JP2021500092A - 流動性無細胞組織マトリックス製品および製造方法 - Google Patents
流動性無細胞組織マトリックス製品および製造方法 Download PDFInfo
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Abstract
Description
本発明に従って、様々なヒアルロン酸系材料を脂肪組織マトリックス粒子と混合して、以下の表1に記載の様々な組織製品組成物を生成することができる。なお、本明細書に記載のヒアルロン酸系材料は単なる例示に過ぎず、他のヒアルロン酸系材料を脂肪組織マトリックス粒子と混合できることを理解されたい。さらに、表1に示す組成物は例示に過ぎず、本発明に従って他の配合の組織製品組成物を形成することも可能である。
純粋な無細胞組織マトリックスシートおよび/または粒子と比較して、組織製品組成物の特性が本発明に従って如何に形成されたのかを判断するために、組織製品組成物の特性を測定するための様々な試験を行った。実施したそのような試験の一つは、ヒアルロン酸系材料を含む流動性担体と無細胞組織マトリックス粒子とを含む組織製品組成物の様々な例示的な実施形態の開始温度を測定する示差走査熱量測定(DSC)であった。DSC分析から、流動性担体および無細胞組織マトリックス粒子を含む試験済みの組織製品組成物は、無細胞真皮マトリックスのシートの開始温度(56℃〜58℃)と同様の55℃〜60℃の範囲の開始温度を持つことが分かった。
ここで、図7〜図15を参照すると、様々な顕微鏡画像が示され、様々な組織製品組成物の全体的な構造および分布が例示されている。
流動性担体としてヒアルロン酸(HA)を使用する開示の組織製品組成物は、宿主真皮組織における生体内インプラントとして使用される場合に、特定の利点を有する。
具体的に図19に示すように、移植した無細胞組織マトリックスの体積保持を試験した。組織移植のために、500μLの無細胞組織マトリックス粒子(固形分15%)をラットの背部に皮下注射した。外植は、移植の4週間後、12週間後または24週間後に行った。4週間の外植については、10匹のラットをそれぞれ4つの試験アームで試験した。12週間および24週間の外植では、各グループに5匹のラットを試験し、各ラットに4つの試験アームを使用した。外植片を採取して、重みを加えた。図19に示すように、移植した無細胞組織マトリックスは、移植後少なくとも24週間、元の体積(点線)の少なくとも90%を良好に保持した。
本発明に従って提供される例示的な一実施形態では、ヒアルロン酸系材料を含む流動性担体と、担体内で混合された無細胞組織マトリックス粒子とを含む組織製品組成物を、シリンジに装填して、注入デバイスを形成することができる。いくつかの例示的な実施形態では、組織製品組成物を、前述した組織製品組成物の何れかとすることができる。シリンジは、一般に、容積を規定するリザーバと、リザーバに流体的に結合された針とを含む。組織製品組成物は、リザーバ内に保持され、いくつかの例示的な実施形態では、リザーバの容積を完全に満たすことができ、その容積は、0.5mL〜5mLなど、任意の所望の容積とすることができる。特定の手順では、200mLなど、非常に大きな容量のリザーバを使用することができる。針の内径は、実行される注入部位と手順に基づいて、必要に応じて選択することができる。いくつかの例示的な実施形態では、針が、18ゲージ針、19ゲージ針、20ゲージ針、21ゲージ針またはより高いゲージ(より小さい内径)の針である。注入デバイスは、組織製品組成物で事前に満たされていてもよく、あるいは注入される前は保存されていてもよい。
Claims (44)
- 組織製品組成物であって、
ヒアルロン酸系材料を含む流動性担体と、
担体内で混合された複数の無細胞組織マトリックス粒子とを含むことを特徴とする組織製品組成物。 - 請求項1に記載の組成物において、
ヒアルロン酸系材料が架橋ヒアルロン酸であることを特徴する組成物。 - 請求項1に記載の組成物において、
ヒアルロン酸系材料が非架橋ヒアルロン酸であることを特徴する組成物。 - 請求項1に記載の組成物において、
担体が、混合前に約20mg/mLのヒアルロン酸濃度を有することを特徴する組成物。 - 請求項1に記載の組成物において、
組織マトリックス粒子が真皮マトリックスに由来することを特徴する組成物。 - 請求項5に記載の組成物において、
組織マトリックス粒子が真皮マトリックスおよび脂肪マトリックスに由来することを特徴する組成物。 - 請求項1に記載の組成物において、
組成物が、組織マトリックス粒子と担体との比率を規定し、その比率が、1〜9の間:19〜1の間の範囲にあることを特徴する組成物。 - 請求項7に記載の組成物において、
前記比率が19:1であることを特徴する組成物。 - 請求項7に記載の組成物において、
前記比率が9:1であることを特徴する組成物。 - 請求項7に記載の組成物において、
前記比率が7:3であることを特徴する組成物。 - 請求項7に記載の組成物において、
前記比率が5:5であることを特徴する組成物。 - 請求項7に記載の組成物において、
前記比率が4:6であることを特徴する組成物。 - 請求項7に記載の組成物において、
前記比率が1:9であることを特徴する組成物。 - 請求項1に記載の組成物において、
担体および組織マトリックス粒子が混合されて、約1.5%〜約14.25%の固形分を有するスラリーを形成することを特徴する組成物。 - 請求項14に記載の組成物において、
スラリーが、5Hzで、600Pa未満のG”値を有することを特徴する組成物。 - 請求項15に記載の組成物において、
5HzでのG”値が、500Pa未満であることを特徴する組成物。 - 請求項1乃至16の何れか一項に記載の組成物において、
担体および組織マトリックス粒子と混合された複数の種細胞をさらに含むことを特徴する組成物。 - 注入デバイスであって、
容積を規定するリザーバと、前記リザーバに流体的に結合された針とを含むシリンジと、
前記リザーバ内に保持された組織製品組成物とを備え、
前記組織製品組成物が、
ヒアルロン酸系材料を含む流動性担体と、
担体内で混合された複数の無細胞組織マトリックス粒子とを含むことを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
ヒアルロン酸系材料が架橋ヒアルロン酸であることを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
ヒアルロン酸系材料が非架橋ヒアルロン酸であることを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
担体が、混合前に約20mg/mLの濃度を有することを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
組織マトリックス粒子が真皮マトリックスに由来することを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
