JP2021523103A - Il−33を含有するマトリックス結合型小胞(mbvs)およびそれらの使用 - Google Patents
Il−33を含有するマトリックス結合型小胞(mbvs)およびそれらの使用 Download PDFInfo
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Abstract
Description
本出願は、その全体が参照により本明細書に組み込まれる、3018年5月3日出願の米国仮出願第62/666,624号の利益を主張するものである。
政府支援に関する記載
添付の配列表に列挙されている核酸配列およびアミノ酸配列は、37C.F.R.1.822において定義されている通り、ヌクレオチド塩基については標準の文字略語、およびアミノ酸については3文字コードを使用して示されている。各核酸配列の一方の鎖のみが示されているが、示されている鎖へのいずれの言及にも相補鎖が含まれると理解されたい。配列表はASCIIテキストファイル[7123−100723−02sequencelisting.txt、2019年5月2日、4.0kb]として提出され、参照により本明細書に組み込まれる。添付の配列表中:
配列番号1〜3はmiRNA配列である。
用語
(1)心臓の肥大および心室の一方または両方の収縮機能障害を特徴とする症候群である拡張型心筋症;
(2)(a)心室壁もしくは心室中隔のいずれかの厚さの全体的もしくは限局的な増加、または(b)例えば、遺伝子疾患、高血圧症、もしくは心臓弁機能不全において起こり得る心室壁もしくは心室中隔のいずれかの厚さの全体的もしくは限局的な増加のしやすさの増加と本明細書で定義される肥大型心筋症;または
(3)優性の臨床的特色が通常心臓の弛緩能力の機能障害(拡張機能不全)であり、多くの場合、心臓筋肉へのアミロイド線維、鉄、または糖脂質などの外来物質の浸潤を特徴とする疾患の群である拘束型心筋症および浸潤性心筋症。
細胞外マトリックス(ECM)に由来するナノ小胞
MBVのECMからの単離
対象を処置するための方法
筋芽細胞分化を増大させるための方法
例示的な実施形態
a)肥大型心筋症、サルコイドーシス、慢性腎不全、中毒性心筋症、虚血再灌流傷害、急性臓器拒絶、慢性臓器拒絶、老化、慢性高血圧症、非虚血性拡張型心筋症(non−ischemic delated cardiomyopathy)、不整脈、アテローム性動脈硬化症、HIV関連慢性血管疾患、および肺高血圧症;または
b)心筋梗塞もしくは心筋虚血
によって引き起こされる、条項16に記載の方法。
a)肥大型心筋症、サルコイドーシス、慢性腎不全、中毒性心筋症、虚血再灌流傷害、急性臓器拒絶、慢性臓器拒絶、老化、慢性高血圧症、非虚血性拡張型心筋症、不整脈、アテローム性動脈硬化症、HIV関連慢性血管疾患、および肺高血圧症;または
b)心筋梗塞もしくは心筋虚血
によって引き起こされる、条項32に記載の方法。
a)肥大型心筋症、サルコイドーシス、慢性腎不全、中毒性心筋症、虚血再灌流傷害、急性臓器拒絶、慢性臓器拒絶、老化、慢性高血圧症、非虚血性拡張型心筋症、不整脈、アテローム性動脈硬化症、HIV関連慢性血管疾患、および肺高血圧症;または
b)心筋梗塞もしくは心筋虚血
によって引き起こされる、条項82に記載の組成物。
筋芽細胞に細胞外マトリックス由来の単離されたナノ小胞の有効量を接触させるステップであって、ナノ小胞が、インターロイキン(IL)−33を含有し、リシルオキシダーゼを含み、ナノ小胞が、a)CD63もCD81も発現しないか、またはb)CD63loCD81loである、ステップを含み、
それにより、筋芽細胞分化を増大させる方法。
(実施例1)
ECM生体足場から単離されたマトリックス結合型ナノ小胞は全長IL−33を含有する
(実施例2)
IL−33はMBVの内腔内に貯蔵され、タンパク質分解から保護される
(実施例3)
