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WO1999007742A1 - Procede et dispositif de preparation de facteurs de croissance - Google Patents

Procede et dispositif de preparation de facteurs de croissance Download PDF

Info

Publication number
WO1999007742A1
WO1999007742A1 PCT/EP1998/004520 EP9804520W WO9907742A1 WO 1999007742 A1 WO1999007742 A1 WO 1999007742A1 EP 9804520 W EP9804520 W EP 9804520W WO 9907742 A1 WO9907742 A1 WO 9907742A1
Authority
WO
WIPO (PCT)
Prior art keywords
storage container
growth factors
platelet concentrate
blood
component separation
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP1998/004520
Other languages
German (de)
English (en)
Inventor
Ingo Flesch
Volker Brand
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to US09/463,476 priority Critical patent/US6325829B1/en
Priority to EP98941379A priority patent/EP1001988A1/fr
Priority to AU89779/98A priority patent/AU8977998A/en
Publication of WO1999007742A1 publication Critical patent/WO1999007742A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • C07K14/49—Platelet-derived growth factor [PDGF]

Definitions

  • the invention relates to a method for producing autologous, thrombocytic growth factors (growth factors). Furthermore, the invention relates to a device for producing autologous, thrombocytic growth factors (growth factors) and a system as part of a device for producing autologous thrombocytic growth factors (growth factors).
  • Wound healing of tissue defects on a body outer surface is usually controlled by the body in a natural way with the help of growth factors.
  • the body's own wound healing processes are often not sufficient the body's wound healing, for example, be chronically disturbed as a result of diabetes, so that wounds cannot heal naturally
  • the present invention is based on the problem of providing a method and a device for producing autologous thrombocytic growth factors (growth factors), wound growth being able to be stimulated with the aid of the produced growth factors. Furthermore, a system is intended as a component of a device for producing autologous thrombocytic Growth factors are provided to solve this problem, the method according to the invention is characterized by the following measures
  • a platelet concentrate is obtained from blood
  • the platelet concentrate is then degranulated, in particular by introducing thrombin and calcium into the platelet concentrate, a platelet agglomerate and a solution being formed,
  • the entire method is preferably carried out immediately after the blood is drawn as a bed-si de method. This also ensures that high concentrations of autologous thrombocytic growth factors can be produced or obtained
  • the device according to the invention for producing autologous, thrombocytic growth factors (growth factors) is characterized by
  • the device according to the invention enables the production or extraction of high concentrations of autologous, thrombocytic growth factors (growth factors).
  • the system according to the invention as a component of a device for producing autologous, thrombocytic growth factors is characterized by at least two storage containers, with a first storage container being assigned at least one inlet member and a second storage container being assigned at least one outlet member, the two storage containers being connected to one another by connecting lines and the system being connectable to a blood component separation system via a connecting member
  • the system according to the invention is of a particularly simple construction. It can be produced particularly cost-effectively. Furthermore, the system according to the invention can be used in connection with known and widely used blood component separation systems. Hospitals or the like are accordingly able at low cost to independently autologous, thrombocytic growth factors (growth factors ) to produce
  • FIG. 1 shows a system as part of a device for producing autologous, thrombocytic growth factors
  • the system shown in the drawing is part of a device for producing autologous, thrombocytic growth factors or autologous growth factors from whole blood With the help of the manufactured or obtained autologous groth factors, wound healing processes can be positively influenced.
  • FIG. 1 A system 10 as part of a device for producing autologous growth factors is shown in FIG. 1. With the aid of a connecting element 11, the system 10 can be connected to a blood component separation system, not shown.
  • This blood component separation system can be, for example, that of the company DIDECO S.p.A. Manufacture the autotransfusion device of the Compact-A series. However, any other blood component separation system can also be used
  • the system 10 has two storage containers 12, 13.
  • the storage containers 12, 13 are designed as bags.
  • the storage containers 12, 13 are connected on the one hand to one another and on the other hand to the blood component separation system (not shown).
  • the system 10 has connecting lines 14, 15.
  • the connecting lines 14, 15 are tubes.
  • one of the connecting lines 14 and 15 is connected via a first end 16 and 17 to one of the storage containers 12 and 13, respectively.
  • the connecting lines 14, 15 act on connection points 18, 19 of the storage containers 12, 13.
  • the connecting lines 14 and 15 are attached to a common connecting member 22, the connecting member 11 also engaging at one end 23 on the connecting member 22.
  • the connecting member 22 of the system 10 can be connected to the blood component separation system. The end 24 is closed when the system 10 is not in use 1 by a cap 25
  • the first storage container 12 of the system 10 has an inlet member 26. With the aid of the inlet member 26, substances can be introduced into the storage container 12 in a targeted and contamination-free manner.
