JP7343091B2 - 軟骨損傷関連の疾患を処置するための、ヒアルロン酸及び幹細胞を含む医薬組成物 - Google Patents
軟骨損傷関連の疾患を処置するための、ヒアルロン酸及び幹細胞を含む医薬組成物 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/48—Reproductive organs
- A61K35/51—Umbilical cord; Umbilical cord blood; Umbilical stem cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
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Description
変形性関節症誘発ラットを生成するため、スプラーグドーリーラットに、5mg/kgの用量でZoletil 50(VIRBAC、France)及び2.5mg/kgの用量でキシラジン(ロンプン(Rompun)(登録商標))、Bayer AG、Germany)の腹腔内投与によって麻酔をかけた。次いで、クリッパーを使用して、両膝の周りの部域を剃毛した。切開されるべき部域をポビドン及び70%アルコールで消毒し、次いで、膝皮膚を切開した。周辺の皮膚組織を鈍的切開にかけることで、右大腿骨の遠位端部で関節表面を露出した。次いで、前十字靱帯を剪刀でカットし、4~0ナイロンを使用して創傷を縫合した。7日後、軟骨の破壊及び疼痛を引き起こすヨード酢酸一ナトリウム(MIA)を1mlのシリンジに充填し、50μlの量にて60mg/mlの濃度で関節内投与した。左膝については、前十字靱帯をカットすることなくMIAの投与のみを行った。
実施例2:組織病理学的検査
各群におけるラットを16週目に屠殺し、関節組織を回収した。次いで、組織を脱ミネラル化、トリミング、脱水、パラフィン包埋及びミクロトームカッティングにかけることで、組織病理学的検査のための標本を調製した。次いで、ヘマトキシリン及びエオシン(H&E)、サフラニン-O、並びに抗II型コラーゲン抗体を使用して染色を行い、光学顕微鏡(オリンパスBX53、日本)を使用して観察を行った(図1及び図2)。
実施例3:重量負荷試験
Panlabインキャパシタンス試験器を使用し、薬物投与後0週目及び16週目にプラスチック固定具をラットに60度の傾斜で直立させるようにすること、及び次いで、各群におけるラットの後肢に10秒間適用された力の平均を算出することによって、重量負荷試験を行った。薬物が注射された後肢に分布された体重の百分率を、以下の算出式を介して測定した(図3)。
結果として、薬物投与後16週目で、全ての関節炎誘発群(G2~G5)は、重量負荷の点で、G1群(p<0.001)よりも統計的に有意に低いことが示された。加えて、G4群は、G3群(p<0.05)と比較して、有意に改善された重量負荷を有していた。さらに、G5群は、G3群及びG4群(p<0.05及びp<0.001)と比較して、有意に改善された重量負荷を有していた。これらの結果から、ヒアルロン酸が最初に投与され、その後に間葉系幹細胞の投与が続いた場合において、こうした順序で行われた投与は、重量負荷によって引き起こされる疼痛を緩和し得ることが同定された(図4)。
実施例4:マイクロコンピューター断層撮影(マイクロCT)
薬物投与の前に及び16週目で屠殺の後にマイクロCTによって、膝関節における損傷部域の写真を撮った。プログラム(HP DECwindows Motif for OpenVMS、バージョン1.7)を用いて、脛骨及び大腿骨の横断面画像における構造要素及び骨密度を分析することによって、膝関節の評価を行った。
Claims (6)
- ヒアルロン酸;及び
間葉系幹細胞
を含む、軟骨損傷関連の疾患を処置するための医薬組成物であって、
医薬組成物がそれを必要とする患者に投与される場合、ヒアルロン酸が最初に投与され、その後に間葉系幹細胞の投与が続き、
前記間葉系幹細胞が、臍帯血誘導間葉系幹細胞であり、
前記医薬組成物が、関節内投与される、
医薬組成物。 - ヒアルロン酸が、0.5%(w/v)~2.0%(w/v)の濃度を有する、請求項1に記載の医薬組成物。
- 間葉系幹細胞が、1.0×105細胞/ml~1.0×108細胞/mlの量で含有される、請求項1に記載の医薬組成物。
- ヒアルロン酸が、0.5%(w/v)~2.0%(w/v)の濃度を有し、間葉系幹細胞が、1.0×105細胞/ml~1.0×108細胞/mlの量で含有される、請求項1に記載の医薬組成物。
- 軟骨損傷関連の疾患が、変形性関節症、半月板断裂、変形関節炎又は軟骨軟化症である、請求項1に記載の医薬組成物。
- 変形性関節症が起こる部位が、顎関節、肩関節、肘関節、手首関節、手指関節、脊椎関節、股関節、膝関節、足首関節又はつま先関節である、請求項5に記載の医薬組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201862680748P | 2018-06-05 | 2018-06-05 | |
US62/680,748 | 2018-06-05 | ||
PCT/KR2019/006816 WO2019235853A1 (ko) | 2018-06-05 | 2019-06-05 | 히알루론산과 줄기세포를 포함하는 연골손상 관련 질환 치료용 약학 조성물 |
Publications (2)
