JP2022524955A - 細胞カプセル化デバイスおよびそれを使用する方法 - Google Patents
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Abstract
Description
本出願は、2019年3月11日に出願された米国仮出願第62/816,675号の利益を主張し、本出願は、その全体が参照によって本明細書に組み込まれる。
治療用分子を生成するための対象への細胞の移植は、外因性薬物の使用に代わる魅力的な代替手段であり得る。細胞移植のカプセル化は、例えば、宿主における移植細胞の増殖を防止し、そして移植細胞の生存能力を増加させ得る。本開示は、移植細胞の生存能力および機能性を改善することを含む、対象への細胞の移植を改善するための方法およびデバイスを提供する。
本明細書に記載されている全ての刊行物、特許、および特許出願は、各々の刊行物、特許、または特許出願が具体的および個別に、参照により組み込まれることを示すように、参照により本明細書に組み込まれる。
Claims (37)
- a)約500nm未満の平均接続直径を有する複数の細孔を含む第1のポリマー層;
b)約100μm超の平均接続直径を有する複数の細孔を含む第2のポリマー層
を含むデバイスであって、
該第1のポリマー層および該第2のポリマー層は、複数のセルを封入するための内腔を規定する、デバイス。 - 前記第1のポリマー層中に存在する前記複数の細孔が、約10nm~約200nmの平均接続直径を有する、請求項1に記載のデバイス。
- 前記第1のポリマー層中に存在する前記複数の細孔が、約180nm~約220nmの平均接続直径を有する、請求項1に記載のデバイス。
- 前記第2のポリマー層中に存在する前記複数の細孔が、約100μm~約500μmの平均接続直径を有する、請求項1~3のいずれか一項に記載のデバイス。
- 前記第2のポリマー層中に存在する前記複数の細孔が、約200μm~約400μmの平均接続直径を有する、請求項1~3のいずれか一項に記載のデバイス。
- 前記第1のポリマー層中に存在する前記複数の細孔が、約1μm~約5μmの平均細孔直径を有する、請求項1~4のいずれか一項に記載のデバイス。
- 前記第2のポリマー層中に存在する前記複数の細孔が、約500μm~約3mmの平均細孔直径を有する、請求項1~6のいずれか一項に記載のデバイス。
- 前記第2のポリマー層中に存在する前記複数の細孔が、約100μm~約1mmの平均細孔直径を有する、請求項1~7のいずれか一項に記載のデバイス。
- 前記第1のポリマー層が約10μm~約200μmの厚さを有する、請求項1~8のいずれか一項に記載のデバイス。
- 前記第1のポリマー層が約20μm~約50μmの厚さを有する、請求項1~9のいずれか一項に記載のデバイス。
- 前記第1のポリマー層が約18μm~約22μmの厚さを有する、請求項1~9のいずれか一項に記載のデバイス。
- 前記第2のポリマー層が約1mm~約5mmの厚さを有する、請求項1~10のいずれか一項に記載のデバイス。
- 前記第2のポリマー層が約400μm~約600μmの厚さを有する、請求項1~10のいずれか一項に記載のデバイス。
- 約500nm未満の平均接続直径を有する第3のポリマー層をさらに含む、請求項1~12のいずれか一項に記載のデバイス。
- 前記複数の細胞を前記デバイスの前記内腔に導入するためのポートをさらに含む、請求項1~14のいずれか一項に記載のデバイス。
