WO1999020288A1 - Precipitation d'un concentre de fibrinogene enrichi d'un facteur de croissance obtenue a partir d'un plasma enrichi aux plaquettes - Google Patents

Precipitation d'un concentre de fibrinogene enrichi d'un facteur de croissance obtenue a partir d'un plasma enrichi aux plaquettes Download PDF

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Publication number
WO1999020288A1
WO1999020288A1 PCT/US1998/021626 US9821626W WO9920288A1 WO 1999020288 A1 WO1999020288 A1 WO 1999020288A1 US 9821626 W US9821626 W US 9821626W WO 9920288 A1 WO9920288 A1 WO 9920288A1
Authority
WO
WIPO (PCT)
Prior art keywords
platelet rich
rich plasma
fibrinogen
plasma
precipitating agent
Prior art date
Application number
PCT/US1998/021626
Other languages
English (en)
Inventor
Lou Blasetti
Original Assignee
Harvest Technologies Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Harvest Technologies Corporation filed Critical Harvest Technologies Corporation
Priority to JP2000516685A priority Critical patent/JP2001520198A/ja
Priority to CA002306629A priority patent/CA2306629A1/fr
Priority to EP98953467A priority patent/EP1023078A4/fr
Publication of WO1999020288A1 publication Critical patent/WO1999020288A1/fr
Priority to US11/492,907 priority patent/US20060261014A1/en

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5094—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for blood cell populations
    • 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
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/363—Fibrinogen
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0028—Polypeptides; Proteins; Degradation products thereof
    • A61L26/0042—Fibrin; Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D17/00—Separation of liquids, not provided for elsewhere, e.g. by thermal diffusion
    • B01D17/02—Separation of non-miscible liquids
    • B01D17/0217—Separation of non-miscible liquids by centrifugal force
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D17/00—Separation of liquids, not provided for elsewhere, e.g. by thermal diffusion
    • B01D17/02—Separation of non-miscible liquids
    • B01D17/04—Breaking emulsions
    • B01D17/047—Breaking emulsions with separation aids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D21/00—Separation of suspended solid particles from liquids by sedimentation
    • B01D21/01—Separation of suspended solid particles from liquids by sedimentation using flocculating agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D21/00—Separation of suspended solid particles from liquids by sedimentation
    • B01D21/26—Separation of sediment aided by centrifugal force or centripetal force
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D21/00—Separation of suspended solid particles from liquids by sedimentation
    • B01D21/26—Separation of sediment aided by centrifugal force or centripetal force
    • B01D21/262—Separation of sediment aided by centrifugal force or centripetal force by using a centrifuge
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D21/00—Separation of suspended solid particles from liquids by sedimentation
    • B01D21/30—Control equipment
    • B01D21/34—Controlling the feed distribution; Controlling the liquid level ; Control of process parameters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2221/00—Applications of separation devices
    • B01D2221/10—Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues

Definitions

  • This application relates to improved processes for recovery and concentration
  • the invention relates to the production of growth-
  • factor-enriched fibrinogen concentrate from platelet-rich plasma.
  • thrombin a surgical patient intraoperatively and is combined with thrombin, usually in a seven-
  • the gel achieves faster haemostasis than do other conventional
  • the gel also seals air and fluid leakage due to its viscous
  • PDGF derived growth factors
  • the adhesive, tensile and shear strength of the clot formed by this gel is generally less than is desirable. Further, failure of haemostasis
  • volume e.g., 50ml
  • a fibrinogen-precipitating agent is placed in the second
  • the container is then placed in a centrifuge, and the whole blood is
  • the plasma e.g., PEG or ammonium sulfate.
  • the precipitating agent e.g., PEG or ammonium sulfate.
  • plasma from which fibrinogen is precipitated contains increased levels of platelets.
  • the fibrinogen yield obtained with prior art methods is generally about 50%
  • invention is about 72%, which represents a 44% increase in recovered fibrinogen.
  • is precipitated contains at least 50K platelets per mm 3 and preferably about
  • the disclosed invention produces FVIII and concentrated (up to 10+ fold
  • proteins preferably fibrinogen, FXIII, and recovered platelets (and
  • a clinically effective dose is produced from a smaller volume
  • the preferred method utilizes the dedicated centrifuge and disposable
  • a precipitating agent for example PEG or saturated
  • ammonium sulfate is placed in the second chamber.
  • the ammonium sulfate can be
  • ammonium sulfate 25% to 100% ammonium sulfate, and is preferably about 95% ammonium sulfate.
  • the disposable is loaded into the dedicated centrifuge as described in United States
  • Red cells are separated from whole blood in the centrifuge at a spin rate that
  • the spin rate is known as a "soft spin"
  • a precipitating agent such as PEG or ammonium sulfate
  • PRP has been found to provide greater protein (preferably fibrinogen)
  • PPP platelet poor plasma
  • a suitable diluent volume preferably a citrate buffer, is added to re-dissolve
  • a platelet gel is formed within seconds of application. The gel achieves
  • the gel's properties include FVIII and increased levels of
  • fibrinogen fibrinogen, FXIII, and greater than native levels of human growth factors.
  • TGF-B-1 TGF-B-1 and a thirty-fold increase in PDGF-AB.
  • the container was subjected to a hard spin to obtain a fibrinogen
  • pellet was about 72% a four-to-ten fold increase in TGF-B-1 and a thirty-fold

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Cell Biology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Thermal Sciences (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Materials Engineering (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ecology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Food Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

On obtient des rendements accrus d'un fibrinogène en ajoutant un agent précipitant à du plasma présentant une forte concentration de plaquettes, tel que le plasma enrichi aux plaquettes. Ledit agent précipitant peut être l'un quelconque de nombreux agents connus, y compris le polyéthylèneglycol et le sulfate d'ammonium. Dans la forme de réalisation préférée, on obtient du plasma enrichi aux plaquettes en soumettant le plasma à une centrifugation 'douce' d'environ 580G. Une centrifugeuse automatique à décantage multiple et vitesse variable est utilisée, de préférence, pour séparer du sang total anticoagulé en plasma enrichi aux plaquettes et en globules rouges. Les protéines, de préférence des fibrinogènes FXIII et FVIII du plasma enrichi aux plaquettes, sont précipités et les protéines et les plaquettes sont ensuite concentrées par une nouvelle centrifugation.
PCT/US1998/021626 1997-10-17 1998-10-16 Precipitation d'un concentre de fibrinogene enrichi d'un facteur de croissance obtenue a partir d'un plasma enrichi aux plaquettes WO1999020288A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2000516685A JP2001520198A (ja) 1997-10-17 1998-10-16 血小板富有血漿からの成長因子富有化フィブリノーゲン濃縮物の調製
CA002306629A CA2306629A1 (fr) 1997-10-17 1998-10-16 Precipitation d'un concentre de fibrinogene enrichi d'un facteur de croissance obtenue a partir d'un plasma enrichi aux plaquettes
EP98953467A EP1023078A4 (fr) 1997-10-17 1998-10-16 Precipitation d'un concentre de fibrinogene enrichi d'un facteur de croissance obtenue a partir d'un plasma enrichi aux plaquettes
US11/492,907 US20060261014A1 (en) 1997-10-17 2006-07-26 Precipitation of growth-factor-enriched fibrinogen concentrate from platelet rich plasma

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6226497P 1997-10-17 1997-10-17
US60/062,264 1997-10-17

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US09509545 A-371-Of-International 2000-04-28
US10/698,404 Continuation US20040092451A1 (en) 1997-10-17 2003-11-03 Precipitation of growth-factor-enriched fibrinogen concentrate from platelet rich plasma

Publications (1)

Publication Number Publication Date
WO1999020288A1 true WO1999020288A1 (fr) 1999-04-29