IL33+MBVはリモデリング促進性マクロファージ表現型を非標準ST2非依存性経路によって活性化する
(実施例4)
マクロファージ分泌物への曝露後の骨格筋前駆細胞の筋形成の評価
(図5A、B)。
(実施例5)
実施例1〜4の材料および方法
(実施例6)
移植片拒絶におけるIL−33およびMBV
(実施例7)
IL−33が存在しないと慢性拒絶が増加する
(実施例8)
IL−33+MBVは移植後の炎症性骨髄細胞の生成を制御する
(実施例9)
実施例7〜8の材料および方法
(実施例10)
線維症の処置
Claims (37)
- 障害を有するまたは有するリスクがある対象における前記障害を処置または阻害するための方法であって、
前記障害を有するまたは有するリスクがある対象を選択するステップと、
前記対象に、細胞外マトリックス由来の単離されたナノ小胞の治療有効量を投与するステップであって、前記ナノ小胞がインターロイキン(IL)−33を含有し、リシルオキシダーゼを含み、前記ナノ小胞が、a)CD63もCD81も発現しないか、またはb)CD63loCD81loである、ステップと
を含み、
それにより、前記対象における前記障害が処置または阻害され、前記障害が、a)臓器もしくは組織の線維症;b)実質臓器移植片拒絶;またはc)心筋梗塞でも心筋虚血でもない心疾患である、方法。 - 前記細胞外マトリックスが、哺乳動物細胞外マトリックスである、請求項1に記載の方法。
- 前記哺乳動物細胞外マトリックスが、ヒト細胞外マトリックスである、請求項2に記載の方法。
- 前記細胞外マトリックスが、食道組織、膀胱、小腸粘膜下組織、真皮、臍帯、心膜、心臓組織、または骨格筋に由来する、請求項1から3までのいずれか一項に記載の方法。
- 前記ナノ小胞が、miR−145および/またはmiR−181を含む、請求項1から4までのいずれか一項に記載の方法。
- 前記障害が、前記実質臓器移植片拒絶であり、前記対象が、移植された実質臓器のレシピエントである、請求項1から5までのいずれか一項に記載の方法。
- 前記ナノ小胞が、前記移植された実質臓器に投与される、請求項6に記載の方法。
- 前記移植された実質臓器が心臓である、請求項7に記載の方法。
- 前記障害が心疾患である、請求項1から5までのいずれか一項に記載の方法。
- 前記心疾患が、心不全または心虚血である、請求項1から5までのいずれか一項に記載の方法。
- 前記心疾患が、急性冠状動脈症候群、慢性安定狭心症、不安定狭心症、血管形成術、一過性脳虚血発作、虚血性再灌流傷害、跛行、血管閉塞、動脈硬化症、心不全、慢性心不全、急性非代償性心不全、心肥大、心臓線維症、大動脈弁疾患、大動脈弁または僧帽弁狭窄症、心筋症、心房細動、心不整脈、および心膜疾患を含む、請求項1から5までのいずれかに記載の方法。
- 前記ナノ小胞が、静脈内に投与される、請求項1から11までのいずれか一項に記載の方法。
- 前記障害が、臓器または組織の線維症である、請求項1から5までのいずれか一項に記載の方法。
- 前記線維症が、肝硬変、肺線維症、心臓線維症、縦隔線維症、関節線維症、骨髄線維症、腎性全身性線維症、ケロイド線維症、強皮症線維症、腎線維症、リンパ組織線維症、動脈線維症、毛細血管線維症、血管線維症、または膵線維症である、請求項13に記載の方法。
- 前記線維症が、肺線維症である、請求項14に記載の方法。
- 前記線維症が、心臓線維症である、請求項14に記載の方法。
- 前記心臓線維症が、
a)肥大型心筋症、サルコイドーシス、慢性腎不全、中毒性心筋症、虚血再灌流傷害、急性臓器拒絶、慢性臓器拒絶、老化、慢性高血圧症、非虚血性拡張型心筋症、不整脈、アテローム性動脈硬化症、HIV関連慢性血管疾患、および肺高血圧症;または
b)心筋梗塞もしくは心筋虚血
によって引き起こされる、請求項16に記載の方法。 - 前記ナノ小胞が、前記患者に吸入によって投与される、請求項15に記載の方法。
