JP2006511246A - 殺菌された異種移植片組織 - Google Patents
殺菌された異種移植片組織 Download PDFInfo
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Abstract
Description
図1は、材料特性群の比較図であり、モジュラスは比較する目的のためにMPa×10-1で報告されている。処理済み及び未処理ブタ試験群間では、極限強さ、降伏強さ又は極限歪のパラメーターにいかなる有意な差も見出されなかった。処理済み及び非処理ブタ群の間には降伏歪とモジュラスで僅かな有意ではない差が存在した。これらの差は、処理及び貯蔵による組織の水和の結果によるものと考えられ、処理前及び処理後の材料特性における重要な差を示すものではない。ヒト同種移植片群は、比較する目的のために与えられている。ブタ群とヒト移植片との間には、極限強さ、降伏強さ又は極限歪若しくは降伏歪のパラメーターに有意な差は見出されなかった。ブタ及びヒト群の間でモジュラスの差が存在したが、この差はACL再建移植片について許容できる値内にあり、そしてこれはおそらく成熟したヒト供与者と比較して若い(生後6〜10ヶ月)ブタから採取された靱帯の対応した性質によるものと考えられる。
定義
本明細書で使用するときに、用語「異種移植片」とは、ある種の動物から別の種の動物に移される移植片をいう(ステッドマン医学大事典,ウィリアム&ウィルキンス、メリーランド州バルチモア,1995)。本明細書で使用するときに、用語「異種」とは、ある種の動物から別の種の動物に移される組織をいう(同上)。また、関節軟骨の置換は同種移植によることもできる(ある個体又は動物からその同一種の別のものになされる移植(「同種異系」),Sengupta外,(1974)J.Bone Suro.56B(1):167−177;Rodrigo外,(1978)Clin Orth.134:342−349)。異種移植片用の軟組織に関しては、当業者に周知の手順に従ってブタ腹膜又は心膜を採取して同種移植片又は異種移植片を形成させることができる。例えば、米国特許第4755593号に議論されている腹膜採取手順を参照されたい。
本発明は、ヒトへの移植用の異種移植片の慢性拒絶反応に向けられる。従って、本発明の方法に従って製造された異種移植片は、実質的に非免疫原性であると同時に、一般には相当する天然ヒト組織の機械的性質を保持する。
米国食品医薬品局(FDA)の生物製剤評価・研究センター(CBER)は、近年、組織機能又は特性を変化させない方法によって再生され、処理され、保管され又は分配される移植目的のヒト組織を規制しているが、現在のところヒト薬物、生物型製品又は医療用装置としては規制されていない。このような組織の例は、骨、皮膚、角膜、靱帯及び腱である。また、FDA(CBER)は、(a)ヒト以外の動物源からの生きた細胞、組織若しくは器官又は(b)ヒト以外の動物の生きた細胞、組織若しくは器官と生体外で接触したヒトの体液、細胞、組織若しくは器官をヒト受容者に移植し、埋め込み又は注入することを伴う任意の手順の異種移植も規制している。従って、組織バンクは、処理中の組織による感染症の汚染又は二次汚染を予防するための書面による手順を有するように義務づけられている。
原材料の制御及びウイルスの不活性化
ブタ装置のウイルス安全性を動物源プロファイルの評価及び処理方法の殺ウイルス活性の評価によって評価した。使用した組織は、特定の限られたブタ群からの生後6ヶ月の動物が起源である。動物を獣医師有資格者による生前及び死後健康調査に付し、そしてUSDA検査を受けた施設で処理する。組織識別は、最終製品以前で且つ起源の動物以後の採取された材料の追跡を可能にする。製造設備における疾患制御のためにいかなる変性生ワクチンも使用しない。採取プロセス又は製造プロセスにおける任意の点での他の動物由来の材料による二次汚染はない。処理プロセスの内の2工程(グルタルアルデヒド処理及び電子線照射、17.8kGy)の殺ウイルス活性の評価中に6ログ以上のウイルス減少値がブタパルボウイルス、インフルエンザA型、仮性狂犬病ウイルス及びレオウイルス3型について観察された。換言すれば、得られた異種移植片材料は、これら3種のウイルスが「実質的にフリー」であった。
ブタ内因性レトロウイルス(PERV)は、異種材料からの潜在的危険性として議論されている(Takefman DM,Wong S.Maudru外,「ブタ血清及びブタ因子VIIにおけるブタ内因性レトロウイルスの検出及び特徴付け」,J.Virol 75(10):4551(2001))。本発明者らは、3つの別個のアッセイに基づきPERVの危険性を評価した。