組織マトリックス粒子が複数の源に由来することを特徴する注入デバイス。 - 請求項23に記載の注入デバイスにおいて、
組織マトリックス粒子が、真皮マトリックスおよび脂肪マトリックスに由来することを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
組成物が、組織マトリックス粒子と担体との比率を規定し、その比率が、1〜9の間:19〜1の間の範囲にあることを特徴する注入デバイス。 - 請求項25に記載の注入デバイスにおいて、
前記比率が19:1であることを特徴する注入デバイス。 - 請求項25に記載の注入デバイスにおいて、
前記比率が9:1であることを特徴する注入デバイス。 - 請求項25に記載の注入デバイスにおいて、
前記比率が7:3であることを特徴する注入デバイス。 - 請求項25に記載の注入デバイスにおいて、
前記比率が4:6であることを特徴する注入デバイス。 - 請求項25に記載の注入デバイスにおいて、
前記比率が5:5であることを特徴する注入デバイス。 - 請求項25に記載の注入デバイスにおいて、
前記比率が1:9であることを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
担体および組織マトリックス粒子が混合されて、約1.5%〜約14.25%の固形分を有するスラリーを形成することを特徴する注入デバイス。 - 請求項32に記載の注入デバイスにおいて、
スラリーが、5Hzで、600Pa未満のG”値を有することを特徴する注入デバイス。 - 請求項33に記載の注入デバイスにおいて、
5HzでのG”値が、500Pa未満であることを特徴する注入デバイス。 - 請求項18に記載の注入デバイスにおいて、
前記リザーバが組織製品組成物で完全に満たされていることを特徴する注入デバイス。 - 請求項35に記載の注入デバイスにおいて、
前記リザーバの容積が0.5mL〜200mLであることを特徴する注入デバイス。 - 組織製品組成物の製造方法であって、
ヒアルロン酸系材料を含む流動性担体内で、複数の無細胞組織マトリックス粒子を混合するステップを含むことを特徴とする方法。 - 請求項37に記載の方法において、
粒子サイズにより組織マトリックス粒子を選別するステップをさらに含むことを特徴する方法。 - 請求項38に記載の方法において、
選別が、組織マトリックス粒子を少なくとも1つの篩にかけて濾過することを含むことを特徴する方法。 - 請求項39に記載の方法において、
選別が、第1の篩径を規定する第1の篩と、第1の篩径とは異なる第2の篩径を規定する第2の篩とにかけて組織マトリックス粒子を濾過することを含むことを特徴する方法。 - 請求項38に記載の方法において、
選別した組織マトリックス粒子の第1の混合物と、選別した組織マトリックス粒子の第2の混合物とを混合するステップをさらに含み、選別した組織マトリックス粒子の第1の混合物が、第1の平均粒子サイズを規定し、選別した組織マトリックス粒子の第2の混合物が、第1の平均粒子サイズとは異なる第2の平均粒子サイズを規定することを特徴する方法。 - 請求項38に記載の方法において、
選別が、混合の前に行われることを特徴する方法。 - 患者を治療する方法であって、
組織製品組成物を患者の体内に注入するステップを含み、
前記組織製品組成物が、
ヒアルロン酸系材料を含む流動性担体と、
担体内で混合された複数の無細胞組織マトリックス粒子とを含むことを特徴とする方法。 - 請求項43に記載の方法において、
前記組織製品組成物が患者の皮膚内に注入されることを特徴する方法。
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CA3142151A1 (en) | 2019-05-30 | 2020-12-03 | Lifecell Corporation | Biologic breast implant |
WO2020247793A1 (en) | 2019-06-07 | 2020-12-10 | Lifecell Corporation | Injectable mesh |
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2018
- 2018-10-19 ES ES18800396T patent/ES2960617T3/es active Active
- 2018-10-19 EP EP23184697.3A patent/EP4309686A3/en active Pending
- 2018-10-19 US US16/164,975 patent/US11826488B2/en active Active
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- 2018-10-19 AU AU2018351314A patent/AU2018351314A1/en not_active Abandoned
- 2018-10-19 JP JP2020514969A patent/JP7463273B2/ja active Active
- 2018-10-19 CN CN201880067631.1A patent/CN111225690A/zh active Pending
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- 2018-10-19 WO PCT/US2018/056630 patent/WO2019079672A1/en unknown
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AU2024205015A1 (en) | 2024-08-08 |
CN111225690A (zh) | 2020-06-02 |
EP4309686A2 (en) | 2024-01-24 |
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ES2960617T3 (es) | 2024-03-05 |
JP7463273B2 (ja) | 2024-04-08 |
JP2024096720A (ja) | 2024-07-17 |
US11826488B2 (en) | 2023-11-28 |
WO2019079672A1 (en) | 2019-04-25 |
EP3697462A1 (en) | 2020-08-26 |
US20240226375A1 (en) | 2024-07-11 |
US20190117833A1 (en) | 2019-04-25 |
AU2018351314A1 (en) | 2020-03-19 |
EP4309686A3 (en) | 2024-02-07 |
CA3075106A1 (en) | 2019-04-25 |
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