞、肝細胞、脂肪細胞、白色脂肪細胞、褐色脂肪細胞、肝臓脂質細胞、腎糸球体壁細胞、腎糸球体ポドサイト、腎近位尿細管刷子縁細胞、ヘンレ係蹄の細い部分の細胞、腎遠位尿細管細胞、腎集合管細胞、I型肺細胞、膵管細胞、平滑筋導管細胞、導管細胞、腸刷子縁細胞、外分泌腺線条導管細胞、胆嚢上皮細胞、精巣輸出管非線毛細胞、精巣上体主細胞、精巣上体基底細胞、エナメル芽細胞上皮細胞、半月面上皮細胞、コルチ器歯間上皮細胞、疎性結合組織線維芽細胞、角膜実質細胞、腱線維芽細胞、骨髄細網組織線維芽細胞、非上皮線維芽細胞、周皮細胞、髄核細胞、セメント芽細胞/セメント細胞、象牙芽細胞、オドントサイト、硝子軟骨の軟骨細胞、線維軟骨の軟骨細胞、弾性軟骨の軟骨細胞、骨芽細胞、骨細胞、破骨細胞、骨細胞前駆細胞、硝子体細胞、星細胞(耳)、肝星細胞(伊東細胞)、膵星細胞、赤筋骨格筋細胞、白筋骨格筋細胞、中間骨格筋細胞、筋紡錘の核袋細胞、筋紡錘の核鎖細胞、衛星細胞、通常の心筋細胞、結節心筋細胞、プルキンエ線維細胞、平滑筋細胞、虹彩の筋上皮細胞、外分泌腺の筋上皮細胞、網状赤血球、巨核球、単球、結合組織マクロファージ.上皮ランゲルハンス細胞、樹状細胞、ミクログリア細胞、好中球、好酸球、好塩基球、マスト細胞、ヘルパーT細胞、サプレッサーT細胞、細胞傷害性T細胞、ナチュラルキラーT細胞、B細胞、ナチュラルキラー細胞、メラノサイト、網膜色素上皮細胞、卵原細胞/卵母細胞、精子細胞、精母細胞、精原細胞、精子、卵胞細胞、セルトリ細胞、胸腺上皮細胞、間質腎臓細胞およびそれらの組み合わせからなる群より選択される1つ以上の細胞を含む、請求項1~6のいずれか1項に記載の方法。
- 前記再生組成物が、少なくとも1つの成長因子を含む、請求項1~7のいずれか1項に記載の方法。
- 少なくとも1つの成長因子が、AM、Ang、BMP、BDNF、EGF、Epo、FGF、GNDF、G-CSF、GM-CSF、GDF-9、HGF、HDGF、IGF、遊走刺激因子、GDF-8、GDF-11、GDF-15、MGF、NGF、PlGF、PDGF、Tpo、TGF-アルファ、TGF-ベータ、TNF-アルファ、VEGF、Wntタンパク質、インターロイキン、IL-1アルファ、IL-1ベータ、IL-1F1、IL-1F2、IL-1F3、IL-1F4、IL-1F5、IL-1F6、IL-1F7、IL-1F8、IL-1F9、IL-2、IL-3、IL-4、IL-5、IL-6、IL-7、IL-8、IL-9、IL-10、IL-11、IL-12、35kDaアルファサブユニット、IL-12、40kDaベータサブユニット、IL-13、IL-14、IL-15、IL-16、IL-17A、IL-17B、IL-17C、IL-17D、IL-17E、IL-17Fアイソフォーム1、IL-17Fアイソフォーム2、IL-18、IL-19、IL-20、IL-21、IL-22、IL-23 p19サブユニット、IL-23 p40サブユニット、IL-24、IL-25、IL-26、IL-27B、IL-27-p28、IL-28A、IL-28B、IL-29、IL-30、IL-31、IL-32、IL-33、IL-34、IL-35、IL-36アルファ、IL-36ベータ、IL-36ガンマに対する可溶性レセプター、インターフェロン(IFN)、IFN-アルファ、IFN-ベータ、IFN-ガンマ、IFN-ラムダ1、IFN-ラムダ2、IFN-ラムダ3、IFN-K、IFN-イプシロン、IFN-カッパー、IFN-タウ、IFN-デルタ、IFN-ゼータ、IFN-オメガ、IFN-vに対する可溶性レセプター、インスリン、プロインスリン、インスリンに対するレセプター、レプチン(LEP)およびそれらの組み合わせからなる群より選択される、請求項8に記載の方法。
- 前記再生組成物が、多血小板血漿を含む、請求項1~9のいずれか1項に記載の方法。
- 前記多血小板血漿が、血小板溶解物を含む、請求項10に記載の方法。
- 前記多血小板血漿が、末梢血に由来する、請求項10に記載の方法。
- 前記多血小板血漿が、臍帯血に由来する、請求項10に記載の方法。
- 前記再生組成物が、少なくとも1つの再生性細胞に由来する1つ以上のエクソソームを含む、請求項1~13のいずれか1項に記載の方法。
- 前記再生性細胞が、幹細胞および/または線維芽細胞である、請求項14に記載の方法。
- 前記線維芽細胞が、包皮、脂肪組織、胎盤、耳垂、網、ワルトンゼリーおよびそれらの組み合わせからなる群より選択される組織起源に由来する、請求項15に記載の方法。
