JP2016516047A - 成型胎盤組織組成物、ならびにその製造および使用の方法 - Google Patents
成型胎盤組織組成物、ならびにその製造および使用の方法 Download PDFInfo
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- JP2016516047A JP2016516047A JP2016502950A JP2016502950A JP2016516047A JP 2016516047 A JP2016516047 A JP 2016516047A JP 2016502950 A JP2016502950 A JP 2016502950A JP 2016502950 A JP2016502950 A JP 2016502950A JP 2016516047 A JP2016516047 A JP 2016516047A
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- tissue
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- placental tissue
- amniotic membrane
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Abstract
Description
成型脱水胎盤組成物およびその医薬組成物を本明細書に記載する。そのような組成物は、PCT出願番号第PCT/US12/24798号、ならびに米国仮出願第61/442,346号、米国仮出願第61/543,995号、および米国仮出願第61/683,700号に記載される微粉化胎盤組織成分から調製される。これらの出願の開示内容全体が、参照により明確に本明細書に組み込まれる。「微粉化された」という用語が、ミクロンおよびサブミクロンサイズの胎盤組織粒子を含むことを理解されたい。
図1は、成型脱水微粉化胎盤材料の回収、処理および調製工程の概略(100)および特定の態様を示す。各個々の工程に関するより詳細な説明および考察を以下に記載する。最初に、胎盤組織を、選択的帝王切開後に、承諾している患者から回収する(工程110)。この材料を、従来の組織保存法で保存し、検査および評価に適した処理場所または施設に輸送する(工程120)。次いで、組織層の総処理、取扱いおよび分離を行う(工程130)。次いで、許容可能な組織を汚染除去し(工程140)、脱水する(工程145)。次いで、胎盤組織成分(例えば、個々のまたは移植片としての、羊膜、中間組織層、および/または絨毛膜)を、汚染除去および脱水後に、微粉化する(工程150)。微粉化胎盤成分を所望の形状または大きさに圧力下で圧縮/成型する(工程160)。各工程について以下に詳細に説明する。
本明細書に記載の成型脱水胎盤組織組成物を生成するために使用される成分は、胎盤に由来している。胎盤供給源は異なってもよい。一態様では、ヒトおよび他の動物(限定するものではないが、ウシおよびブタなど)等の哺乳類に由来する胎盤を本明細書で使用することができる。ヒトの場合、胎盤の回収は病院で行われ、帝王切開分娩中に胎盤が回収されることが好ましい。提供者(出産間近の母親を指す)は、移植が可能な最も安全な組織を得るために設計された包括的スクリーニングプロセスを自発的に受ける。スクリーニングプロセスは、従来の血清学的検査を用いて、ヒト免疫不全ウイルス1型および2型に対する(抗HIV−1および抗HIV−2)抗体、B型肝炎ウイルスに対する(抗HBV)抗体、B型肝炎表面抗原(HBsAg)に対する抗体、C型肝炎ウイルスに対する(抗HCV)抗体、ヒトTリンパ球向性ウイルス1型および2型に対する(抗HTLV−I、抗HTLV−II)抗体、CMVおよび梅毒に対する抗体について試験する、およびヒト免疫不全ウイルス1型(HIV−1)についておよびC型肝炎ウイルス(HCV)について核酸試験をすることが好ましい。当業者には理解されるように、時間の経過または移植片の目的の使用に基づいて、より多くの試験、より少ない試験または異なる試験が望まれたり必要となったりすることがあるため、上記試験の列挙は単に例示である。
処理センターまたは実験室に到着すると直ちに、梱包が開封され、滅菌出荷袋/容器がなお密封され、かつ冷却剤の中にあるか、適切な提供者の書類が存在するか、そして、書類上の提供者番号が当該組織を含む滅菌出荷袋上の番号と一致しているかが確認される。次いで、当該組織を含む滅菌出荷袋を、さらなる処理のための準備が整うまで冷蔵庫に保管する。
組織が、さらなる処理が可能な状態になったら、胎盤組織をさらに処理するのに必要な滅菌用品を制御された環境下の中間準備地に集め、制御された環境に入れる準備を行う。一態様では、胎盤は、室温で処理される。制御された環境が製造フードである場合、滅菌用品を開封して、従来の滅菌技術を用いてフードの中に置く。制御された環境がクリーンルームである場合、滅菌用品を開封して、滅菌ドレープで覆われたカート上に置く。従来の滅菌技術を用いて、全ての作業台を1枚の滅菌ドレープで覆い、従来の滅菌技術を再度用いて、滅菌用品および処理機器を滅菌ドレープ上に置く。
