DE01201546T1 - Osteogene Einrichtungen - Google Patents

Osteogene Einrichtungen Download PDF

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Publication number
DE01201546T1
DE01201546T1 DE0001225225T DE01201546T DE01201546T1 DE 01201546 T1 DE01201546 T1 DE 01201546T1 DE 0001225225 T DE0001225225 T DE 0001225225T DE 01201546 T DE01201546 T DE 01201546T DE 01201546 T1 DE01201546 T1 DE 01201546T1
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protein
osteogenic
matrix
mammal
amino acid
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DE20101546U1 (de
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Thangavel Kuberasampath
Hermann Medway Oppermann
David C. West Roxbury Rueger
Engin Milford Ozkaynak
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Stryker Corp
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Stryker Corp
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Priority claimed from US07/179,406 external-priority patent/US4968590A/en
Priority claimed from US07/315,342 external-priority patent/US5011691A/en
Application filed by Stryker Corp filed Critical Stryker Corp
Publication of DE01201546T1 publication Critical patent/DE01201546T1/de
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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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • 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
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A61L27/365—Bones
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A61L27/3654—Cartilage, e.g. meniscus
    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475—Growth factors; Growth regulators
    • C07K14/51—Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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

Abstract

Verwendung einer Zusammensetzung, welche im wesentlichen aus einer einzigen Spezies eines osteogenen Proteins als osteogen aktivem Bestandteil besteht, wobei das Protein eine unpaarige Polypeptidkette aufweist, welche zum Induzieren von enchondraler Knochenbildung geeignet ist, wenn sie an einer Matrix angeordnet und einem Säuger implantiert wird, zur Herstellung eines Medikamentes zum Induzieren von enchondraler Knochenbildung.

Claims (15)

  1. Verwendung einer Zusammensetzung, welche im wesentlichen aus einer einzigen Spezies eines osteogenen Proteins als osteogen aktivem Bestandteil besteht, wobei das Protein eine unpaarige Polypeptidkette aufweist, welche zum Induzieren von enchondraler Knochenbildung geeignet ist, wenn sie an einer Matrix angeordnet und einem Säuger implantiert wird, zur Herstellung eines Medikamentes zum Induzieren von enchondraler Knochenbildung.
  2. Verwendung einer Zusammensetzung, welche im wesentlichen aus einer einzigen Spezies eines osteogenen Proteins als osteogen aktivem Bestandteil besteht, wobei das osteogene Protein nicht ein Paar von Polypeptidketten aufweist und zum Induzieren von enchondraler Knochenbildung geeignet ist, wenn sie an einer Matrix angeordnet und einem Säuger implantiert wird, zur Herstellung eines Medikamentes zum Induzieren von enchondraler Knochenbildung.
  3. Osteogenes Protein, welches eine unpaarige Polypeptidkette aufweist, die zum Induzieren von enchondraler Knochenbildung geeignet ist, wenn sie an einer Matrix angeordnet und einem Säuger implantiert wird, wobei das Protein in nicht glykolysierter Form vorliegt.
  4. Osteogenes Protein, welches eine Polypeptidkette aufweist, die zum Induzieren von enchondraler Knochenbildung geeignet ist, wenn sie an einer Matrix angeordnet und einem Säuger implantiert wird, wobei das Protein nicht ein Paar von Polypeptidketten aufweist und in nicht glykolysierter Form vorliegt.
  5. Verfahren zur Herstellung einer Polypeptidkette zur Verwendung bei der Herstellung eines aktiven osteogenen Proteins, wobei das Verfahren die folgenden Schritte umfaßt: (a) Bereitstellen von genetischem Material, welches das osteogene Protein codiert; (b) Einführen des genetischen Materials in eine prokaryotische Gastzelle; (c) Expression des genetischen Materials in der Gastzelle; und (d) Falten des exprimierten Proteins durch Oxidation.
  6. Verfahren nach Anspruch 5, wobei das Protein eine TGF-beta-artige Domäne mit Sieben-Cysteinen aufweist.
  7. Polypeptidkette, welche mittels eines Verfahrens nach Anspruch 5 oder 6 herstellbar ist.
  8. Verwendung nach Anspruch 1 oder 2, Protein nach Anspruch 3 oder 4, Verfahren nach Anspruch 5 oder 6 oder Polypeptid nach Anspruch 7, wobei das Protein (a) die Aminosäuresequenz VPKPCCAPT aufweist; oder (b) die Aminosäuresequenz
    Figure 00030001
    aufweist; oder (c) die Aminosäuresequenz
    Figure 00030002
    aufweist; oder (d) die Aminosäuresequenz
    Figure 00030003
    aufweist; oder (e) die Aminosäuresequenz
    Figure 00030004
    aufweist; oder (f) die Aminosäuresequenz
    Figure 00040001
    aufweist; oder (g) diejenige Sequenz von Aminosäuren aufweist, welche durch eine DNS-Sequenz codiert wird, die durch Hybridisierung mit der Probe gemäß 13 erhältlich ist.
  9. Verwendung nach Anspruch 1 oder 2, Protein nach Anspruch 3 oder 4, verfahren nach Anspruch 5 oder 6, Polypeptid nach Anspruch 7 oder Verwendung, Protein, Verfahren oder Polypeptid nach Anspruch 8, wobei das Protein: (a) in der glykolysierten, nativen Form ein scheinbares Molekulargewicht von etwa 30 kD aufweist, wie es mittels SDS-PAGE ermittelt worden ist; oder (b) in der deglykolysierten Form ein scheinbares Molekulargewicht von etwa 27 kD aufweist, wie es mittels SDS-PAGE ermittelt worden ist; oder (c) zwei Polypeptidketten aufweist, welche in der glykolysierten Form ein scheinbares Molekulargewicht von etwa 16 kD und 18 kD aufweisen; oder (d) zwei Polypeptidketten aufweist, welche in der nicht glykolysierten Form ein scheinbares Molekulargewicht von etwa 14 kD bis 16 kD aufweisen.
  10. Verfahren nach einem der Ansprüche 5 bis 9, wobei die Gastzelle eine Gastzelle von E. coli ist.
  11. Verfahren zur Herstellung einer osteogenen Einrichtung, welches die Anordnung eines Proteins nach einem der vorangehenden Ansprüche an einer Matrix umfaßt.
  12. Verfahren nach Anspruch 11, wobei die Einrichtung zur Implantation in einem Säuger geeignet ist und (a) eine biokompatible, in vivo biologisch abbaubare Matrix aufweist, welche Poren mit hinreichenden Abmessungen bildet, um die Einfuhr, Proliferation und Differenzierung von Wander-Progenitorzellen des Körpers dieses Säugers zu ermöglichen; und (b) das Protein an dieser Matrix angeordnet und diesen Zellen zugänglich ist.
  13. Verfahren nach Anspruch 13, wobei die Matrix ein dicht gepacktes partikuläres Material mit einer Partikelgröße im Bereich von 70 um bis 420 um aufweist.
  14. Verfahren nach einem der Ansprüche 11 bis 13, wobei die Matrix umfaßt: (a) allogenes Knochenmaterial, z.B. demineralisiertes, Protein extrahiertes, partikuläres, allogenes Knochenmaterial; (b) demineralisiertes, Protein extrahiertes, partikuläres, deglykolysiertes, xenogenes Knochenmaterial (welches z.B. mit einer Protease behandelt worden ist); (c) demineralisiertes, Protein extrahiertes, partikuläres, xenogenes, mit HF behandeltes Knochenmaterial; (d) Materialien aus der Gruppe Kollagen, Hydroxyapatit, Calciumphosphate (z.B. Tricalciumphosphat) und Polymere mit Monomeren aus Glykolsäure und/oder Milchsäure; (e) ein formstabiles, festes oder lose gebundenes, partikuläres Material, z.B. Kollagen; (f) ein poröses Feststoffmaterial; (g) zerkleinertes Gewebe, z.B. Muskelgewebe; oder (h) die Markhöhle von allogenem Knochenmaterial.
  15. Verfahren nach einem der Ansprüche 11 bis 14, wobei die Einrichtung zur Verwendung in der Therapie geeignet ist, z.B. zum Induzieren von lokaler Knorpel- und/oder enchondraler Knochenbildung in einem Säuger mittels Implantieren der Einrichtung in einen Säuger an einer Stelle, welche für Wander-Progenitorzellen zugänglich ist, für Periodontalbehandlungen, Knorpelbehandlungen, zur Beschleunigung von Allotransplantationsbehandlungen und zur Behandlung von Osteaarthritis oder zur Korrektur von vollständigen Frakturen, erworbenen oder angeborenen Schädelanomalien, anderen skelettalen oder dentalen Anomalien.
DE0001225225T 1988-04-08 1989-04-07 Osteogene Einrichtungen Pending DE01201546T1 (de)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US07/179,406 US4968590A (en) 1988-04-08 1988-04-08 Osteogenic proteins and polypeptides
US179406 1988-04-08
US23263088A 1988-08-15 1988-08-15
US232630 1988-08-15
US315342 1989-02-23
US07/315,342 US5011691A (en) 1988-08-15 1989-02-23 Osteogenic devices

