RU2010137106A - Композиции и способы для дистракциионного остеогенеза - Google Patents

Композиции и способы для дистракциионного остеогенеза Download PDF

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RU2010137106A
RU2010137106A RU2010137106/15A RU2010137106A RU2010137106A RU 2010137106 A RU2010137106 A RU 2010137106A RU 2010137106/15 A RU2010137106/15 A RU 2010137106/15A RU 2010137106 A RU2010137106 A RU 2010137106A RU 2010137106 A RU2010137106 A RU 2010137106A
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calcium phosphate
pdgf
solution
composition
microns
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RU2010137106/15A
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English (en)
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Чарльз Э. ХАРТ (US)
Чарльз Э. Харт
Самьюэл Э. ЛИНЧ (US)
Самьюэл Э. ЛИНЧ
Майкл Дж. ЭРЛИХ (US)
Майкл Дж. ЭРЛИХ
Дуглас К. МУР (US)
Дуглас К. МУР
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Байомайметик Терапьютикс, Инк. (Us)
Байомайметик Терапьютикс, Инк.
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Publication of RU2010137106A publication Critical patent/RU2010137106A/ru

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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
    • A61K38/1858—Platelet-derived growth factor [PDGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/12—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

1. Способ стимуляции остеогенеза в процедуре остеодистракции, где стимуляция остеогенеза предусматривает: применение эффективного количества композиции, содержащей раствор тромбоцитарного фактора роста (PDGF), который находится в биосовместимой матрице, в участке дистракции кости, ! где раствор PDGF состоит из PDGF в буфере; ! где PDGF присутствует в растворе в концентрации, которая находится в диапазоне от около 0,01 мг/мл до около 10 мг/мл; ! где биосовместимая матрица: (i) состоит из пористого фосфата кальция, (ii) состоит из коллагена и пористого фосфата кальция, (iii) состоит из аллотрансплантата, (iv) состоит из коллагена и аллотрансплантата, или (v) состоит из коллагена, ! где фосфат кальция или аллотрансплантат содержат сообщающиеся поры, и ! где фосфат кальция или аллотрансплантат состоят из частиц с размером в диапазоне от около 100 мкн до около 5000 мкн. ! 2. Способ по п.1, в котором композицию применяют в процедуре остеодистракции во время фазы дистракции. ! 3. Способ по п.1, в котором композицию применяют в процедуре остеодистракции во время фазы консолидации. ! 4. Способ по п.1, в котором композицию применяют во время фаз и дистракции и консолидации в процедуре остеодистракции. ! 5. Способ по п.1, где способ предусматривает ускорение консолидации кости после остеодистракции. ! 6. Способ по п.1, в котором композицию применяют в участке остедистракции по меньшей мере дважды. ! 7. Способ по п.1, в котором биосовместимая матрица состоит из пористого фосфата кальция. ! 8. Способ по п.7, в котором композицию можно вводить путем инъекции. ! 9. Способ по п.7, в котором фосфат кальция содержит β-ТСР. ! 10. Способ по п.7, в котором пористость фосфата каль

Claims (25)