- 前記エクソソームが、2nm~200nmのサイズを有する、請求項14~16のいずれか1項に記載の方法。
- 前記エクソソームが、30~150nmのサイズを有する、請求項14~17のいずれか1項に記載の方法。
- 前記エクソソームが、リン脂質、ホスファチジルセリン、ホスファチジルイノシトール、ホスファチジルコリン、スフィンゴミエリン、セラミド、糖脂質、セレブロシド、ステロイド、コレステロールおよびそれらの組み合わせからなる群より選択される少なくとも1つの脂質を含む、請求項14~18のいずれか1項に記載の方法。
- 前記エクソソームが、少なくとも1つの脂質ラフトを含む、請求項14~19のいずれか1項に記載の方法。
- 前記エクソソームが、CD9、CD63、CD81、ANXA2、ENO1、HSP90AA1、EEF1A1、YWHAE、SDCBP、PDCD6IP、ALB、YWHAZ、EEF2、ACTG1、LDHA、HSP90AB1、ALDOA、MSN、ANXA5、PGK1、CFL1およびそれらの組み合わせからなる群より選択される1つ以上の抗原マーカーを前記エクソソームの表面上に含む、請求項14~20のいずれか1項に記載の方法。
- 前記再生組成物が、1つ以上の線維芽細胞を含む、請求項1~21のいずれか1項に記載の方法。
- 前記線維芽細胞が、包皮、脂肪組織、胎盤、耳垂、脂肪組織、網、ワルトンゼリーおよびそれらの組み合わせからなる群より選択される組織起源に由来する、請求項22に記載の方法。
- 前記線維芽細胞が、NANOG、OCT-4、SSEA-4、幹細胞因子レセプターおよびそれらの組み合わせからなる群より選択される少なくとも1つのマーカーを発現する、請求項22または23に記載の方法。
- 前記再生組成物が、1つ以上の幹細胞を含む、請求項1~24のいずれか1項に記載の方法。
- 前記幹細胞が、多能性幹細胞を含む、25に記載の方法。
- 前記多能性幹細胞が、胚性幹細胞、単為生殖由来の幹細胞、誘導性多能性幹細胞、体細胞核移植由来の幹細胞、細胞質移植由来の幹細胞、刺激惹起性多能性獲得およびそれらの組み合わせからなる群より選択される、請求項26に記載の方法。
- 前記幹細胞が、造血幹細胞を含む、25に記載の方法。
- 前記造血幹細胞が、免疫不全の宿主において多系列の再構成が可能である、請求項28に記載の方法。
- 前記造血幹細胞が、c-kit、Sca-1、CD34、CD133およびそれらの組み合わせからなる群より選択されるタンパク質のうちの少なくとも1つを発現する、請求項28に記載の方法。
- 前記造血幹細胞が、Sca-1タンパク質を発現する、請求項28~30のいずれか1項に記載の方法。
- 前記造血幹細胞が、CD34を発現する、請求項28~31のいずれか1項に記載の方法。
- 前記造血幹細胞が、CD133を発現する、請求項28~32のいずれか1項に記載の方法。
- 前記造血幹細胞が、1つ以上の系列マーカーの発現を欠く、請求項28に記載の方法。
- 前記造血幹細胞が、CD38、CD14、CD16、CD56またはそれらの組み合わせの発現を欠く、請求項28に記載の方法。
- 前記造血幹細胞が、c-kitの発現が陽性であり、Sca-1の発現が陽性であり、かつ/または系列マーカーの発現を実質的に欠く、請求項28に記載の方法。
- 前記造血幹細胞が、末梢血、動員末梢血、骨髄、臍帯血、脂肪間質血管細胞群、前駆細胞に由来するものおよびそれらの組み合わせからなる群より選択される起源に由来する、請求項28に記載の方法。
- 前記造血前駆細胞が、多能性幹細胞である、請求項32に記載の方法。
- 前記幹細胞が、間葉系幹細胞を含む、請求項25に記載の方法。
- 前記間葉系幹細胞が、プラスチック接着性である、請求項39に記載の方法。
- 前記間葉系幹細胞が、CD73、CD90、CD105およびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項39または40に記載の方法。
- 前記間葉系幹細胞が、CD14、CD45、CD34およびそれらの組み合わせからなる群より選択されるマーカーの発現を欠く、請求項39、40または41に記載の方法。
- 前記間葉系幹細胞が、骨髄、末梢血、脂肪組織、動員末梢血、臍帯血、ワルトンゼリー、臍帯組織、骨格筋組織、上皮下臍帯、子宮内膜組織、月経血、卵管組織およびそれらの組み合わせからなる群より選択される組織に由来する、請求項39に記載の方法。