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JP2021526137A JP2021526137A (ja) | 2021-09-30 |
JP7343091B2 true JP7343091B2 (ja) | 2023-09-12 |
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Application Number | Title | Priority Date | Filing Date |
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JP2020564727A Active JP7343091B2 (ja) | 2018-06-05 | 2019-06-05 | 軟骨損傷関連の疾患を処置するための、ヒアルロン酸及び幹細胞を含む医薬組成物 |
JP2020564579A Active JP7480454B2 (ja) | 2018-06-05 | 2019-06-05 | 有効成分として間葉系幹細胞を含む炎症性疾患の予防又は治療のための医薬組成物 |
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JP2020564579A Active JP7480454B2 (ja) | 2018-06-05 | 2019-06-05 | 有効成分として間葉系幹細胞を含む炎症性疾患の予防又は治療のための医薬組成物 |
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Country | Link |
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US (2) | US20210228636A1 (ja) |
EP (2) | EP3804736A4 (ja) |
JP (2) | JP7343091B2 (ja) |
KR (2) | KR20210008101A (ja) |
CN (2) | CN112261943A (ja) |
AU (2) | AU2019283518A1 (ja) |
CA (2) | CA3100466A1 (ja) |
SG (2) | SG11202012124PA (ja) |
WO (2) | WO2019235854A1 (ja) |
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KR20220152137A (ko) | 2021-05-07 | 2022-11-15 | 의료법인 성광의료재단 | 골 분화능 기능강화 중간엽 줄기세포 및 이의 용도 |
CN113616675A (zh) * | 2021-08-23 | 2021-11-09 | 上海太安堂生物医学有限公司 | 含间充质干细胞的组合物及其在治疗退行性关节炎的应用 |
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- 2019-06-05 US US16/972,118 patent/US20210228636A1/en active Pending
- 2019-06-05 KR KR1020207036318A patent/KR20210008873A/ko not_active Application Discontinuation
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- 2019-06-05 US US16/972,373 patent/US20210228637A1/en active Pending
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SG11202012124PA (en) | 2021-01-28 |
KR20210008101A (ko) | 2021-01-20 |
CN112261943A (zh) | 2021-01-22 |
CN112261944A (zh) | 2021-01-22 |
AU2019283518A1 (en) | 2021-01-14 |
EP3811951A1 (en) | 2021-04-28 |
US20210228636A1 (en) | 2021-07-29 |
JP2021526137A (ja) | 2021-09-30 |
SG11202011927TA (en) | 2020-12-30 |
EP3811951A4 (en) | 2022-07-13 |
JP2021526135A (ja) | 2021-09-30 |
JP7480454B2 (ja) | 2024-05-10 |
US20210228637A1 (en) | 2021-07-29 |
EP3804736A1 (en) | 2021-04-14 |
WO2019235853A1 (ko) | 2019-12-12 |
KR20210008873A (ko) | 2021-01-25 |
EP3804736A4 (en) | 2022-03-30 |
WO2019235854A1 (ko) | 2019-12-12 |
CA3100471A1 (en) | 2019-12-12 |
AU2019283517A1 (en) | 2021-01-21 |
CA3100466A1 (en) | 2019-12-12 |
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