JP2020522522A - 網膜疾患を処置するための組成物ならびにそれを作製および使用するための方法 - Google Patents
網膜疾患を処置するための組成物ならびにそれを作製および使用するための方法 Download PDFInfo
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Abstract
Description
本出願は2017年6月5日に提出された米国特許仮出願第62/515,216号の優先権を主張し、その内容は参照によりあらゆる目的のために本明細書に組み込まれる。
本明細書に記載される主題は一般に、幹細胞生物学および再生医療の分野に関する。
網膜変性とは、網膜における光受容細胞の進行性のおよび不可逆的減退および死により引き起こされる悪化または変性をいう。光受容細胞の死は失明をもたらすことがある。
網膜疾患または状態の処置に有用である、医薬として、被験体(例えば、ヒト)において使用するための製剤、製造品および/または組成物であって、製剤、製造品または組成物が、不死ではないヒト網膜前駆細胞を含有する細胞集団を含み、製剤、製造品または組成物が、約12週〜約28週の在胎齢のヒトから得られたヒト網膜組織の試料を機械的にかつ/または酵素的に消化して、細胞および細胞塊の解離した懸濁物を作製すること;異種成分不含フィブロネクチン、オルニチン、ポリリジン、またはラミニンで被覆した培養フラスコまたはプレート中の無血清培地において懸濁物を標準酸素レベルで約4〜6継代の間、培養すること;および続いて無血清培地において懸濁物を低酸素レベルでさらに約3〜6継代の間、培養することであって、細胞は、40%〜90%コンフルエンスの間で継代させ、継代ごとに酵素で処理して細胞を解離させ、新たな培養培地を添加し、それによって不死ではないヒト網膜前駆細胞を製造する、培養することによって製造され、不死ではないヒト網膜前駆細胞が、ネスチン、Sox2、Ki−67、MHCクラスI、MHCクラスII、オステオポンチン(OPN)、塩基性線維芽細胞成長因子(bFGF)、およびFas/CD95からなる群より選択される1つまたは複数のマーカーを発現し、ネスチンが、集団中の細胞の90%超によって発現され、Sox2が、集団中の細胞の80%超によって発現され、Ki−67が、集団中の細胞の30%超によって発現され、MHCクラスIが、集団中の細胞の70%超によって発現され、Fas/CD95が、集団中の細胞の30%超によって発現され、MHCクラスIIが、集団中の細胞の2%未満によって発現され、オステオポンチン(OPN)が、集団中の細胞により約20ng/106細胞/24時間よりも多い量で発現され、塩基性線維芽細胞成長因子(bFGF)が、集団中の細胞により、細胞がベースラインでbFGFを含まなかった担体中に存在する場合、約50〜約300pg/106細胞/時間の量で発現される、製剤、製造品および/または組成物が本明細書で提供される。集団中の細胞は、中脳星状細胞由来神経栄養因子(MANF)(例えば、約0.5〜約2.5ng/106細胞/24時間の量で)、色素上皮由来成長因子(PEDF)(例えば、最大約30ng/106細胞/24時間の量で)、プレイオトロフィン(PTN)(例えば、約50〜約600pg/106細胞/24時間の量で)、および/またはミッドカイン(MDK)(例えば、最大約12ng/106細胞/24時間の量で)をさらに発現してもよい。
定義
本開示の理解を促進するため、いくつかの用語は以下に定義される。本明細書の用語を使用して、本明細書に記載される主題の特定の実施形態を説明するが、その使用は、特許請求の範囲において概要が述べられる以外、主題の範囲を定めるものではない。
