JP5484059B2 - 脊髄核インプラント - Google Patents
脊髄核インプラント Download PDFInfo
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- JP5484059B2 JP5484059B2 JP2009530811A JP2009530811A JP5484059B2 JP 5484059 B2 JP5484059 B2 JP 5484059B2 JP 2009530811 A JP2009530811 A JP 2009530811A JP 2009530811 A JP2009530811 A JP 2009530811A JP 5484059 B2 JP5484059 B2 JP 5484059B2
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- spinal cord
- treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1875—Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K35/35—Fat tissue; Adipocytes; Stromal cells; Connective tissues
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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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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- 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
- A61K9/0085—Brain, e.g. brain implants; Spinal cord
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
- A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Description
"X"はそれぞれの出現で独立して任意のアミノ酸を表し、且つ小文字の数字は任意のアミノ酸の数を表す。好ましくは"X"は独立して天然産出アミノ酸、および特に
A、R、N、D、B、C、Q、E、Z、G、H、I、L、K、M、F、P、S、T、W、YまたはV
を表す。]
特に好ましくは、軟骨分化・保持因子はCD−RAP(軟骨由来レチノール酸感受性タンパク質)であり、MIA(メラノーマインヒビトリー活性)、OTOR(線維細胞由来タンパク質、FDP、MIA様、MIAL)および分泌タンパク質の類に属するTANGO130とも名付けられている(Bosserhoff et al., 2004;Bosserhoff and Buettner, 2003; Bosserhoff et al., 1997; WO00/12762号)。CD−RAPあるいはMIAは、軟骨様分化に非常に特異的なマーカーである130のアミノ酸のタンパク質(EP0710248号、EP1146897号、これらは参照をもってその全文が開示されたものとする)である。遺伝子発現は軟骨形成の始めから軟骨発達を通して活性化される(Dietz and Sandell, 1996;Sakano et al.,1999)。変形性関節症による軟骨損傷の場合、CD−RAPは疾患の開始に増加したレベルで発現し、そのとき強い同化効果が観察され、且つ一度疾患が悪化すると下落する(Saito et al. 2002)。
実施例1:線維輪穿刺モデル
この実施例ではCD−RAPの注入がウサギの輪状穿刺モデルにおける椎間板高さの部分的な回復に効果的である。
持続性リポソーム調剤の調製のため、750mgのホスファチジルコリンおよび250mgのコレステロールを、丸底フラスコ内の20mlのエタノール中に溶解した。該溶剤を回転蒸発器内で計量的に除去した。生成した薄い脂質膜を10mlの水中で再水和させ、室温での緩やかな攪拌によってリポソーム(脂質10%(質量/容積))を得た。ユニラメラベシクル(SUV)をおよそ100nmの直径で、次の音波処理によって調製した。300μlのSUVを250μlのCD−RAP溶液(420mM/lのArg/PO4中に3mg/ml pH7.5)と混合し、そして次に凍結乾燥させた。該タンパク質を封入している多重膜リポソーム(MLVs)を、蒸留水での溶解ケークの再構成によって、乾燥した再構成ベシクルの適用直前に生成させた。この再水和は、約1.5μmあるいはそれより大きい平均直径を有するMLVs内への約50%あるいはそれより高い取り込み効率を、取り込み剤の化学的変質なくもたらした。
この実施例は、CD−RAPを含むリポソーム配合物の数日間にわたる安定性を説明する。リポソーム配合物の安定性を以下のように測定した:
120μgのCD−RAPを上述のように300μlのリポソーム分散液中で封入した。100μlの分割量を、300μlの二段蒸留水(bidestilled water)で希釈し、そして15分間、16000rcfでの遠心分離によって分離した。封入効率を測定するため、封入されていないCD−RAPをRP−HPLCによって標準曲線を使用して定量化した。再懸濁および遠心分離工程の6回の繰り返しは、遊離のCD−RAPの増加を示さなかった。
この実施例は足場に基づいたコラーゲンあるいはヒアルロン酸中のCD−RAP固定化インプラントを説明する。
この実施例は、CD−RAPの軟骨細胞刺激および同化活性に対して特異的な細胞外マトリックス成分の製造におけるCD−RAPの効果を分析するために有用なIVD細胞の調製方法を説明する。
アルギネートビーズを、実施例5のIVD細胞を有する0.15NaCl中の60μl、1.2%のアルギネートを102mmol/Lの塩化カルシウム溶液の中に圧出することによって形成し、半固体のビーズを形成する。該ビーズを2回洗浄し、そして1mlの培地を有する12ウェルプレート内に設置する(Aota et al., 2005)。得られるアルギネートビーズを、プロテオグリカン合成およびアグリカン発現に対してCD−RAPの添加を用いて、あるいは用いないで、フィブロネクチン断片(120kDaの断片(Chemicon、Cat. No.F1904)、ヒト血漿からの70kDaのフィブロネクチンタンパク質分解性断片(Sigma、Cat. No. F0287))の影響の分析に使用できる。
この実施例は脊髄インプラントの使用を説明し、CD−RAPがIVD細胞に添加されたとき、培養の間に著しくIVD細胞のプロテオグリカン合成およびアグリカンの発現を増加することを実証する。
