JP5674256B2 - 細胞含有流動性組成物の最小侵襲投与のための材料および方法 - Google Patents
細胞含有流動性組成物の最小侵襲投与のための材料および方法 Download PDFInfo
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Description
本発明は、移植可能な流動性組成物中、該組成物上、又は該組成物内に移植した細胞が、例えば、血管内投与、並びに血管を含むが、これに限定されない管状の解剖学的構造の管腔外面における、該外面に隣接した、又は該外面近くにおける血管周囲の沈着のような、多くの低侵襲的送達様式のために処方できるという発見を利用するものである。本明細書では、管状の解剖学的構造の外面への、該外面上への、又は該外面周囲への低侵襲送達も想定している。血管の場合、本発明の材料及び方法は、血管介入又は心血管疾病に関連した臨床的続発症の治療及び管理に適している。
本実施例は、動物の試験対象における血管介入に関連した臨床的続発症の発生率を低下させるために、本発明の好ましい実施形態を試験及び使用する実験プロトコールを提供する。標準的な外科手技では、大腿動脈上で実施する経皮バルーン血管形成術及びステント留置により、内腔面に損傷が誘導される。次に、本発明の移植可能な流動性組成物を、血管形成術及びステント処置血管の部位に隣接した血管周囲腔内に留置する。以下では、代表的な一工程の詳細を説明する。前述の通り、移植可能な流動性組成物の配置及び処方は変更することができる。
前述の通り本発明の流動性組成物を使用して処置した対象は、閉塞性血栓症の減少、開存率の上昇、狭窄の減少、内膜過形成の減少、並びに急性及び慢性の管腔及び/又は血管周囲の炎症の低下を含むが、これらに限定されない、血管介入に関連した臨床的続発症の発生率の低下の1種以上の徴候を示すことが期待される。
本実施例は、ヒト臨床的試験対象の血管介入に関連した臨床的続発症の発生率を低下させるために、移植した血管内皮細胞及び微粒子形態の生体適合性基質を含む流動性組成物を試験及び使用する実験プロトコールを提供する。標準的な外科手技では、内科医指定による経皮バルーン血管形成術及びステント留置術を実施して、臨床的症状を緩和する。次に、移植可能な流動性組成物を、血管形成術及びステント留置部位における、該部位に隣接する、又は該部位の近くにおける血管周囲腔内に配置する。以下では、代表的な一工程を詳細に説明する。前述の通り、移植可能な流動性組成物の配置及び処方は、熟練した開業医により日常的な方法で変更することができる。
前述の通り本発明の流動性組成物を使用して処置した対象は、閉塞性血栓症、再狭窄、内膜過形成、並びに急性及び慢性炎症を含むが、これらに限定されない、血管介入に関連した臨床的続発症の発生率の低下の1種以上の徴候を示すことが期待される。
本実施例は、動物試験対象の骨盤及びその周囲における癒着の発生率を低下させるために、生体適合性微粒子基質及び移植内皮細胞又は内皮様細胞を含む流動性組成物を試験及び使用する実験プロトコールを提供する。本発明の移植可能な流動性組成物及び方法による卵管再建手術の後、実験用ラットモデル(変更子宮角モデル、J. Invest. Surg. 7: 409−15 (1994))を使用して、術後癒着の処置を試験する。子宮角の両側を擦過し、互いに縫合する。14日後、再開腹時に、縫合した子宮角の両側の間の強固な接続を切断する。そして、子宮角の片側及び周囲には、前述の通り本発明の移植可能な流動性組成物を適用する。子宮角の反対側は、対照として移植可能な流動性組成物を受容しない。一定の時間にわたり、癒着の存在又は非存在を監視する。本発明の移植可能な流動性組成物で処置したラットでは、骨盤及びその周囲における癒着の発生率が低減されることが期待される。
本実施例は、動物試験対象におけるファロピウス管閉塞の発生率を低下させるために、生体適合性微粒子基質と移植内皮又は内皮様細胞を試験及び使用する、実験プロトコールを提供する。実験用ウサギモデル(J. Vase. Interv. Radiol. 13: 399−404 (2002))を使用して、本発明の移植可能な流動性組成物及び方法によるファロピウス管閉塞の処置を試験する。透視下で、同軸技法を使用して、右及び左ファロピウス管の経膣カテーテル法を実施する。活性電極カテーテルから突出する金属ガイドワイヤを使用して、RF電気凝固法を実施する。一方のファロピウス管及び周囲には、前述の通り本発明の移植可能な流動性組成物を適用する。他方のファロピウス管は、対照として移植可能な流動性組成物を受容しない。一定の時間にわたり、卵管の開存性及び組織学的変化を評価する。本発明の移植可能な流動性組成物で処置したウサギでは、ファロピウス管及びそれらの周囲における閉塞、狭窄及び壊死の発生率が低減されることが期待される。
Claims (21)
- 管状の解剖学的構造の管腔内側上の損傷又は病変部位を処置するための流動性組成物であって、該流動性組成物は、微粒子形態の生体適合性基質及び細胞を含み、且つ損傷又は病変部位を処置する上で有効な量で、該損傷若しくは病変部位において、又は該部位の近くにおいて、管腔外面へと経皮注入によって送達され、ここで、該細胞は、血管内皮細胞であり、該管状の解剖学的構造は血管である、流動性組成物。