- 前記ナノ小胞が、前記対象に毎週、月2回、または毎月投与される、請求項1から16までのいずれか一項に記載の方法。
- 前記対象に追加的な治療剤の治療有効量を投与するステップをさらに含む、請求項1から19までのいずれか一項に記載の方法。
- 前記追加的な治療剤が、免疫抑制剤である、請求項20に記載の方法。
- 前記免疫抑制剤が、カルシニューリン阻害剤、抗増殖剤、mTOR阻害剤、および/またはステロイドである、請求項21に記載の方法。
- 前記カルシニューリン阻害剤が、タクロリムスまたはシクロスポリンであり、前記抗増殖剤が、ミコフェノール酸であり、前記mTOR阻害剤が、シロリムスであり、および/または前記ステロイドが、プレドニゾン、ヒドロコルチゾン、またはコルチゾンである、請求項22に記載の方法。
- 前記対象がヒトである、請求項1から23までのいずれか一項に記載の方法。
- 対象における障害の処置または阻害に使用するための組成物であって、細胞外マトリックス由来の単離されたナノ小胞の治療有効量を含み、前記ナノ小胞が、インターロイキン(IL)−33を含有し、リシルオキシダーゼを含み、前記ナノ小胞が、a)CD63もCD81も発現しないか、またはb)CD63loCD81loであり、前記障害が、a)臓器もしくは組織の線維症;b)実質臓器移植片拒絶;またはc)心筋梗塞ではない心疾患である、組成物。
- 追加的な治療剤をさらに含む、請求項25に記載の組成物。
- 前記追加的な治療剤が、免疫抑制剤である、請求項26に記載の組成物。
- 前記免疫抑制剤が、カルシニューリン阻害剤、抗増殖剤、mTOR阻害剤、および/またはステロイドである、請求項27に記載の組成物。
- 前記カルシニューリン阻害剤が、タクロリムスまたはシクロスポリンであり、前記抗増殖剤が、ミコフェノール酸であり、前記mTOR阻害剤が、シロリムスであり、および/または前記ステロイドが、プレドニゾン、ヒドロコルチゾン、またはコルチゾンである、請求項22に記載の組成物。
- 筋芽細胞分化を増大させるための方法であって、
筋芽細胞に細胞外マトリックス由来の単離されたナノ小胞の有効量を接触させるステップであって、前記ナノ小胞が、インターロイキン(IL)−33を含有し、リシルオキシダーゼを含み、前記ナノ小胞が、a)CD63もCD81も発現しないか、またはb)CD63loCD81loである、ステップを含み、
それにより、筋芽細胞分化を増大させる、方法。 - 前記筋芽細胞が、in vitroにある、請求項30に記載の方法。
- 前記細胞外マトリックスが、哺乳動物細胞外マトリックスである、請求項30または請求項31に記載の方法。
- 前記哺乳動物細胞外マトリックスが、ヒト細胞外マトリックスである、請求項32に記載の方法。
- 前記細胞外マトリックスが、食道組織、膀胱、小腸粘膜下組織、真皮、臍帯、心膜、心臓組織、または骨格筋に由来する、請求項30から33までのいずれか一項に記載の方法。
- 前記ナノ小胞が、miR−145および/またはmiR−181を含む、請求項30から34までのいずれか一項に記載の方法。
- 前記筋芽細胞が、哺乳動物対象内にある、請求項30から35までのいずれか一項に記載の方法。
- 前記哺乳動物対象がヒトである、請求項36に記載の方法。
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US11213545B2 (en) | 2017-03-02 | 2022-01-04 | University of Pittsburgh—of the Commonwealth System of Higher Education | ECM hydrogel for treating esophageal inflammation |
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