代わりの実施形態では、哺乳動物網膜前駆細胞の単離、特徴付け、および使用は国際公開第2012/158910号に詳細に記載されている通りであり、その特許文献は参照によりその全体を本明細書に組み込まれる。
胎児網膜細胞、例えば、ヒト網膜前駆細胞(hRPC)の解離した懸濁物を製造、単離、および/または使用するための方法も提供される。種々の実施形態では、胎児網膜細胞の懸濁物は組織もスキャフォールドも含まない。
網膜疾患に罹った患者の処置のために、細胞懸濁物として調製され同種異系移植片として使用される培養された網膜前駆細胞の方法および使用も本明細書で提供される。例えば、未成熟哺乳動物由来の培養された不均一細胞集団、例えば、ヒト網膜の使用を含むまたはそれからなる細胞ベースの療法が本明細書で提供される。
代わりの実施形態では、本明細書に記載される網膜前駆細胞および細胞集団は、経口的に、非経口的に、吸入スプレーにより、経鼻的に、局所的に、髄腔内に、髄腔内に、脳内に、硬膜外に、頭蓋内にまたは直腸に、を含む任意のまたは種々の手段による投与用の組成物として製剤化してもよい。本明細書に開示される組成物および製剤は、薬学的にまたは獣医的に許容される液体、担体、アジュバントおよびビヒクルを含有することが可能であり、液体、錠剤、カプセル、移植片、エアロゾル、ゲル、リポソーム、ナノ粒子、等の形態が可能である。
本明細書で開示される方法(例えば、網膜疾患もしくは状態を処置する、または胎児神経網膜細胞の不均一混合物を作成するもしくは単離する)のいずれかにおける使用に適した本明細書に記載される組成物(例えば、胎児神経網膜細胞の不均一混合物)のいずれかを含有し、その使用のための指示を含む、キットも提供される。細胞の組成物、製造品、または混合物もしくは培養物(例えば、胎児神経網膜細胞の不均一混合物)を含有するキットも提供され、必要に応じて、キットは本明細書に記載される方法のいずれかを実施するための指示をさらに含む。
本明細書に記載される組成物および方法のいずれでも獣医学的適用のために使用することも可能である。例えば、ネコRPCの成長、ならびにジストロフィーのネコおよび他の動物、例えば、任意の哺乳動物ペット、一般的な飼い慣らされたおよび希少野生哺乳動物種、動物園の動物、農場動物、スポーツ(例えば、レース用イヌまたはウマ)動物、等の網膜への治療適用。
胎児神経網膜細胞の不均一混合物を含有する本明細書に記載される組成物の1つまたは複数を含む移植片および人工臓器、バイオリアクター系、細胞培養系、プレート、皿、チューブ、ビンならびにフラスコ、等も提供される。
本発明の1つまたは複数の実施形態の詳細は、上の添付の記載に明らかにされている。本明細書に記載される方法および材料に類似するまたは均等であるいかなる方法および材料も本発明の実施または試験において使用することが可能であるが、好ましい方法および材料が現在記載されている。
Claims (56)
- 網膜疾患または状態の処置に有用である、医薬として、被験体において使用するための製剤、製造品または組成物であって、
前記製剤、前記製造品または前記組成物が、不死ではないヒト網膜前駆細胞を含む細胞集団を含み、
前記製剤、前記製造品または前記組成物が、
約12週〜約28週の在胎齢のヒトから得られたヒト網膜組織の試料を機械的にかつ/または酵素的に消化して、細胞および細胞塊の解離した懸濁物を作製すること、
異種成分不含フィブロネクチン、オルニチン、ポリリジン、またはラミニンで被覆した培養フラスコまたはプレート中の無血清培地において前記懸濁物を標準酸素レベルで約4〜6継代の間、培養すること、および
その後無血清培地において前記懸濁物を低酸素レベルでさらに約3〜6継代の間、培養することであって、