- 前記生体適合性基質が粒子又はマイクロキャリアを含む、請求項1に記載の流動性組成物。
- 前記粒子又はマイクロキャリアが更に、ゼラチン、コラーゲン、フィブロネクチン、フィブリン、ラミニン又は結合ペプチドを含む、請求項2に記載の流動性組成物。
- 前記結合ペプチドがアルギニン−グリシン−アスパラギン酸(RGD)配列のペプチドを含む、請求項3に記載の流動性組成物。
- 粒子又はマイクロキャリアが20ミクロン〜500ミクロンの直径を有する、請求項2に記載の流動性組成物。
- 粒子又はマイクロキャリアが200ミクロンの直径を有する、請求項2に記載の流動性組成物。
- 前記有効量により、損傷又は病変部位における平滑筋細胞の増殖が低減されるか、閉塞性血栓症が低減されるか、内膜過形成が低減されるか、狭窄又は再狭窄が低減されるか、急性炎症又は慢性炎症が低減されるか、あるいは血管拡張又は血管痙攣が低減される、請求項1に記載の流動性組成物。
- 前記細胞が、コンフルエントな細胞集団;ほぼコンフルエントな細胞集団;およびコンフルエント後の細胞集団からなる群より選択される、請求項1に記載の流動性組成物。
- 生体適合性タンパク質粒子に移植された、指数増殖期でない生存細胞を含む、管状の解剖学的構造の管腔内側上の損傷又は病変部位を処置するための流動性組成物であって、該流動性組成物は、該損傷若しくは病変部位において、又は該部位の近くにおいて、管腔外面へと経皮注入によって送達され、ここで、該細胞は、血管内皮細胞であり、該管状の解剖学的構造は血管である、流動性組成物。
- 前記粒子の直径が、20μm〜1000μmの範囲にある、請求項9に記載の流動性組成物。
- 前記粒子の直径が、100μm〜500μmである、請求項10に記載の流動性組成物。
- 前記タンパク質が、ゼラチン、コラーゲン、フィブロネクチン、フィブリン、およびラミニンからなる群より選択される、請求項9に記載の流動性組成物。
- 前記細胞はヒトのものである、請求項9に記載の流動性組成物。
- 前記細胞は、コンフルエントな細胞集団、ほぼコンフルエントな細胞集団およびコンフルエント後の細胞集団からなる群より選択される、請求項9に記載の流動性組成物。
- 前記細胞は、硫酸ヘパラン、TGF−β1、およびb−FGFを産生する、請求項9に記載の流動性組成物。
- さらに、ヘパリン、硫酸ヘパラン、増殖因子、抗増殖剤、および抗腫瘍剤からなる群より選択されるメンバーを含む、請求項9に記載の流動性組成物。
- 前記増殖因子は、TGF−β1またはb−FGFである、請求項16に記載の流動性組成物。
- 前記メンバーは、硫酸ヘパランである、請求項16に記載の流動性組成物。
- 前記流動性組成物は、少なくとも35ミリグラムの用量で投与されることを特徴とする、請求項9に記載の流動性組成物。
- 前記生体適合性粒子は、適切な量の付着因子をさらに含む、請求項9に記載の流動性組成物。
- 前記付着因子は、フィブロネクチン、フィブリンゲル、および共有結合した細胞接着リガンドからなる群より選択される、請求項20に記載の流動性組成物。
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US63415504P | 2004-12-08 | 2004-12-08 | |
US60/634,155 | 2004-12-08 | ||
US66385905P | 2005-03-21 | 2005-03-21 | |
US60/663,859 | 2005-03-21 | ||
US68205405P | 2005-05-18 | 2005-05-18 | |
US60/682,054 | 2005-05-18 | ||
PCT/US2005/043844 WO2006062871A2 (en) | 2004-12-08 | 2005-12-06 | Materials and methods for minimally-invasive administration of a cell-containing flowable composition |
USPCT/US2005/043967 | 2005-12-06 | ||
USPCT/US2005/044090 | 2005-12-06 | ||
PCT/US2005/044090 WO2006062962A2 (en) | 2004-12-08 | 2005-12-06 | Materials and methods for treating and managing plaque disease |
PCT/US2005/043967 WO2006062909A2 (en) | 2004-12-08 | 2005-12-06 | Methods and compositions for enhancing vascular access |