- 前記第1のポリマー層、前記第2のポリマー層、前記第3のポリマー層、またはそれらの組合せが、ポリカプロラクトン(PCL)、ポリフッ化ビニリデン(PVDF)、ポリテトラフルオロエチレン(PTFE)、ポリエチレン(PE)、メタクリレートポリマー、ポリエチレンイミン、ポリエチレンイミン-デキストランスルフェート、ポリ(ビニルシロキサン)エコポリマーポリエチレンイミン、ホスホリルコリン、ポリ(エチルメタクリレート)、ポリウレタン、ポリ(エチレングリコール)(PEG)、ポリ(乳酸-グリコール酸)(PLGA)、ヒドロキシアパタイト、ポリ(乳酸)、ポリヒドロキシ吉草酸およびそのコポリマー、ポリヒドロキシ酪酸およびそのコポリマー、ポリジオキサノン、ポリ無水物、ポリシアノアクリレート、ポリ(アミノ酸)、ポリ(オルトエステル)、ポリエステル、コラーゲン、ゼラチン、セルロースポリマー、キトサン、アルギン酸塩、ラミニン、ならびにそれらの任意の組合せからなる群から選択される生体適合性ポリマーを含む、請求項1~15のいずれか一項に記載のデバイス。
- 前記生体適合性ポリマーがポリカプロラクトンである、請求項16に記載のデバイス。
- 前記複数の細胞が、甲状腺細胞、副甲状腺細胞、骨髄細胞、間葉系幹細胞、間質細胞、多能性幹細胞、誘導多能性幹細胞、胚性幹細胞、血管細胞、脂肪組織由来の細胞、骨髄由来の細胞、腸管細胞またはそれに由来する細胞、膵島または膵島細胞、セルトリ細胞、ベータ細胞、膵島細胞の前駆細胞、ベータ細胞の前駆細胞、末梢血前駆細胞、成体組織から単離された幹細胞またはその派生物、網膜前駆派生細胞、心臓前駆派生細胞、骨芽前駆細胞、神経前駆細胞、遺伝的に形質転換された細胞、およびそれらの任意の組合せからなる群から選択される、請求項1~17のいずれか一項に記載のデバイス。
- 前記第1のポリマー層および前記第2のポリマー層が、前記第1のポリマー層および前記第2のポリマー層の周辺に沿って直接密封されている、請求項1~18のいずれか一項に記載のデバイス。
- 前記デバイスが支持体もフレームも含まない、請求項1~19のいずれか一項に記載のデバイス。
- 前記第1のポリマー層、前記第2のポリマー層、またはその両方が非積層ポリマー層である、請求項1~20のいずれか一項に記載のデバイス。
- 疾患または障害を有するまたは有する疑いがある対象に、請求項1~21のいずれか一項に記載のデバイスを移植する工程を含む方法であって、前記デバイスが複数の治療用細胞を含み、それにより該疾患または障害を処置する、方法。
- 前記対象がヒトである、請求項22に記載の方法。
- 前記複数の細胞が膵島または膵島細胞である、請求項22または23に記載の方法。
- 前記対象が、糖尿病を有するまたは有する疑いがある、請求項22~24のいずれか一項に記載の方法。
- 前記複数の細胞が、同種異系細胞、異種細胞、または自己細胞である、請求項22~25のいずれか一項に記載の方法。
- 前記デバイスが、前記内腔内に封入された複数の細胞と一緒に移植される、請求項22~26のいずれか一項に記載の方法。
- 前記デバイスが、前記内腔内に封入された細胞なしで移植される、請求項22~27のいずれか一項に記載の方法。
- 前記デバイスが前記対象に一定期間移植された後、複数の細胞が前記内腔に導入される、請求項28に記載の方法。
- 前記一定期間が少なくとも1週間である、請求項29に記載の方法。
- 前記治療用分子が前記デバイスから放出されるように構成されている、請求項22~30のいずれか一項に記載の方法。
- 前記治療用分子が前記デバイスから拡散する、請求項31に記載の方法。
- 前記治療用分子がインスリンを含む、請求項31または32に記載の方法。
- 前記移植が、皮下、網、腹腔内、後腹膜、および筋肉内移植からなる群から選択される、請求項22~33のいずれか一項に記載の方法。
- 前記デバイスが、前記対象において異物反応を誘発しない、請求項22~34のいずれか一項に記載の方法。
- 前記治療用細胞が前記第2のポリマー層内に埋め込まれている、請求項22~35のいずれか一項に記載の方法。
- 前記治療用細胞が前記第2のポリマー層に付着する、請求項22~36のいずれか一項に記載の方法。
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