前記細胞は、40%〜90%コンフルエンスの間で継代させ、継代ごとに酵素で処理して前記細胞を解離させ、新たな培養培地を添加し、
それによって不死ではないヒト網膜前駆細胞を作製する、培養すること
によって作製され、
前記不死ではないヒト網膜前駆細胞が、ネスチン、Sox2、Ki−67、MHCクラスI、MHCクラスII、オステオポンチン(OPN)、塩基性線維芽細胞成長因子(bFGF)、およびFas/CD95からなる群より選択される1つまたは複数のマーカーを発現し、
ネスチンが、前記集団中の前記細胞の90%超によって発現され、
Sox2が、前記集団中の前記細胞の80%超によって発現され、
Ki−67が、前記集団中の前記細胞の30%超によって発現され、
MHCクラスIが、前記集団中の前記細胞の70%超によって発現され、
Fas/CD95が、前記集団中の前記細胞の30%超によって発現され、
MHCクラスIIが、前記集団中の前記細胞の2%未満によって発現され、
オステオポンチン(OPN)が、前記集団中の前記細胞により20ng/106細胞/24時間よりも多い量で発現され、
塩基性線維芽細胞成長因子(bFGF)が、前記細胞がベースラインでbFGFを含まなかった担体中に存在する場合、前記集団中の前記細胞により、50〜300pg/106細胞/時間の量で発現される、
製剤、製造品または組成物。 - 前記集団中の前記細胞が、
中脳星状細胞由来神経栄養因子(MANF)を0.5〜2.5ng/106細胞/24時間の量で、
色素上皮由来成長因子(PEDF)を最大30ng/106細胞/24時間の量で、
プレイオトロフィン(PTN)を50〜600pg/106細胞/24時間の量で、および/または
ミッドカイン(MDK)を最大12ng/106細胞/24時間の量で
発現する、請求項1に記載の方法。 - 前記懸濁物を低酸素レベルで培養するその後の培養に続いて、前記細胞を標準酸素レベルで継代せずにある期間、成長させる、請求項1に記載の製剤、製造品または組成物。
- 前記ある期間が1時間〜5日間を含む、請求項3に記載の製剤、製造品または組成物。
- 前記低酸素レベルが、0.5%、1%、1.5%、2%、2.5%、3%、3.5%、4%、4.5%、5%、5.5%、6%、6.5%、7%、7.5%、8%、8.5%、9%、9.5%、または10%酸素からなる群より選択される、請求項1〜3のいずれか一項に記載の使用のための製剤、製造品または組成物。
- 1〜2日ごとに交換される前記培養培地に、0.01mg/ml〜0.5mg/mlのビタミンCが含まれる、請求項1〜5のいずれか一項に記載の使用のための製剤、製造品または組成物。
- 前記被験体がヒトである、請求項1〜6のいずれか一項に記載の使用のための製剤、製造品または組成物。
- 前記製剤、前記製造品または前記組成物が、前記被験体の硝子体腔または網膜下腔中への注射用に製剤化されている、請求項1〜7のいずれか一項に記載の使用のための製剤、製造品または組成物。
- 前記網膜疾患または状態が、網膜色素変性(RP)、レーバー先天性黒内障(LCA)、シュタルガルト病、アッシャー症候群、コロイデレミア、杆体錐体または錐体杆体ジストロフィー、繊毛関連疾患、ミトコンドリア障害、進行性網膜萎縮、変性網膜疾患、加齢黄斑変性(AMD)、ウェット型AMD、ドライ型AMD、地図状萎縮、家族性または後天性黄斑症、網膜光受容体疾患、網膜色素上皮ベースの疾患、糖尿病性網膜症、類嚢胞黄斑浮腫、ぶどう膜炎、網膜剥離、外傷性網膜損傷、医原性網膜損傷、黄斑円孔、黄斑毛細血管拡張症、神経節細胞疾患、視神経細胞疾患、緑内障、視神経症、虚血性網膜疾患、未熟児網膜症、網膜血管閉塞、家族性細動脈瘤、網膜血管疾患、眼血管疾患、血管疾患、または虚血性視神経症を含む、請求項1〜8のいずれか一項に記載の使用のための製剤、製造品または組成物。