胎盤組織を以下に記載する技術を使用して、化学的に汚染除去することができる。一態様では、羊膜を室温で汚染除去する。一態様では、工程130で生成された羊膜(例えば、中間組織層を含むまたは含まない)を、次の工程のために、滅菌ナルゲン広口丸形ボトルに入れることができる。一態様では、以下の手順を使用して羊膜を洗浄することができる。ナルゲン広口丸形ボトルを、無菌的に18%高張生理食塩水で満たし、密封する(あるいは、上蓋で密閉する)。次いで、この広口丸形ボトルを振盪台の上に置き、30〜90分間撹拌し、これにより、羊膜から夾雑物をさらに除去する。振盪台がクリティカルな環境(例えば、製造フード)内にない場合、ナルゲン広口丸形ボトルを制御/無菌環境に戻してから開ける。滅菌鉗子を用いるか、内容物を無菌的にデカントすることにより、羊膜を、18%高張生理食塩水を含むナルゲン広口丸形ボトルから穏やかに取り出し、空のナルゲン広口丸形ボトルの中に入れる。次いで、羊膜を含むこの空のナルゲン広口丸形ボトルを、予め混合した抗生物質溶液で無菌的に満たす。一態様では、予め混合した抗生物質溶液は、硫酸ストレプトマイシンおよび硫酸ゲンタマイシン等の抗生物質の混合物からなる。硫酸ポリミキシンBおよびバシトラシン等の他の抗生物質または現在入手可能であるか将来入手可能である同様の抗生物質も好適である。さらに、羊膜の温度を変化させないように、添加の際に抗生物質溶液が室温であることが好ましく、そうでなければ羊膜を損傷してしまう。次いで、羊膜および抗生物質を含むこの広口丸形ボトルまたは容器を密閉または閉鎖して、振盪台の上に置き、好ましくは60〜90分間撹拌する。抗生物質溶液中の羊膜のそのような振盪または撹拌により、組織から夾雑物および細菌をさらに除去する。任意に、羊膜を洗浄剤で洗浄することができる。一態様では、羊膜を0.1〜10%、0.1〜5%、0.1〜1%、または0.5%Triton−X洗浄溶液で洗浄することができる。
一態様では、上記のような胎盤組織もしくはその成分、またはそれらの任意の組み合わせを処理して組織移植片(すなわち、積層物)にし、これを、その後に微粉化する。一態様では、胎盤組織またはそれらの個々の成分を個別に脱水し、その後、単独でまたは成分の混合物として微粉化することができる。一態様では、組織(すなわち、個別の膜または移植片)を化学的脱水により脱水され、その後凍結乾燥される。一態様では、組織に存在する残留水を実質的に(すなわち、90%超、95%超、または99%超)または完全に除去するため(すなわち、組織を脱水するため)、羊膜、絨毛膜および/または中間層を極性溶媒と十分な時間および量、接触させることにより化学的脱水工程を行う。溶媒は、プロトン性であっても、非プロトン性であってもよい。本明細書において有用な極性有機溶媒の例としては、アルコール、ケトン、エーテル、アルデヒド、またはそれらの組み合わせが挙げられるが、これらに限定されない。特に、例としては、限定するものではないが、DMSO、アセトン、テトラヒドロフラン、エタノール、イソプロパノール、またはそれらの組み合わせが挙げられる。一態様では、胎盤組織を極性溶媒と室温で接触させる。付加的に工程は必要とせず、以下に述べるように、組織を凍結乾燥することができる。
上記のような胎盤組織またはその成分を個別にまたは組織移植片の形態で脱水したら、脱水した組織を微粉化する。当該技術分野で公知の機器を使用して、微粉化胎盤成分を生成することができる。例えば、Retsch Oscillating Mill MM400を使用して、本明細書に記載されている微粉化組成物を生成することができる。本微粉化組成物中の物質の粒径も、本微粉化組成物の用途に応じて異なってもよい。一態様では、本微粉化組成物は、500μm未満、400μm未満、300μm未満、200μm未満、100μm未満、50μm未満、25μm未満、20μm未満、15μm未満、10μm未満、9μm未満、8μm未満、7μm未満、6μm未満、5μm未満、4μm未満、3μm未満、2μm、もしくは2μm〜400μm、25μm〜300μm、25μm〜200μm、または25μm〜150μmの粒子を有する。一態様では、微粉化組成物は、150μm未満、100μm未満、または50μm未満の直径の粒子を有する。他の態様では、より大きな直径(例えば、150μm〜350μm)を有する粒子が望ましい。全ての場合において、粒子の直径は、その最長の軸に沿って測定している。