- 臍帯組織に由来する前記間葉系幹細胞が、酸化低密度リポタンパク質レセプター1、ケモカインレセプターリガンド3、顆粒球走化性タンパク質およびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項43に記載の方法。
- 臍帯組織由来の前記間葉系幹細胞が、CD117、CD31、CD34、CD45およびそれらの組み合わせからなる群より選択されるマーカーを発現しない、請求項43または44に記載の方法。
- 臍帯組織由来の前記間葉系幹細胞が、ヒト線維芽細胞と比べて高レベルのインターロイキン8および/またはレティキュロン1を発現する、請求項43~45のいずれか1項に記載の方法。
- 臍帯組織由来の前記間葉系幹細胞が、CD10、CD13、CD44、CD73、CD90およびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項43~46のいずれか1項に記載の方法。
- 前記臍帯組織由来の細胞が、MCP-1、MIP1ベータ、IL-6、IL-8、GCP-2、HGF、KGF、FGF、HB-EGF、BDNF、TPO、RANTES、TIMP1およびそれらの組み合わせからなる群より選択される因子を分泌する、請求項43~47のいずれか1項に記載の方法。
- 前記臍帯組織由来の細胞が、TRA1-60、TRA1-81、SSEA3、SSEA4、NANOGおよびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項43~48のいずれか1項に記載の方法。
- 前記臍帯組織由来の間葉系幹細胞が、培養中に自己複製および拡大が可能な、血液を実質的に含まない臍帯組織から単離された、単離された臍帯組織細胞である、請求項43~49のいずれか1項に記載の方法。
- 前記臍帯組織由来の細胞が、アルカリホスファターゼ染色陽性である、請求項43~50のいずれか1項に記載の方法。
- 前記帯組織由来の間葉系幹細胞が、培養中に少なくとも20回の倍加を起こすことができる、請求項43に記載の方法。
- 前記帯組織由来の間葉系幹細胞が、継代の際に正常核型を維持する、請求項49に記載の方法。
- 前記臍帯組織由来の間葉系幹細胞が、CD10、CD13、CD44、CD73、CD90、PDGFr-アルファ、PD-L2、HLA-A,B,Cおよびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項43~53のいずれか1項に記載の方法。
- 前記帯組織由来の間葉系幹細胞が、CD31、CD34、CD45、CD80、CD86、CD117、CD141、CD178、B7-H2、HLA-G、HLA-DR,DP,DQおよびそれらの組み合わせからなる群より選択される1つ以上のマーカーを発現しない、請求項43~51のいずれか1項に記載の方法。
- 前記骨髄由来の間葉系幹細胞が、LFA-3、ICAM-1、PECAM-1、P-セレクチン、L-セレクチン、CD49b/CD29、CD49c/CD29、CD49d/CD29、CD29、CD18、CD61、6-19、トロンボモジュリン、テロメラーゼ、CD10、CD13、CD34、CD56、CD117、インテグリンベータおよびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項43に記載の方法。
- 前記骨髄間葉系幹細胞が、CD10を発現しない、請求項43または56のいずれか1項に記載の方法。
- 前記骨髄間葉系幹細胞が、CD2、CD5、CD14、CD19、CD33、CD45および/またはDRIIのうちの少なくとも1つを発現しない、請求項43、56または57のいずれか1項に記載の方法。
- 前記骨髄間葉系幹細胞が、CD13、CD34、CD56、CD90、CD117および/またはネスチンのうちの少なくとも1つを発現する、請求項43、56、57または58のいずれか1項に記載の方法。
- 前記骨髄由来の間葉系幹細胞が、間葉系幹細胞の前駆細胞である、請求項43~59のいずれか1項に記載の方法。
- 前記間葉系前駆細胞が、STRO-1を発現している細胞が濃縮された骨髄間葉系幹細胞の集団を含む、請求項60に記載の方法。
- 前記間葉系前駆細胞が、STRO-1とVCAM-1の両方を発現している、請求項60または61のいずれか1項に記載の方法。