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JP2012110766A Division JP2012148164A (ja) | 2004-12-08 | 2012-05-14 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2012256581A Division JP2013039431A (ja) | 2004-12-08 | 2012-11-22 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2014239567A Division JP2015042682A (ja) | 2004-12-08 | 2014-11-27 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
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JP2008532565A JP2008532565A (ja) | 2008-08-21 |
JP2008532565A5 JP2008532565A5 (ja) | 2009-01-15 |
JP5674256B2 true JP5674256B2 (ja) | 2015-02-25 |
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JP2007545559A Pending JP2008522738A (ja) | 2004-12-08 | 2005-12-06 | プラーク疾患を処置および監視するための材料および方法 |
JP2007545539A Expired - Fee Related JP5674256B2 (ja) | 2004-12-08 | 2005-12-06 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2007545545A Pending JP2008522735A (ja) | 2004-12-08 | 2005-12-06 | 血管アクセスを強化するための方法および組成物 |
JP2012110766A Pending JP2012148164A (ja) | 2004-12-08 | 2012-05-14 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2012111453A Pending JP2012176260A (ja) | 2004-12-08 | 2012-05-15 | 血管アクセスを強化するための方法および組成物 |
JP2012256574A Pending JP2013056202A (ja) | 2004-12-08 | 2012-11-22 | 血管アクセスを強化するための方法および組成物 |
JP2012256581A Pending JP2013039431A (ja) | 2004-12-08 | 2012-11-22 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2014239567A Withdrawn JP2015042682A (ja) | 2004-12-08 | 2014-11-27 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
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JP2012110766A Pending JP2012148164A (ja) | 2004-12-08 | 2012-05-14 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2012111453A Pending JP2012176260A (ja) | 2004-12-08 | 2012-05-15 | 血管アクセスを強化するための方法および組成物 |
JP2012256574A Pending JP2013056202A (ja) | 2004-12-08 | 2012-11-22 | 血管アクセスを強化するための方法および組成物 |
JP2012256581A Pending JP2013039431A (ja) | 2004-12-08 | 2012-11-22 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
JP2014239567A Withdrawn JP2015042682A (ja) | 2004-12-08 | 2014-11-27 | 細胞含有流動性組成物の最小侵襲投与のための材料および方法 |
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US (8) | US20080119946A1 (ja) |
EP (5) | EP1824529B1 (ja) |
JP (8) | JP2008522738A (ja) |
CN (4) | CN102772824A (ja) |
AT (2) | ATE474608T1 (ja) |
AU (4) | AU2005314263B2 (ja) |
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