Publications (1)

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DE01201546T1 true DE01201546T1 (de) 2004-07-08

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Application Number Title Priority Date Filing Date
DE68929453T Expired - Lifetime DE68929453T2 (de) 1988-04-08 1989-04-07 Osteogene Vorrichtungen
DE0001221484T Pending DE01201555T1 (de) 1988-04-08 1989-04-07 Biosynthetische osteogene Proteine und solche enthaltende osteogene Einrichtungen
DE68929472T Revoked DE68929472T2 (de) 1988-04-08 1989-04-07 Biosynthetische knochenbildende Proteine, und sie enthaltende knochenbildende Vorrichtungen
DE68925773T Expired - Lifetime DE68925773T2 (de) 1988-04-08 1989-04-07 Osteogene vorrichtungen
DE0001225225T Pending DE01201546T1 (de) 1988-04-08 1989-04-07 Osteogene Einrichtungen
DE68927153T Expired - Lifetime DE68927153T2 (de) 1988-04-08 1989-04-07 Biosynthetische osteogene proteine und sie enthaltende osteogene vorrichtungen

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DE68929453T Expired - Lifetime DE68929453T2 (de) 1988-04-08 1989-04-07 Osteogene Vorrichtungen
DE0001221484T Pending DE01201555T1 (de) 1988-04-08 1989-04-07 Biosynthetische osteogene Proteine und solche enthaltende osteogene Einrichtungen
DE68929472T Revoked DE68929472T2 (de) 1988-04-08 1989-04-07 Biosynthetische knochenbildende Proteine, und sie enthaltende knochenbildende Vorrichtungen
DE68925773T Expired - Lifetime DE68925773T2 (de) 1988-04-08 1989-04-07 Osteogene vorrichtungen

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DE68927153T Expired - Lifetime DE68927153T2 (de) 1988-04-08 1989-04-07 Biosynthetische osteogene proteine und sie enthaltende osteogene vorrichtungen

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US (4) US5814604A (de)
EP (6) EP0714665B1 (de)
JP (5) JP2522568B2 (de)
AT (4) ATE134647T1 (de)
AU (2) AU628050B2 (de)
CA (2) CA1341610C (de)
DE (6) DE68929453T2 (de)
WO (2) WO1989009788A2 (de)

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