- 前記STRO-1を発現している細胞が、CBFA-1、II型コラーゲン、PPAR.ガンマ2、オステオポンチン、オステオカルシン、副甲状腺ホルモンレセプター、レプチン、H-ALBP、アグリカン、Ki67、グリコホリンAおよびそれらの組み合わせからなる群より選択される少なくとも1つのマーカーが陰性である、請求項60~62のいずれか1項に記載の方法。
- 前記骨髄間葉系幹細胞が、CD14、CD34および/またはCD45のうちの少なくとも1つの発現を欠く、請求項60に記載の方法。
- 前記STRO-1を発現している細胞が、VCAM-1、TKY-1、CD146、STRO-2およびそれらの組み合わせからなる群より選択されるマーカーが陽性である、請求項61~64のいずれか1項に記載の方法。
- 前記骨格筋幹細胞が、CD13、CD34、CD56、CD117およびそれらの組み合わせからなる群より選択されるマーカーを発現する、請求項43に記載の方法。
- 前記骨格筋間葉系幹細胞が、CD10を発現しない、請求項43または66のいずれか1項に記載の方法。
- 前記骨格筋間葉系幹細胞が、CD2、CD5、CD14、CD19、CD33、CD45および/またはDRIIのうちの少なくとも1つを発現しない、請求項43、66または67のいずれか1項に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、CD29、CD73、CD90、CD166、SSEA4、CD9、CD44、CD146、CD105およびそれらの組み合わせからなる群より選択されるマーカーを有する、請求項43に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、CD45、CD34、CD14、CD79、CD106、CD86、CD80、CD19、CD117、Stro-1、HLA-DRおよびそれらの組み合わせからなる群より選択されるマーカーを発現しない、請求項43または69のいずれか1項に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、CD29、CD73、CD90、CD166、SSEA4、CD9、CD44、CD146および/またはCD105のうちの少なくとも1つを発現する、請求項43、69または70のいずれか1項に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、CD45、CD34、CD14、CD79、CD106、CD86、CD80、CD19、CD117、Stro-1および/またはHLA-DRのうちの少なくとも1つを発現しない、請求項43または69~71のいずれか1項に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、SOX2陽性である、請求項43または69~72のいずれか1項に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、OCT4陽性である、請求項43または69~73のいずれか1項に記載の方法。
- 前記上皮下臍帯由来の間葉系幹細胞が、OCT4陽性かつSOX2陽性である、請求項43または69~74のいずれか1項に記載の方法。
- 前記再生組成物が、1つ以上の線維芽細胞由来のアポトーシス小胞を含む、請求項1~75のいずれか1項に記載の方法。
- 前記再生組成物が、線維芽細胞由来のmiRNAを含む、請求項1~76のいずれか1項に記載の方法。
- 前記線維芽細胞由来のmiRNAが、エクソソームに含まれている、請求項77に記載の方法。
- 前記線維芽細胞由来のmiRNAが、アポトーシス小体に含まれている、請求項77に記載の方法。
- 前記線維芽細胞由来のmiRNAが、血漿中に循環している、請求項77に記載の方法。
- 1つ以上の遠隔再生効果の増強が、1つ以上のエピジェネティック作用性組成物の全身投与によって達成される、請求項1~80のいずれか1項に記載の方法。
- 全身投与が、前記再生組成物の投与部位または異なる部位において行われる、請求項81に記載の方法。
- 前記エピジェネティック作用性組成物が、1つ以上のヒストン脱アセチル化酵素阻害剤を含む、請求項81または82に記載の方法。
- 前記エピジェネティック作用性組成物が、1つ以上のDNAメチルトランスフェラーゼ阻害剤を含む、請求項81=83のいずれか1項に記載の方法。
- 前記第1の組織が、変性している、請求項4に記載の方法。
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