- 前記製剤、前記製造品または前記組成物中の前記細胞が、ビメンチン、CD9、CD81、AQP4、CXCR4、CD15/LeX/SSEA1、GD2ガングリオシド、CD133、β3−チューブリン、MAP2、GFAP、OPN/SPP1、PTN、KDR、およびTEKからなる群より選択される1つまたは複数のマーカーをさらに発現する、請求項1〜9のいずれか一項に記載の使用のための製剤、製造品または組成物。
- 不死ではないヒト胎児神経網膜細胞の不均一混合物を含む製剤、製造品または組成物を製造する方法であって、
(a)約12週〜約28週の在胎齢のヒトから得られたヒト網膜組織細胞の試料を機械的にかつ/または酵素的に解離させて、細胞および/または細胞塊の解離した懸濁物を作製することであって、
細胞および/または小さな細胞塊の収穫された試料は、トリプシンまたは等価物を使用して酵素的に解離される、作製すること;
(b)異種成分不含フィブロネクチン、オルニチン、ポリリジン、またはラミニンで被覆した培養フラスコまたはプレート中の無血清培地において前記懸濁物を標準酸素レベルで約4〜6継代の間、培養すること;および
(c)その後無血清培地において前記懸濁物を低酸素レベルでさらに約3〜6継代の間、培養することであって、
前記細胞は、40%〜90%コンフルエンスの間で継代させ、継代ごとに酵素で処理して前記細胞を解離させ、前記細胞培地は、約1〜2日ごとに交換される、培養すること
を含む、方法。 - 前記懸濁物を低酸素レベルで培養するその後の培養に続いて、前記細胞を標準酸素レベルで継代せずにある期間、成長させる、請求項11に記載の方法。
- 前記ある期間が1時間〜5日間を含む、請求項12に記載の方法。
- 前記低酸素レベルが、0.5%、1%、1.5%、2%、2.5%、3%、3.5%、4%、4.5%、5%、5.5%、6%、6.5%、7%、7.5%、8%、8.5%、9%、9.5%、または10%酸素からなる群より選択される、請求項11または12に記載の方法。
- 1〜2日ごとに交換される前記培養培地に、0.01mg/ml〜0.5mg/mlのビタミンCが含まれる、請求項10〜13のいずれか一項に記載の方法。
- 前記細胞および/または前記細胞塊が基本培養培地で培養される、請求項11〜15のいずれか一項に記載の方法。
- 前記細胞および/または前記細胞塊が、細胞生存または成長を支援する補足物または添加物と一緒に培養される、請求項16に記載の方法。
- 細胞生存または成長を支援する前記補足物または前記添加物が、L−グルタミン、EGFおよびbFGFからなるヒト組換え成長因子(Invitrogen)ならびに他の成長因子からなる群より選択される、請求項17に記載の方法。
- 前記培地に、アルブミン、または組換えアルブミンが約1.0mg/mlの初期濃度を有する量で追加補充される、請求項11〜18のいずれか一項に記載の方法。
- 細胞の前記試料が、病原体、細菌、エンドトキシン、真菌、マイコプラズマ、ウイルス、肝炎ウイルスまたはHIVウイルスの存在についてスクリーニングされる、請求項11〜19のいずれか一項に記載の方法。
- 細胞の前記試料が、正常核型の存在についてスクリーニングされる、請求項11〜20のいずれか一項に記載の方法。
- 細胞の前記試料が上昇したテロメラーゼ活性を示さない、請求項11〜21のいずれか一項に記載の方法。
- 細胞の前記試料が生存度についてスクリーニングされる、請求項11〜22のいずれか一項に記載の方法。
- 細胞の前記試料が腫瘍原性についてスクリーニングされる、請求項11〜23のいずれか一項に記載の方法。
- 不死ではないヒト胎児神経網膜細胞の前記不均一混合物を製造するための前記方法が、
(a)細胞表面または遺伝子マーカーに基づいてヒト胎児神経網膜細胞を選択すること、または