1. Способ стимуляции остеогенеза в процедуре остеодистракции, где стимуляция остеогенеза предусматривает: применение эффективного количества композиции, содержащей раствор тромбоцитарного фактора роста (PDGF), который находится в биосовместимой матрице, в участке дистракции кости,
где раствор PDGF состоит из PDGF в буфере;
где PDGF присутствует в растворе в концентрации, которая находится в диапазоне от около 0,01 мг/мл до около 10 мг/мл;
где биосовместимая матрица: (i) состоит из пористого фосфата кальция, (ii) состоит из коллагена и пористого фосфата кальция, (iii) состоит из аллотрансплантата, (iv) состоит из коллагена и аллотрансплантата, или (v) состоит из коллагена,
где фосфат кальция или аллотрансплантат содержат сообщающиеся поры, и
где фосфат кальция или аллотрансплантат состоят из частиц с размером в диапазоне от около 100 мкн до около 5000 мкн.
2. Способ по п.1, в котором композицию применяют в процедуре остеодистракции во время фазы дистракции.
3. Способ по п.1, в котором композицию применяют в процедуре остеодистракции во время фазы консолидации.
4. Способ по п.1, в котором композицию применяют во время фаз и дистракции и консолидации в процедуре остеодистракции.
5. Способ по п.1, где способ предусматривает ускорение консолидации кости после остеодистракции.
6. Способ по п.1, в котором композицию применяют в участке остедистракции по меньшей мере дважды.
7. Способ по п.1, в котором биосовместимая матрица состоит из пористого фосфата кальция.
8. Способ по п.7, в котором композицию можно вводить путем инъекции.
9. Способ по п.7, в котором фосфат кальция содержит β-ТСР.
10. Способ по п.7, в котором пористость фосфата кальция больше чем около 40%.
11. Способ по п.7, в котором фосфат кальция состоит из частиц с размером в диапазоне от около 250 мкн до около 1000 мкн.
12. Способ по п.11, в котором фосфат кальция состоит из β-ТСР, при этом PDGF содержит PDGF-BB, где PDGF присутствует в растворе в концентрации, которая находится в диапазоне от около 0,1 мг/мл до около 1,0 мг/мл, и где пористость фосфата кальция больше чем около 40%.
13. Способ по п.7, в котором фосфат кальция состоит из частиц с размером в диапазоне от около 1000 мкн до около 3000 мкн.
14. Способ по п.13, в котором фосфат кальция состоит из β-ТСР, при этом PDGF содержит PDGF-BB, где PDGF присутствует в растворе в концентрации, которая находится в диапазоне от около 0,1 мг/мл до около 1,0 мг/мл, и где пористость фосфата кальция больше чем около 40%.
15. Способ по п.7, в котором фосфат кальция состоит из частиц с размером в диапазоне от около 100 мкн до около 300 мкн.
16. Способ по п.15, в котором фосфат кальция состоит из β-TCP, при этом PDGF содержит PDGF-BB, где PDGF присутствует в растворе в концентрации, которая находится в диапазоне от около 0,1 мг/мл до около 1,0 мг/мл, и где пористость фосфата кальция больше чем около 40%.
17. Способ по п.7, в котором биосовместимая матрица способна к биорезорбции таким образом, что по меньшей мере около 80% фосфата кальция подвергается резорбции в течение около одного года после имплантации.
18. Способ по п.7, в котором фосфат кальция способен абсорбировать такое количество раствора PDGF, которое равно по меньшей мере около 25% веса фосфата кальция.
19. Способ по п.7, в котором PDGF присутствует в растворе в концентрации от около 0,1 мг/мл до около 1,0 мг/мл.
20. Способ по п.19, в котором PDGF присутствует в растворе в концентрации около 0,3 мг/мл.
21. Способ по п.7, в котором буфер представляет собой ацетат натрия.
22. Способ по п.7, в котором фосфат кальция имеет пористость, которая облегчает миграцию клеток в композицию.
23. Способ по п.1, в котором биосовместимая матрица состоит из пористого фосфата кальция и коллагена.
24. Способ по п.23, в котором биосовместимая матрица состоит из коллагена и β-ТСР в соотношении около 20:80.
25. Способ по п.23, в котором фосфат кальция содержит β-ТСР.
RU2010137106/15A 2008-02-07 2009-02-09 Композиции и способы для дистракциионного остеогенеза RU2010137106A (ru)

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US2693408P 2008-02-07 2008-02-07
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US (2) US7943573B2 (ru)
EP (1) EP2259807B1 (ru)
JP (3) JP5864106B2 (ru)
CN (2) CN105854074B (ru)
AU (1) AU2009212151C1 (ru)
CA (1) CA2715254A1 (ru)
ES (1) ES2422259T3 (ru)
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