JP2015532922A - 生体組織の治療のための方法及びシステム - Google Patents
生体組織の治療のための方法及びシステム Download PDFInfo
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Abstract
Description
用語「心臓組織の損傷」、「心臓組織の傷害」、及び「心血管組織の損傷」は、本明細書において互換的に使用され、心外膜、心内膜、及び/又は心筋の損傷を含む疾病、疾患、傷害又は損傷によって引き起こされた心血管系又は心臓内の任意の異常な組織の領域を意味し、含む。心血管組織損傷の原因の例としては、急性又は慢性ストレス(全身性高血圧、肺高血圧症、弁機能障害等)、冠動脈不全、虚血又は梗塞、炎症性疾患及び心筋症が含まれるがこれらに限定されない。
当技術分野で知られるように、スタチンは、主に、肝臓におけるコレステロール産生のレベルを低下させるように機能する薬剤の一群である。コレステロールのより低いレベルは、コレステロール生合成経路のメバロン酸の産生を制限するスタチンによって達成される。スタチンは、拮抗的にHMG−CoA還元酵素を阻害し、分子が非常に似ているので、スタチンがコレステロール生合成経路でHMG−CoA還元酵素に実際に取って替わり、メバロン酸が生成される速度を減少させ、続いて肝臓でコレステロールが生成される速度を減少させる。
スタチンは、血管壁細胞、及び心血管系への多数の追加的な望ましい影響も有する。これの1つの具体例は、トロンボキサンA2(TXA2)である。スタチンはTXA2の低減を助けることができ、ひいては心血管系における血小板活性化を低下させる。
減少したMMP及び減少したTFはプラークの安定性の増大にもつながり、このことは、プラークの部分が破裂してより小さい管内で詰まる可能性を減少させることにより、脳卒中又は心筋梗塞を予防することに役立つ場合がある。プラークの安定性はさらに、アテローム性動脈硬化を減少させることに役立つ。
RhoA活性化の阻害は又、組織プラスミノーゲン活性化因子(t‐PA)及びプラスミノーゲン活性化抑制因子1型(PAI‐1)の存在に影響を与える。T‐PAは、血餅の分解に関与するタンパク質であり、内皮細胞に見出される。それは酵素としてプラスミノーゲンのプラスミン、血餅の分解(線溶)に関与する主要な酵素への変換を触媒する。
RhoA活性化の阻害は又、心血管系における一酸化窒素(NO)の存在に影響を与える。内皮は周囲の平滑筋にリラックスさせるシグナルを送るためにNOを使い、そのことにより血管が拡張し血流が増大する。NOは、血管平滑筋の収縮及び成長、血小板凝集、及び内皮への白血球接着を抑制することにより、血管の恒常性に寄与する。それらの因子は、典型的にはスタチンの投与で典型的であるような方法で調節されるとき、NOが内皮機能不全の低減に役立つことを可能にするものである。白血球接着の減少は、細胞外マトリックスとともに局所的にともに投与されるとき、スタチンに関連するNOの産生がどのように望ましい炎症の低減に役立つかの具体的な例である。
スタチンの投与は、エンドセリン及びアンジオテンシン受容体の存在に作用し得る。エンドセリン及びアンジオテンシン受容体は又、スタチン投与に関連する次のRhoA活性化の阻害により影響され得る。
C反応性タンパク質(CRP)もスタチン投与によって影響を受ける。CRPは、血液中に見いだされ、それらのレベルは炎症のレベルの差異に応じて逸脱する。CRPレベルは、スタチンの投与に応じて減少する。このことは、スタチンが炎症の低減に与える影響の結果として機能する。
接着分子は、細胞の表面に位置し、炎症及び血管内皮細胞におけるトロンビン形成に関連するタンパク質である。炎症のより多い発生は、細胞接着分子のより多い発生を伴う。スタチンは、内皮上の接着分子の存在を減少させるように機能する。このことは、白血球及びその後のプラークの付着に係る付着機構を除去することによって炎症を軽減するのに役立ち、その結果、アテローム性動脈硬化の機会を低下させる。
Rac‐1は、ヒトの細胞に見いだされるタンパク質である。それは、内皮細胞遊走、細管形成、付着性、透過性において中心的な役割を果たす。Rac‐1の発現は、スタチンの投与に影響される場合があり、具体的に、スタチンによってRac‐1が減少する。Rac‐1の存在が減少することは又、活性酸素種(ROS)の減少をもたらす。ROSは、細胞シグナル伝達及び恒常性において重要な役割を有する化学反応性分子である。