(b)ヒト胎児神経網膜細胞トランスクリプトームプロファイル、プロテオームプロファイルまたはゲノムプロファイルに基づいてヒト胎児神経網膜細胞を選択すること
をさらに含む、請求項11〜24のいずれか一項に記載の方法。 - (i)ステップ(a)が、前記細胞を培養前に(事前に)または培養後にまたは培養前と培養後との両方において選択することをさらに含み;
(ii)前記細胞表面または遺伝子マーカーが、CD15/LeX/SSEA1および/もしくはGD2ガングリオシドを含み;または
(iii)前記細胞表面または遺伝子マーカーが、CD9、CD81、CD133もしくはAQP4および/もしくはCXCR4を含む、請求項25に記載の方法。 - 不死ではないヒト網膜前駆細胞の集団を単離するための方法であって、
網膜が形成された後であるが、光受容体外節が網膜全体で完全に形成される前であり、網膜血管新生が実質的に完了するまたは完了する前の段階に由来するヒト網膜組織の試料を機械的にかつ/または酵素的に解離して、細胞および細胞塊の解離した懸濁物を作製すること;
異種成分不含フィブロネクチン、オルニチン、ポリリジン、またはラミニンで被覆した培養フラスコまたはプレート中の無血清培地において前記懸濁物を標準酸素レベルで約4〜6継代の間、培養すること;
その後無血清培地において前記懸濁物を低酸素レベルでさらに約3〜6継代の間、培養することであって、
前記細胞は、40%〜90%コンフルエンスの間で継代させ、継代ごとに酵素で処理して前記細胞を解離させる、培養することを含み、
前記ヒト網膜前駆細胞が、ネスチン、Sox2、Ki−67、MHCクラスI、MHCクラスII、オステオポンチン(OPN)、およびFas/CD95からなる群より選択される1つまたは複数のマーカーを発現し、ネスチンが、前記集団中の前記細胞の90%超により発現され、Sox2が、前記集団中の前記細胞の80%超により発現され、Ki−67が、前記集団中の前記細胞の30%超により発現され、MHCクラスIが、前記集団中の前記細胞の70%超により発現され、Fas/CD95が、前記集団中の前記細胞の30%超により発現され、MHCクラスIIが、前記集団中の前記細胞の2%未満により発現され、オステオポンチン(OPN)が、前記集団中の細胞により20ng/106細胞/24時間よりも多い量で発現され、塩基性線維芽細胞成長因子(bFGF)が、前記細胞がベースラインでbFGFを含まなかった担体中に存在する場合、前記集団中の細胞により、50〜300pg/106細胞/時間の量で発現される、方法。 - 前記集団中の前記細胞が、中脳星状細胞由来神経栄養因子(MANF)を0.5〜2.5ng/106細胞/24時間の量で、色素上皮由来成長因子(PEDF)を最大約30ng/106細胞/24時間の量で、プレイオトロフィン(PTN)を50〜600pg/106細胞/24時間の量で、および/またはミッドカイン(MDK)を最大12ng/106細胞/24時間の量で発現する、請求項27に記載の方法。
- 前記懸濁物を低酸素レベルで培養するその後の培養に続いて、前記細胞を標準酸素レベルで継代せずにある期間、成長させる、請求項27に記載の方法。
- 前記ある期間が1時間〜5日間を含む、請求項29に記載の方法。
- 前記低酸素レベルが、0.5%、1%、1.5%、2%、2.5%、3%、3.5%、4%、4.5%、5%、5.5%、6%、6.5%、7%、7.5%、8%、8.5%、9%、9.5%、または10%酸素からなる群より選択される、請求項27または28に記載の方法。
- 前記培養培地が1〜2日ごとに交換される、請求項27〜31のいずれか一項に記載の方法。