伝染性海綿状脳症
伝染性海綿状脳症(TSE)疾患群としては、ヒツジ及びヤギを冒すスクラピー、伝染性ミンク脳症、ネコ海綿状脳症、シカ及びエルク慢性消耗性疾患、並びにヒトではクールー、古典的及び異型クロイツフェルト・ヤコブ病、ゲルストマン・シュトロイスラー・シャインカー症候群及び致死性家族性不眠症が挙げられる。広く「狂牛病」と呼ばれるウシ海綿状脳症(BSE)は、ウシの中枢神経系を冒す慢性変性疾患である。また、TSEは、自家用外来反芻動物、外来のネコ及び家ネコにおいても報告されている。これらの症例のいくつかから単離された因子はウシのBSEと区別できないため、これらの種でのTSEの発生は、BSEに汚染された飼料に起因することが示唆される。
生体力学試験
プロセス開発の一部分として、本発明者らは、骨−膝蓋腱−骨同種移植片の移植前の生体力学特性を特徴付けるための試験を開始した。本発明者らは、比較生体力学評価のために臨床上適切なコントロールを移植した。ブタ膝蓋腱とヒト膝蓋腱との間の解剖学的類似性、構造的類似性及び細胞の類似性を記録し、そしてこれはヒト移植片の生体力学モデリングのための実行可能な選択物及び代替物としてのブタ膝蓋腱をサポートする(Fuss FK,「家畜ブタ(Sus scrofa domestica)の前十字靱帯の解剖学的構造及び機能:ヒト前十字靱帯との比較」,J Anat 178:11(1991年10月))。この試験の全体的な目的は、Z−Lig前十字靱帯置換装置(本発明の具体例)とヒト骨−膝蓋腱−骨構成体との内部同一比較であった。追加のコントロール群は、新鮮凍結死体移植片として処理(追加の処理は施されていない)及び採取された未加工ブタ膝蓋腱を包含した。試験群及び説明を表2に与える。
生体力学評価は、FDAが推奨する計画及び試験数を取り入れている(「研究用装置製造の申請免除の指針書及び関節内人工膝靱帯装置の市販前承認申請書のアプリケーション」(1993年2月))。1群あたり最低限8種の試料を有する3種の試験群をこの研究で使用する。これらの試験群は、Z−Lig装置、ヒト膝蓋腱同種移植片及び未処理ブタ膝蓋腱移植片を包含する。全ての試験は、凍結した状態で保存され、試験直前に解凍された新鮮凍結移植片を使用した。
試料の物理的特徴を以下の表3に示す。有効な試験条件化での破損に対して試験された試料のみをこの分析のために使用した。ミリメートルで表す平均値は、それぞれの試験群について標準偏差として報告される分散で報告している。
Claims (38)
- 次の工程:
(1)実質的に非免疫原性の異種移植片材料を得、
(2)該異種移植片材料を少なくとも1種の架橋剤で処理し、
(3)該架橋異種移植片材料を放射線処理に付すこと
を含む、ヒトへの移植用の異種移植片材料の滅菌方法。 - 異種移植片材料が、炭水化物鎖であってその炭水化物鎖の非還元末端に末端α−ガラクトシル糖を有するものを実質的に欠いている、請求項1に記載の方法。
- 実質的に非免疫原性の異種移植片がプロテオグリカンを実質的に欠いている請求項1に記載の方法。
- 実質的に非免疫原性の異種移植片材料が軟組織である請求項1に記載の方法。
- 実質的に非免疫原性の異種移植片材料が心臓弁組織である請求項1に記載の方法。
- 実質的に非免疫原性の異種移植片材料がブタのものである請求項1に記載の方法。
- 実質的に免疫原性の異種移植片材料が滅菌されている請求項1に記載の方法。
- 滅菌をエチレンオキシド及びプロピレンオキシドよりなる群から選択される1種以上の薬剤で行う請求項7に記載の方法。
- 架橋剤がアルデヒド、芳香族ジアミン、カルボジイミド及びジイソシアネートよりなる群から選択される請求項1に記載の方法。
- 少なくとも1種の架橋剤がグルタルアルデヒドである請求項1に記載の方法。
- 架橋剤が約0.01%〜約5%のグルタルアルデヒドを含有する溶液である請求項1に記載の方法。
- 架橋処理を、異種移植片材料を蒸気の形態の架橋剤にさらすことによって行う、請求項1に記載の方法。
- 放射線処理が15.8kGy〜21.3kGyの範囲の滅菌線量を含む請求項1に記載の方法。
- 放射線処理が17.8kGyの有効滅菌線量を含む請求項1に記載の方法。
- 放射線処理を電子線照射又はγ線照射によって行う請求項1に記載の方法。
- 滅菌された異種移植片材料が少なくとも10-6の滅菌保証レベルを有する請求項1に記載の方法。
- 滅菌された異種移植片がブタパルボウイルス、インフルエンザA型、仮性狂犬病ウイルス及びレオウイルス3型よりなる群から選択されるウイルスを実質的に含まない請求項1に記載の方法。
- 滅菌された異種移植片材料が伝染性海綿状脳症(TSE)因子を実質的に含まない請求項1に記載の方法。