キトサンは哺乳類には存在しないがいくつかのタンパク質分解酵素(リゾチーム、パパイン、ペプシン・・・)によってin vivoで容易に分解し得る。キトサンの生物学的分解が、可変長さの毒性のないオリゴ糖の放出につながり、それは続いてグリコサミノグリカン及び糖タンパク質に組み込まれ、代謝経路へつながり、又は排出されることも見出された。Pangburnら、Lysozyme Degradation of Partially Deacetylated Chitin, its Films and Hydrogels、vol. 3(2)、頁105〜108(1982)。
キトサンは非常によい適合性、特に細胞適合性も示す。キトサンの向上した細胞適合性は、心筋、内皮、及び上皮細胞、線維芽細胞、肝細胞、軟骨細胞、及びケラチノサイトによりin vitroで証明されている。Chateletら、Influence of the Degree of Acetylation on Some Biological Properties of Chitosan Films、Biomaterials、vol. 22(3)、頁261〜268(2001)参照。
キトサンが非常に有利な鎮痛特性(又は効果)を示すことが報告されている。Okamotoらは、酢酸の腹腔内投与による炎症性疼痛に対するキトサンの鎮痛効果を特に検討した。Okamotoら、Analgesic Effects of Chitin and Chitosan、Carbohyd. Poly.、vol. 49、頁249〜252(2002)参照。
キトサン、並びに硫酸化キトサンオリゴマーが、in vitroの試験で抗凝固活性を示すことも報告された。血球膜は負に帯電しているので、キトサンの抗凝固活性は、その正電荷に関連すると考えられる。Raoら、Use of Chitosan as Biomaterial: Studies on its Safety and Hemostatic Potential、J. Biomed. Mat. Res.、vol. 34、頁21〜28(1997)参照。
キチン、キトサン、及びそれらの誘導体の細菌、酵母菌及び真菌等の微生物の異なる群に対する抗菌活性も近年注目されている。キトサンによる微生物細胞の阻害の原因として二つの主な機序が示唆されている。
キトサンは、異なるラジカル種に対して有意な捕捉能も示した。結果は、市販の酸化防止剤を用いて得られたものに匹敵する。Parkら、Free Radical Scavenging Activities of Differently Deacetylated Chitosans、Carbohyd. Polym.、vol. 55(1)、頁17〜22(2004)参照。
キトサンの前述の特性によって、キトサンは、損傷組織の修復を強化することができ、ほとんどの場合において強化するであろう。実際に、キトサンが、PMN、マクロファージ、線維芽細胞及び血管内皮細胞等の免疫細胞及び炎症細胞を活性化することが見出された。Uenoら、Topical Formulations and Wound Healing Applications of Chitosan、Adv. Drug Del. Res.、vol. 52、頁105〜115(2001)参照。
以下の実施例は、当業者が本発明をより明確に理解し及び本発明を実施できるようにするために提供される。それらは本発明の範囲を限定するものと見なされるべきではなく、単に本発明の代表として説明される。
連続してマイクロスフィアを冠動脈に注入することによりCHFが誘導された仔ブタが提供された。
・損傷した生体組織、特に、新血管組織に送達されたときに、新血管形成を誘導し、損傷した心血管組織の生存及び再生を促進する薬理組成物の提供。
・損傷した生体組織、特に、新血管組織に送達されたときに、宿主組織の増殖、バイオリモデリング、及び部位特異的な構造的及び機能的特性を有する心血管組織構造の再生を誘導する細胞外マトリックス(ECM)組成物の提供。
・薬理組成物、特に、ECM組成物を損傷した又は罹患した生体組織に直接に投与するための改良された方法及びシステムの提供。
Claims (11)
- 損傷した生体組織を治療するための流動化された組成物であって、
哺乳動物源由来の細胞外マトリックス(ECM)足場成分を含むECM組成物と、