実施例5によって単離されたウサギのIVD細胞が90%の集密度に達したとき、細胞を6ウェルプレート内に設置してプロテオグリカン合成を調査した。細胞を5日より長い間培養した。CD−RAPのプロテオグリカン合成への影響を分析するため、培地を1%のFCSに変更し、且つBMP−2(100ng/ml)を単独あるいはCD−RAP(100ng/ml)との組み合わせで該培地に添加した。5日後、プロテオグリカン合成を細胞培地の上澄み中で、実施例7に記載されたように、ジメチルメチレンブルー(DMMB)比色分析を使用して測定した。3つの独立した実験のGAG刺激の結果を図3にまとめる。それらのデータは、CD−RAPのBMP−2で刺激されたIVD細胞への添加が、培養されたウサギのIVD細胞においてGAGの増加をみちびくことを示す。
Claims (12)
- CD−RAPである軟骨分化・保持因子を含む、脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- インプラントが、椎間板を介して注入可能あるいは移植可能であることを特徴とする、請求項1に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- 軟骨分化・保持因子が、軟骨形成モルフォゲンであることを特徴とする、請求項1あるいは2に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- 軟骨分化・保持因子が、軟骨再生に対する同化活性を有することを特徴とする、請求項1から3までのいずれか1項に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- CD−RAPである軟骨分化・保持因子が、
配列番号1によるCD−RAPの成熟配列を含む軟骨細胞タンパク質、
の群から選択されることを特徴とする、請求項1から4までのいずれか1項に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。 - インプラントあるいは配合物が、担体を含むことを特徴とする、請求項1から5までのいずれか1項に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- インプラントあるいは配合物が、徐放機構を含むことを特徴とする、請求項1から6までのいずれか1項に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- 軟骨分化・保持因子が、リポソーム中に封入されていることを特徴とする、請求項1から7までのいずれか1項に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- 脊髄核インプラントが、髄核組織あるいは細胞を含むことを特徴とする、請求項1から8までのいずれか1項に記載の脊髄障害の治療のための脊髄核インプラントあるいは配合物。
- 脊髄障害の治療のための、CD−RAPである軟骨分化・保持因子を含む剤。
- CD−RAPが請求項2から5までのいずれか1項に定義されている、請求項10に記載の脊髄障害の治療のための剤。
- 脊髄障害が、突発性の腰痛、椎間板ヘルニア、内部椎間板破壊、あるいは椎間板損傷、神経根障害、脊髄狭窄症、髄核ヘルニア由来の坐骨神経痛、坐骨神経痛、突発性脊柱側弯症あるいはミエロパシーであることを特徴とする、請求項10あるいは11の脊髄障害の治療のための剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP06021093 | 2006-10-06 | ||
EP06021093.7 | 2006-10-06 | ||
PCT/EP2007/008660 WO2008040557A1 (en) | 2006-10-06 | 2007-10-05 | A spinal nucleus pulposus implant |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2010505482A JP2010505482A (ja) | 2010-02-25 |
JP2010505482A5 JP2010505482A5 (ja) | 2010-11-25 |
JP5484059B2 true JP5484059B2 (ja) | 2014-05-07 |
Family
ID=38910893
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2009530811A Expired - Fee Related JP5484059B2 (ja) | 2006-10-06 | 2007-10-05 | 脊髄核インプラント |
JP2009530810A Expired - Fee Related JP5404402B2 (ja) | 2006-10-06 | 2007-10-05 | 医薬適用のための乾燥した再構成したベシクル形成 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2009530810A Expired - Fee Related JP5404402B2 (ja) | 2006-10-06 | 2007-10-05 | 医薬適用のための乾燥した再構成したベシクル形成 |
Country Status (17)
Country | Link |
---|---|
US (3) | US20090297580A1 (ja) |
EP (2) | EP2081551B1 (ja) |
JP (2) | JP5484059B2 (ja) |
KR (1) | KR101333279B1 (ja) |
CN (3) | CN101605534A (ja) |
CA (1) | CA2664637C (ja) |
CY (1) | CY1113934T1 (ja) |
DK (1) | DK2081551T3 (ja) |
ES (2) | ES2400162T3 (ja) |
HR (1) | HRP20130328T1 (ja) |
PL (1) | PL2081551T3 (ja) |
PT (1) | PT2081551E (ja) |
RS (1) | RS52706B (ja) |
RU (1) | RU2443412C2 (ja) |
SI (1) | SI2081551T1 (ja) |
TW (1) | TWI455731B (ja) |
WO (2) | WO2008040556A1 (ja) |
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KR102649069B1 (ko) | 2018-05-31 | 2024-03-19 | 주식회사 엑소코바이오 | 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 안면 홍조 개선용 조성물 |
JP7079984B2 (ja) | 2018-07-28 | 2022-06-03 | エクソコバイオ インコーポレイテッド | エキソソームの凍結乾燥方法 |
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CN113995852B (zh) * | 2021-11-08 | 2024-01-30 | 河北大学 | Arg-脂质体微囊、微囊包封的鱼精蛋白-siRNA复合体及其制备方法和应用 |
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