- 滅菌された異種移植片材料が天然心臓弁と実質的に同一の機械的性質を有する請求項1に記載の方法。
- 次の工程:
(a)ヒト以外の動物から軟組織異種移植片材料を得、
(b)該異種移植片材料を水及びアルコール中で洗浄し、
(c)該異種移植片材料を細胞破壊処理に付し、
(d)該異種移植片材料をグリコシダーゼで処理して複数の第1表面炭水化物部分を除去すること
を含むヒトへの移植用の異種移植片材料の製造方法において、
(i)該グリコシダーゼ処理をグリコシダーゼ処理溶液中で行い、
(ii)該グリコシダーゼ処理中に、該グリコシダーゼ処理溶液のヘッドスペースを減圧に付して該異種移植片材料内に閉じこめられている空気を除去し、
それによって該異種移植片材料が実施的に非免疫原性であり且つ予め選択されたヒト組織と実質的に同一の機械的性質を有する、ヒトへの移植用の異種移植片材料の製造方法。 - 減圧が10〜1000milliorrの間にある請求項20に記載の方法。
- 減圧が50〜500millitorrの間にある請求項20に記載の方法。
- 減圧処理が連続的である請求項20に記載の方法。
- 減圧処理が拍動的である請求項20に記載の方法。
- グリコシダーゼがガラクトシダーゼである請求項20に記載の方法。
- ガラクトシダーゼがα−ガラクトシダーゼである請求項25に記載の方法。
- 異種移植片材料から複数のプロテオグリカンを実質的に除去する工程をさらに含む請求項20に記載の方法。
- プロテオグリカン除去工程が、異種移植片をコンドロイチナーゼABC、ヒアルロニダーゼ、コンドロイチンACIIリアーゼ、ケラタナーゼ、トリプシン及びフィブロネクチン断片よりなる群から選択される少なくとも1種のプロテオグリカン除去因子で消化することを含む、請求項27に記載の方法。
- (a)プロテオグリカン除去工程をプロテオグリカン除去処理溶液中で行い、しかも(b)該プロテオグリカン除去工程中に、該プロテオグリカン除去処理溶液のヘッドスペースを減圧に付して異種移植片材料内に閉じこめられている空気を除去する、請求項27に記載の方法。
- 異種移植片材料を少なくとも1種の架橋剤で処理する工程をさらに含む請求項20に記載の方法。
- 架橋剤がアルデヒド、芳香族ジアミン、カルボジイミド及びジイソシアネートよりなる群から選択される請求項30に記載の方法。
- 少なくとも1種の架橋剤がグルタルアルデヒドである請求項30に記載の方法。
- (a)架橋処理を架橋処理溶液中で行い、しかも(b)該架橋処理中に、該架橋処理溶液のヘッドスペースを減圧に付して異種移植片材料内に閉じこめられている空気を除去する、請求項30に記載の方法。
- 異種移植片材料を少なくとも1種の酵素で処理する工程をさらに含む請求項20に記載の方法。
- 酵素がフィシン及びトリプシンよりなる群から選択される請求項34に記載の方法。
- (a)酵素処理を酵素処理溶液中で行い、しかも(b)該酵素処理中に、該酵素処理溶液のヘッドスペースを減圧に付して異種移植片材料内に閉じこめられている空気を除去する、請求項34に記載の方法。
- 異種移植片材料を石灰化防止剤、抗血栓剤、抗生剤、成長因子及びポリエチレングリコールよりなる群から選択される1種以上の薬剤で処理する工程をさらに含む請求項20に記載の方法。
- (a)前記処理を処理溶液中で行い、しかも(b)該処理中に、該処理溶液のヘッドスペースを減圧に付して異種移植片材料内に閉じこめられている空気を除去する、請求項37に記載の方法。
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WO2003097809A2 (en) | 2003-11-27 |
AU2009200191A1 (en) | 2009-02-12 |
EP1511445B1 (en) | 2010-05-05 |
US20100196870A1 (en) | 2010-08-05 |
ATE466543T1 (de) | 2010-05-15 |
CA2525645A1 (en) | 2003-11-27 |
US20030068815A1 (en) | 2003-04-10 |
JP4535324B2 (ja) | 2010-09-01 |
DE60332456D1 (de) | 2010-06-17 |
EP1511445A4 (en) | 2006-01-25 |
EP1511445A2 (en) | 2005-03-09 |
AU2003231785A1 (en) | 2003-12-02 |
WO2003097809A3 (en) | 2004-09-16 |
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