スタチン及びキチン誘導体から成る群から選択される少なくとも一つの追加の生物活性成分を含む、組成物。 - 前記ECM足場成分が、小腸粘膜下層(SIS)、膀胱粘膜下層(UBS)、膀胱の上皮基底膜(UBM)、肝臓基底膜(LBM)、胃粘膜下層(SS)、動物源由来のコラーゲン、植物源由来のコラーゲン、細胞からの培養物の合成細胞外マトリックス、真皮細胞外マトリックス、皮下細胞外マトリックス、大腸細胞外マトリックス、胎盤細胞外マトリックス、修飾細胞外マトリックス、心臓細胞外マトリックス、および肺細胞外マトリックスから成る群から選択されたECM材料を含むことを特徴とする請求項1に記載の組成物。
- 前記ECM材料が粒子状ECM材料を含むことを特徴とする請求項2に記載の組成物。
- 前記粒子状ECM材料が、約500ミクロン以下の粒径を有することを特徴とする請求項3に記載の組成物。
- 前記粒子状ECM材料の粒径が約20〜300ミクロンの範囲にあることを特徴とする請求項2に記載の組成物。
- 前記ECM組成物が、水及び生理食塩水から成る群から選択される流動化成分を含むことを特徴とする請求項3に記載の組成物。
- 前記ECM組成物が前記流動化成分を約0.001〜200mg/mlの範囲で含むことを特徴とする請求項6に記載の組成物。
- 前記スタチンが、アトルバスタチン、セリバスタチン、フルバスタチン、ロバスタチン、メバスタチン、ピタバスタチン、プラバスタチン、ロスバスタチン、及びシンバスタチンから成る群から選択されることを特徴とする請求項1に記載の組成物。
- 前記キチン誘導体がキトサンを含むことを特徴とする請求項1に記載の組成物。
- 第1の生物活性成分が、抗生物質、抗真菌剤、抗ウイルス剤、抗疼痛剤、麻酔薬、鎮痛薬、ステロイド性抗炎症薬、非ステロイド性抗炎症薬、抗悪性腫瘍薬、鎮痙薬、細胞‐細胞外マトリックス相互作用のモジュレータ、タンパク質、ホルモン、酵素及び酵素阻害剤、抗凝固剤、抗血栓剤、DNA、RNA、修飾DNA及びRNA、NSAID、DNAの阻害剤、ポリペプチド、オリゴヌクレオチド、ポリヌクレオチド、核タンパク質、及び血管拡張剤から成る群から選択される薬物を含むことを特徴とする請求項1に記載の組成物。
- 前記第1の生物活性成分が、ヒト胚幹細胞、胎児細胞、胎児心筋細胞、筋線維芽細胞、間葉系幹細胞、自家移植拡張心筋細胞、脂肪細胞、全能性細胞、多能性細胞、血液幹細胞、筋芽細胞、成体幹細胞、骨髄細胞、間葉系細胞、胚性幹細胞、実質細胞、上皮細胞、内皮細胞、中皮細胞、線維芽細胞、筋線維芽細胞、骨芽細胞、軟骨細胞、外因性細胞、内因性細胞、幹細胞、造血性幹細胞、多能性幹細胞、骨髄由来前駆細胞、前駆細胞、心筋細胞、骨格細胞、未分化細胞、多能性前駆細胞、単能性前駆細胞、単球、心筋細胞、心筋芽細胞、骨格筋芽細胞、マクロファージ、毛細血管内皮細胞、異種細胞、及び同種細胞から成る群から選択される細胞を含むことを特徴とする請求項1に記載の組成物。
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Patent Citations (1)
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WO2010096458A1 (en) * | 2009-02-18 | 2010-08-26 | Cormatrix Cardiovascular, Inc. | Compositions and methods for preventing cardiac arrhythmia |
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AU2013318551B2 (en) | 2018-06-14 |
US20130058904A1 (en) | 2013-03-07 |
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SG11201408808WA (en) | 2015-01-29 |
US20140087000A1 (en) | 2014-03-27 |
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EP2887948A4 (en) | 2016-04-13 |
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CN104703614A (zh) | 2015-06-10 |
WO2014046744A1 (en) | 2014-03-27 |
BR112015006512A2 (pt) | 2017-08-08 |
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