JP7330700B2 - 回旋筋腱板修復のための設計された腱移植片 - Google Patents
回旋筋腱板修復のための設計された腱移植片 Download PDFInfo
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Description
回旋筋腱板は、腱として一体化して、腕の上腕骨の頭部のまわりの被覆を形成する4つの筋肉のネットワークである。この4つの腱は、棘上筋腱、棘下筋腱、肩甲下筋腱、及び小円筋腱を含む。ヒトにおける大部分の断裂は、棘上筋腱筋及び腱に発生するが、回旋筋腱板の他の部分もまた、断裂または損傷し得る。
骨と腱との間の界面は、腱付着部と称される。腱付着部組織の目的は、骨-腱界面で、従属する腱から強固な骨へと最小体積の組織にわたって高い忠実度で負荷を伝達することである。この組織は、2つの大いに異なる組織間の移行を補助する4つの異なる帯域からなる。腱付着部の4つの帯域は、腱、非石灰化線維軟骨、石灰化線維軟骨、及び骨である。成人組織において、腱から非石灰化線維軟骨への移行は徐々である一方で、非石灰化線維軟骨と石灰化線維軟骨との間には明確な境界が存在する。この境界は、タイドマークと称され、その極度好塩基性の性質のために、ヘマトキシリン及びエオジン(H&E)染色を使用して特定され得る(Claudepierre and Voisin,Joint Bone Spine72:32,2005、Benjamin et al.,J Anat208:471,2006)。線維軟骨帯域は、II型コラーゲンならびにプロテオグリカン(アグリカン、バイグリカン、及びデコリンなど)からなる。線維軟骨内の細胞は、円形で、小窩内に対または列で配置された、軟骨細胞の表現型を有する。この型の組織に特有である分子マーカーは存在しないが、線維軟骨及び一般に腱付着部は、このタンパク質が隣接する靱帯及び骨組織に存在しないという事実のために、II型コラーゲンの存在によって一般に特徴付けられる(Waggett et al.,Matrix Biol16:457,1998)。
設計された組織構築物
キット
様々な実施形態において、BMSC単離及び拡大は、以下のように達成され得る。無菌条件下で、穿刺法及び他の技術を使用して、当該技術分野において既知であり、かつ本明細書に記載されるように、宿主の骨から骨髄が回収され得る。以前に記載された方法を修正したものを使用して、腱構築物を形成する(米国特許第8,764,828号を参照されたい)。
足場を含まない3D組織ETG-RCの移植を、ヒツジにおいて実行した。回旋筋腱板断裂修復手順における棘下筋腱の修復のための複列の縫合修復技術と組み合わせて、構築物を移植するために手術を実行した。最初に、構築物を腱に通し、野球ボール式ステッチ及び余分な縫合を使用して、構築物の末端を固定し、3つ叉末端の腱及び骨孔への通過を可能にし、その後、骨膜及び腱に固定した。この実験の対照動物は、腱移植片構築物は移植せず、縫合のみの修復であった。全ての修復を、修復していない対側の脚と比較した。6ヶ月間の回復期間の後、対照のヒツジ(図2A及び2D)ならびに外植したヒツジ(図2B及び2E)ならびに縫合のみのヒツジ(図2C及び2F)の回旋筋腱板を、X線(図2A~2C)及び肉眼形態(図2D~2F)によって撮像して、構築物の存在及び回旋筋腱板の修復を可視化した。 対側の対照側と比較して、修復した腱のX線は、ETG-RC及び縫合修復のいずれにおいても回旋筋腱板関節へのいかなる有意な分解も示さなかった。肉眼形態は、両方の手術技術が回旋筋腱板腱で組織形成をもたらしたものの、ETG-RCが正常な組織再生を示した一方で、縫合修復は瘢痕形成を示したことを示す。
移植の6ヶ月後、接線係数を測定することによって、ヒツジの対照及び移植した腱回旋筋腱板を生体力学に試験した(図3)。
移植部位の肉眼形態及び移植の組織学的評価もまた実行した。肉眼形態は、ETG-RC群及び縫合群の両方について、修復部位で結合組織の増加が存在したことを示した。対側の対照側と比較して、修復部位は、ETG-RC修復及び縫合修復の両方について、最小量の瘢痕組織で被覆されていた。対側の対照側と比較して、修復した腱は一般に、ETG-RC修復及び縫合修復の両方について、より幅広く、より長く、かつより厚かった。X線検査は、ETG-RC群及び縫合群のいずれについても、回旋筋腱板の変性の徴候を示さなかった。
Claims (18)
- 組織化した線維性組織である腱への移植後にインビボで腱付着部を確立するように構成されている、培養によって成長する細胞に由来する、天然組織内に組み込まなくてはなら ない外因的な足場がなくて人工的に作製された組織の腱構築物である回旋筋腱板修復構築物であって、