- 1〜2日ごとに交換される前記培養培地に、0.01mg/ml〜0.5mg/mlのビタミンCが含まれる、請求項27〜32のいずれか一項に記載の方法。
- 前記ヒト網膜組織が、約12週〜約28週の在胎齢のヒト胎児網膜から得られる、請求項27〜33のいずれか一項に記載の方法。
- 前記細胞が、無血清または低血清の細胞培養培地で培養される、請求項27〜33のいずれか一項に記載の方法。
- 前記培地がアルブミンをさらに含む、請求項27〜35のいずれか一項に記載の方法。
- 前記集団中の前記細胞が、ビメンチン、CD9、CD81、AQP4、CXCR4、CD15/LeX/SSEA1、GD2ガングリオシド、CD133、β3−チューブリン、MAP2、GFAP、OPN/SPP1、PTN、KDR、およびTEKからなる群より選択される1つまたは複数のマーカーをさらに発現する、請求項27〜36のいずれか一項に記載の方法。
- 使用するための有効量の製剤、製造品または組成物を投与することを含む、患者において網膜疾患または状態を処置する、好転させる、予防するまたはその進行を遅らせるための方法であって、
前記製剤、前記製造品または前記組成物が、不死ではないヒト網膜前駆細胞を含む細胞集団を含み、
前記製剤、前記製造品または前記組成物が、以下:
約12週〜約28週の在胎齢のヒトから得られたヒト網膜組織の試料を機械的にかつ/または酵素的に消化して、細胞および細胞塊の解離した懸濁物を作製すること;
異種成分不含フィブロネクチン、オルニチン、ポリリジン、またはラミニンで被覆した培養フラスコまたはプレート中の無血清培地において前記懸濁物を標準酸素レベルで約4〜6継代の間、培養すること;および
その後無血清培地において前記懸濁物を低酸素レベルでさらに約3〜6継代の間、培養することであって、
前記細胞は、40%〜90%コンフルエンスの間で継代させ、継代ごとに酵素で処理して前記細胞を解離させ、新たな培養培地を添加し、
それによって不死ではないヒト網膜前駆細胞を作製する、培養すること
によって作製され、
前記不死ではないヒト網膜前駆細胞が、ネスチン、Sox2、Ki−67、MHCクラスI、MHCクラスII、オステオポンチン(OPN)、およびFas/CD95からなる群より選択される1つまたは複数のマーカーを発現し、
ネスチンが、前記集団中の前記細胞の90%超により発現され、
Sox2が、前記集団中の前記細胞の80%超により発現され、
Ki−67が、前記集団中の前記細胞の30%超により発現され、
MHCクラスIが、前記集団中の前記細胞の70%超により発現され、
Fas/CD95が、前記集団中の前記細胞の30%超により発現され、
MHCクラスIIが、前記集団中の前記細胞の2%未満により発現され、
オステオポンチン(OPN)が、前記集団中の細胞により20ng/106細胞/24時間よりも多い量で発現され、
塩基性線維芽細胞成長因子(bFGF)が、前記細胞がベースラインでbFGFを含まなかった担体中に存在する場合、前記集団中の細胞により、50〜300ng/106細胞/時間の量で発現される、方法。 - 前記集団中の前記細胞が、
中脳星状細胞由来神経栄養因子(MANF)を0.5〜2.5ng/106細胞/24時間の量で、
色素上皮由来成長因子(PEDF)を最大約30ng/106細胞/24時間の量で、
プレイオトロフィン(PTN)を50〜600pg/106細胞/24時間の量で、および/または
ミッドカイン(MDK)を最大約12ng/106細胞/24時間の量で
発現する、請求項38に記載の方法。 - 前記懸濁物を低酸素レベルで培養するその後の培養に続いて、前記細胞を標準酸素レベルで継代せずにある期間、成長させる、請求項38に記載の方法。
- 前記ある期間が1時間〜5日間を含む、請求項40に記載の方法。