微粉化された、羊膜、絨毛膜、中間組織層、およびそれらの任意の組み合わせ等の脱水微粉化胎盤成分を、好ましくは非多孔性の型に圧力をかけて、型により定められた所望の形状および大きさに成形する。多孔性の型の好ましさは低いが、成型の間、水または他の溶媒を漏出させることができる場合に、多孔性の型を本発明の方法で使用できることも考えられる。成型胎盤組織移植片は、少なくとも成型胎盤組織移植片を対象へ導入するまでにその大きさおよび形状を維持するのに十分な密度および凝集性の大きさを有する。成型胎盤組織移植片の凝集性を、微粉化胎盤成分の粒径により部分的に決定する。例えば、粒径の大きな脱水微粉化胎盤成分は、粒径の小さな脱水微粉化胎盤成分と同様の密度を有する成型胎盤組織移植片を得るために、高い圧縮圧および/またはより長い圧縮時間を必要とする。言い換えると、同様の圧縮条件下で得られた成型脱水胎盤組織組成物において、粒径の大きな組成物は、粒径の小さな組成物と比較して密度が小さく、高確率で分離する。そのため、微粉化胎盤成分の粒径を最適化し、それにより、対象へ投与する際に所望の凝集性および所望の最終的な結果を得ることは、当業者の理解の範囲にある。
本明細書に記載されている成型脱水微粉化胎盤成分を含む組成物は、多数多くの医学的用途を有する。例えば、成型脱水胎盤組織組成物を、腱、軟骨、心筋、潰瘍、または病変に、皮膚を切開することなく、局所的に投与または装着することができる。
以下の実施例は、本明細書に記載され、かつ特許請求される化合物、組成物および方法の製造および評価方法に関する完全な開示および記載を当業者に提供するために示されており、純粋に例示的なものであって、本発明者らが彼らの発明であるとみなしているものの範囲を限定するものではない。数(例えば、量、温度など)に関して正確性を保証するように努めたが、若干の誤差および偏差は考慮されるべきである。特に明記しない限り、部とは重量部であり、温度は、摂氏温度または周囲温度であり、圧力は、大気圧またはその前後の圧力である。反応条件、例えば、成分濃度、所望の溶媒、溶媒混合物、温度、圧力およびその他の反応範囲ならびに本記載の方法で得られる生成物純度および収率を最適化するために使用することができる条件の数多くの変形および組み合わせが存在する。そのようなプロセス条件を最適化するために、合理的かつ日常的な実験法のみが必要とされる。
実施例1
微粉化粒子を生成するために本明細書で使用される羊膜/絨毛膜組織移植片を米国特許出願公開第2008/0046095号(この開示内容全体が本明細書に参照により組み込まれる)に記載の方法で、生成した。組織移植片(4cm×3cm)および2つの9.5mmスチール研削ボールを、50mLバイアルに入れ、その後、当該バイアルを密封した。当該バイアルをCryo−blockに入れ、当該Cryo−blockをCryo−rackに入れた。当該Cryo−rackを液体窒素を含むDewarに入れた。組織試料に、30〜60分間以下、気相式冷却を施した。Cryo−rackをDewarから取り出し、Cryo−blockを当該Cryo−rackから取り出した。当該Cryo−block Grinder(SPEX Sample Prep GenoGrinder 2010)に入れ、1,500rpmで20分間に設定した。20分が経過した後、微粉化を確実なものとするため、組織を検査した。必要であれば、十分な微粉化を確実なものとするため、さらに30〜60分間、組織をDewarに戻し、さらに20分間粉砕機に移動させてもよい。組織が十分に微粉化されたら、1セットの米国標準ASTM篩を使用して分類する。篩を355μm、300μm、250μm、150μm、および125μmの順で置いた。微粉化材料を50mLバイアルから355μm 篩に移した。微粉化粒子を完全に分離するため、各篩を個別に揺らした。微粉化粒子が篩を使用して、効果的に分離したら、355μm、300μm、250μm、150μm、および125μmの粒径を有する微粉化粒子を別のバイアルに回収した。
実施例2
片側が雌、片側が雄の三日月形状の型を、脱水胎盤組織組成物の調製に使用する。片側の雌に、実施例1で調製した10mgの微粉化された羊膜/絨毛膜粒子を詰める。片側の雄に微粒子を含有させ、この場所に置くと、型に、好適な時間、好適な圧力をかけ、型の大きさおよび形状を有する成型胎盤組織組成物を得る。
Claims (7)
- 微粉化された羊膜、絨毛膜、中間組織層、およびそれらの任意の組み合わせのうち少なくとも1つを含む、所定の大きさおよび形状の成型脱水胎盤組織組成物であって、
前記組成物は、ex vivoおよびin vivoにおいて、所定の時間その大きさおよび形状を維持するのに十分な密度および凝集性を有する組成物。 - 前記組成物の含水率は、約20%未満、約15%未満、約10%未満、または約5%未満である、請求項1に記載の組成物。
- 前記微粉化された羊膜、絨毛膜、中間組織層、およびそれらの任意の組み合わせは、粒径が、約400μm未満、約350 μm未満、または約300μm未満である、請求項1に記載の組成物。
- 前記羊膜、羊膜、絨毛膜、中間組織層、またはそれらの組み合わせのうち少なくとも1つが架橋されている、請求項1に記載の組成物。
- 創傷の治癒を促進するための方法であって、請求項1に記載の組成物を創傷部位または創傷部位の近傍に塗布する、方法。
- 胎盤組織移植片は、皮下に、真皮下に、筋肉内に、または骨膜移植の境界面に投与される、請求項5に記載の方法。
- 請求項1に記載の組成物と、任意に、薬学的に許容される賦形剤とを含む医薬組成物。
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