i)骨固定末端であって、前記骨固定末端が、腱修復手術において骨に固定するための腱組織の単一カラムを含み、骨固定末端の反対で、前記カラムが分岐して、前記腱構築物の腱固定末端を形成している、骨固定末端と、
ii)2つ以上の腱叉を有する腱固定末端であって、各々が腱修復手術において腱に固定するための自由末端を有し、骨固定末端で、前記2つ以上の腱叉が融合して、前記構築物の前記骨固定末端の1つの末端を形成している、腱固定末端と、を含み、
前記骨固定末端は、骨と回旋筋腱板修復構築物との界面で、腱、非石灰化線維軟骨、石 灰化線維軟骨及び骨を含む腱付着部を再生するように構成されている、回旋筋腱板修復構築物。 - 前記骨固定末端が、3~6mmの直径を有し、前記腱叉の各々の直径が、2~3mmである、請求項1に記載の回旋筋腱板修復構築物。
- 前記骨固定末端が、2~7cmの長さである、請求項1または2に記載の回旋筋腱板修復構築物。
- 前記腱叉の各々の長さが、1~5cmである、請求項1~3のいずれか1項に記載の回旋筋腱板修復構築物。
- 前記腱固定末端叉が、前記構築物全体の長さの2分の1(1/2)~3分の2(2/3)から始まる、請求項1~4のいずれか1項に記載の回旋筋腱板修復構築物。
- 前記腱固定末端が、2、3、4、または5つの叉を有する、請求項1~5のいずれか1項に記載の回旋筋腱板修復構築物。
- 回旋筋腱板修復構築物が凍結されている請求項1に記載の回旋筋腱板修復構築物。
- 骨固定末端及び腱固定末端を有する骨-腱構築物である、天然組織内に組み込まなくて はならない外因的な足場がない回旋筋腱板修復構築物を形成する方法であって、
(a)外因的な足場に髄間質細胞を配置することなく、線維形成成長培地内の基材上に前記細胞を配置し、前記細胞に集密的な腱単層を形成させることであって、三次元腱構築物が、前記基材からの前記単層の剥離を介して形成されることと、
(b)前記三次元腱構築物が、1~2mmの直径及び4~10cmの長さになるまで、前記腱構築物を培養物中で成長させることと、
(c)2つ以上の腱構築物を、線維形成分化培地中の培養物中に長さ方向に並列に配置することで、前記2つ以上の腱構築物の長さの2分の1(1/2)~3分の2(2/3)が、ともに融合して、前記修復構築物の前記骨固定末端となり、前記腱構築物の残りの1/2~1/3が、前記修復構築物の前記腱固定末端の個々の腱叉の形成のために保持されることと、を含み、
腱付着部は、骨と回旋筋腱板修復構築物との界面で、腱、非石灰化線維軟骨、石灰化線維 軟骨及び骨を含む
方法。 - 前記腱固定末端が、2、3、4、または5つの叉を有する、請求項8に記載の方法。
- 6つの単一腱構築物が、培養物中に配置され、前記骨固定末端が、6つ全ての構築物を前記構築物の長さの2分の1(1/2)~3分の2(2/3)で融合することによって形成され、前記腱固定末端が、2つの腱構築物をともに対合させて、前記構築物の前記腱固定末端の前記腱叉のうちの単一腱叉を形成することによって形成される、請求項8に記載の方法。
- 前記回旋筋腱板修復構築物が、少なくとも6週間培養物中で成長される、請求項8~1 0のいずれか1項に記載の方法。
- 少なくとも6週間の培養物中での成長後に、前記回旋筋腱板修復構築物を-80℃±5℃で凍結することを更に含む、請求項8~11のいずれか1項に記載の方法。
- 前記回旋筋腱板修復構築物の前記骨固定末端が、3~6mmの直径を有し、前記回旋筋腱板修復構築物の前記腱固定末端叉の各々の直径が、2~3mmである、請求項8~12のいずれか1項に記載の方法。
- 前記骨固定末端が、2~7cmの長さである、請求項8~13のいずれか1項に記載の方法。
- 前記腱固定末端叉の各々の長さが、1~5cmである、請求項8~14のいずれか1項に記載の方法。
- 前記腱固定末端叉が、前記構築物全体の長さの2分の1(1/2)~3分の2(2/3)から始まる、請求項8~15のいずれか1項に記載の方法。
- 前記線維形成成長培地が、塩基性線維芽細胞成長因子、デキサメタゾン、アスコルビン酸-2-ホスファターゼ、及びL-プロリンのうちの1つ以上を含む、請求項8~16のいずれか1項に記載の方法。
- 前記線維形成分化培地が、デキサメタゾン、アスコルビン酸-2-ホスファターゼ、L-プロリン、及びトランスフォーミング成長因子ベータのうちの1つ以上を含む、請求項 8~17のいずれか1項に記載の方法。
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