- 前記低酸素レベルが、0.5%、1%、1.5%、2%、2.5%、3%、3.5%、4%、4.5%、5%、5.5%、6%、6.5%、7%、7.5%、8%、8.5%、9%、9.5%、または10%酸素からなる群より選択される、請求項38〜40のいずれか一項に記載の方法。
- 1〜2日ごとに交換される前記培養培地に、0.01mg/ml〜0.5mg/mlのビタミンCが含まれる、請求項38〜42のいずれか一項に記載の方法。
- 前記患者がヒトである、請求項38〜43のいずれか一項に記載の方法。
- 前記製剤、前記製造品または前記組成物が、前記患者の硝子体腔または網膜下腔中に注射される、請求項38〜44のいずれか一項に記載の方法。
- 前記製剤、前記製造品または前記組成物が、前記硝子体腔の前部領域中に注射される、請求項45に記載の方法。
- 前記製剤、前記製造品または前記組成物が、前記硝子体腔の後部領域中に注射される、請求項41に記載の方法。
- 網膜疾患または状態が、網膜色素変性(RP)、レーバー先天性黒内障(LCA)、シュタルガルト病、アッシャー症候群、コロイデレミア、杆体錐体または錐体杆体ジストロフィー、繊毛関連疾患、ミトコンドリア障害、進行性網膜萎縮、変性網膜疾患、加齢黄斑変性(AMD)、ウェット型AMD、ドライ型AMD、地図状萎縮、家族性または後天性黄斑症、網膜光受容体疾患、網膜色素上皮ベースの疾患、糖尿病性網膜症、類嚢胞黄斑浮腫、ぶどう膜炎、網膜剥離、外傷性網膜損傷、医原性網膜損傷、黄斑円孔、黄斑毛細血管拡張症、神経節細胞疾患、視神経細胞疾患、緑内障、視神経症、虚血性網膜疾患、未熟児網膜症、網膜血管閉塞、家族性細動脈瘤、網膜血管疾患、眼血管疾患、血管疾患、または虚血性視神経症を含む、請求項38〜47のいずれか一項に記載の方法。
- 前記有効量が0.3〜0.5×106細胞である、請求項38〜48のいずれか一項に記載の方法。
- 前記有効量が0.5〜3×106細胞である、請求項38〜48のいずれか一項に記載の方法。
- 使用のための有効量の前記製剤、前記製造品または前記組成物の投与と併せた、外科的硝子体切除、中心部硝子体切除、硝子体溶解薬、またはそれらの組み合わせの使用をさらに含む、請求項38〜50のいずれか一項に記載の方法。
- 前記患者に、使用するための前記製剤、前記製造品または前記組成物の少なくとも1回の後続用量を施す、請求項38〜51のいずれか一項に記載の方法。
- 前記後続用量が前記患者の同じ眼に投与される、請求項52に記載の方法。
- 前記後続用量が前記患者の他眼に投与される、請求項52に記載の方法。
- 使用するための前記製剤、前記製造品または前記組成物の投与に続いて、前記患者において明所(昼光)視、視力、黄斑機能、視野、暗所(夜)視、またはその任意の組み合わせが改善される、請求項38〜54のいずれか一項に記載の方法。
- 使用するための前記製剤、前記製造品または前記組成物の投与により、以下:
(i)ミューラー細胞の増強された活性化;
(ii)グルタミン合成酵素の局所的発現の増加;
(iii)血管透過性の低下;
(iv)虚血の発生の低下;
(v)網膜変性におけるマクロファージ動員の増強;
(vi)網膜変性におけるbFGFの局所的発現の増加;または
(vii)カスパーゼ3の発現の減少
のうちの1つまたは複数がもたらされる、請求項38〜54のいずれか一項に記載の方法。
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CN116445409B (zh) * | 2023-06-16 | 2023-09-22 | 中国人民解放军总医院第三医学中心 | 视杆感光前体细胞的制备方法及其应用 |
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