Family

ID=22041325

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/021626 WO1999020288A1 (fr) 1997-10-17 1998-10-16 Precipitation d'un concentre de fibrinogene enrichi d'un facteur de croissance obtenue a partir d'un plasma enrichi aux plaquettes

Country Status (5)

Country Link
EP (1) EP1023078A4 (fr)
JP (1) JP2001520198A (fr)
CN (1) CN1113656C (fr)
CA (1) CA2306629A1 (fr)
WO (1) WO1999020288A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003517888A (ja) * 1999-12-22 2003-06-03 ヘノゲン・ソシエテ・アノニム 骨産生製品
CN104711221A (zh) * 2015-02-15 2015-06-17 第五空间健康管理江苏有限公司 从成人外周血中自动化分离免疫细胞并提取prp的方法
WO2023132963A1 (fr) * 2022-01-04 2023-07-13 Phynexus, Inc. Purification de macromolécules

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1303413C (zh) * 2003-06-17 2007-03-07 余伟明 蛋白质、病毒快速富集方法
PH12014500352A1 (en) * 2004-11-12 2015-07-20 Bayer Healthcare Llc Site-directed modification of fviii
CN1908005B (zh) * 2006-08-11 2010-05-12 哈尔滨医科大学 一种复合蛋白沉淀剂
EP2077118A1 (fr) * 2008-01-07 2009-07-08 Gwo Rei Biomedical Technology Corp. Concentré coagulo-actif de facteurs de croissance de plaquettes et son procédé de préparation
CN105708858A (zh) * 2014-12-05 2016-06-29 国玺干细胞应用技术股份有限公司 富含生长因子的血小板纤维蛋白及其释放液的制备方法
CN107198893A (zh) * 2017-07-01 2017-09-26 张方亮 去白细胞prp的制备方法
CN108478864B (zh) * 2017-08-07 2020-10-23 上海交通大学医学院附属第九人民医院 复合纤维支架

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5030215A (en) * 1990-01-03 1991-07-09 Cryolife, Inc. Preparation of fibrinogen/factor XIII precipitate
US5226877A (en) * 1989-06-23 1993-07-13 Epstein Gordon H Method and apparatus for preparing fibrinogen adhesive from whole blood
US5585007A (en) * 1994-12-07 1996-12-17 Plasmaseal Corporation Plasma concentrate and tissue sealant methods and apparatuses for making concentrated plasma and/or tissue sealant
US5707331A (en) * 1995-05-05 1998-01-13 John R. Wells Automatic multiple-decanting centrifuge

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5510102A (en) * 1995-01-23 1996-04-23 The Regents Of The University Of California Plasma and polymer containing surgical hemostatic adhesives

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5226877A (en) * 1989-06-23 1993-07-13 Epstein Gordon H Method and apparatus for preparing fibrinogen adhesive from whole blood
US5030215A (en) * 1990-01-03 1991-07-09 Cryolife, Inc. Preparation of fibrinogen/factor XIII precipitate
US5585007A (en) * 1994-12-07 1996-12-17 Plasmaseal Corporation Plasma concentrate and tissue sealant methods and apparatuses for making concentrated plasma and/or tissue sealant
US5707331A (en) * 1995-05-05 1998-01-13 John R. Wells Automatic multiple-decanting centrifuge

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1023078A4 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003517888A (ja) * 1999-12-22 2003-06-03 ヘノゲン・ソシエテ・アノニム 骨産生製品
CN104711221A (zh) * 2015-02-15 2015-06-17 第五空间健康管理江苏有限公司 从成人外周血中自动化分离免疫细胞并提取prp的方法
WO2023132963A1 (fr) * 2022-01-04 2023-07-13 Phynexus, Inc. Purification de macromolécules

Also Published As

Publication number Publication date
CN1113656C (zh) 2003-07-09
EP1023078A4 (fr) 2004-09-29
CN1276725A (zh) 2000-12-13
EP1023078A1 (fr) 2000-08-02
CA2306629A1 (fr) 1999-04-29
JP2001520198A (ja) 2001-10-30

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