  • the inlet member 26 comprises a connection member 27 as a connection to the storage container 12 and a 3-way arranged on the connection member 27. Tap 28 On the 3-way tap 28 is one Syringe 29 can be used, which contains the substances to be introduced into the storage container 12
  • the second reservoir 13 of the system 10 has an outlet member 30. With the aid of the outlet member 30, substances can be removed from the reservoir 13 in a targeted and contamination-free manner.
  • the outlet member 30, like the inlet member 26, has a connector 31 as a connection to the reservoir 13 and one on the connector 31 arranged 3-way tap 32 A syringe or the like, not shown, can be attached to the 3-way tap 32, by means of which the substances can be removed from the storage container 13
  • Both the storage container 12 and the storage container 13 each have a further connecting element 33, 34.
  • the connecting element 33, 34 are so-called retrans-adapters
  • a further connecting line 35 engages on the connecting member 22 in addition to the connecting lines 14, 15 and the connecting member 11.
  • An additional not shown inlet member can be attached to the connecting line 35 in order to introduce further south punches into the system 10 in a contamination-free manner Connection line 35 closed by a cap 36
  • the connecting lines ⁇ L 15, 35 are each assigned a clamping member 37, 38, 39, with the help of the clamping members 37, 38, 39 the flow direction within the system 10 can be determined
  • the blood namely whole blood immediately after blood collection or wa h rend of the non dargestel] th Blood component separation system supplied
  • the blood component separation system works on the principle of a centrifuge.
  • the blood component separation system extracts a platelet concentrate from the blood.
  • the platelet concentrate is supplied from the blood component separation system shown to the first reservoir 12 via the connecting line 14.
  • the clamping member 37 is opened
  • the clamping organs 38, 39 are closed. Unnecessary blood components such as erythrocytes, leukocytes and plasma are retransferred by the blood component separation system
  • the relevant specialist is familiar with the mode of operation and parameterization of the blood component separation system for obtaining the platelet concentrate.
  • whole blood at 350 * g g corresponds to gravitational acceleration
  • g corresponds to gravitational acceleration
  • the platelet-rich plasma can then be centrifuged at 1370 * g for 15 minutes. Platelets are pelleted. Surplus plasma is again discarded.
  • the desired platelet concentrate remains
  • the thrombocyte concentrate located in the first storage container 12 is then added, via the inlet member 26, a thrombi-calcium mixture located in the syringe 29.
  • the 3-way valve 28 is opened, the clamping member 37 is closed and the thrombin-calcium mixture is mixed is injected This takes place at room temperature
  • the thrombin-calcium mixture is a standard preparation according to the German Pharmacy Book (DAB).
  • DAB German Pharmacy Book
  • a dose of 5000 IU thrombin and 10 ml calcium 10% per 500 ml whole blood is used.
  • a variation of the thrombin concentration is possible, to achieve a different consistency (liquid to gel-like) of the growth factor mixture
  • the thrombin-calcium mixture accordingly has the following composition
  • thrombi-calcium mixture it is also conceivable to vary the thrombi-calcium mixture or to use other mixtures to degranulate the platelet concentrate. 1000 IU thrombin and 10 ml calcium 10% per 500 ml whole blood can also be used
  • the platelets in the platelet concentrate degranulate and release the so-called granules with the autologous growth factors located therein.
  • the platelets agglomerate to form a platelet agglomerate in the released autologous growth factors it is about
  • Fibroblast Growth Factors Pl at 1 et De ⁇ ved Growth Factors, Transforming Growth Factors, Fibronectin
  • the mixture of platelet concentrate and thrombi n-cal ci um mixture is transferred from the first storage container 12 to the second storage container 13.
  • the clamping member 37 and the clamping member 38 are opened.
  • the platelet aggregate is separated from the solution containing the autologous growth factors
  • the platelet agglomerate is discarded
  • the solution located in the storage container 13 is removed from the storage container 13 via the outlet member 30 to form portions.
  • the 3-way valve 1 32 is opened, to which a portion container or the like was previously attached. This is carried out until the entire in Storage container 13 located solution is divided into portions
  • the portioned solution is snap-frozen to a temperature of -40 ° C
  • the solution obtained in this way is mixed with homologous groth factors and / or buffer solution and / or dilution solution, and only afterwards this mixture is portioned and shock-frozen in order to admix the homologous groth factors and / or buffer solution and / or dilution solution is an inlet element, not shown, which can be connected to the connecting line 35
  • the shock-frozen portions can be thawed by the patient.
  • the portions can be applied to the wound daily to stimulate the wound healing process
  • the method according to the invention can also be carried out in a device with a storage container.
  • the platelet concentrate is mixed in one storage container with the thrombi-calzi um mixture and after agglomeration and granulation, the platelet agglomerate is simply clamped off separated from the solution containing the autologous growth factors in this one storage container

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne un procédé et un dispositif de préparation de facteurs de croissance autologues thrombocytaires, ainsi qu'un système faisant partie du dispositif de préparation de facteurs de croissance. Selon ce procédé, un concentré de thrombocytes est extrait du sang et une quantité définie de thrombine et de calcium est ensuite ajoutée audit concentré de thrombocytes. L'agglomérat de thrombocytes qui en résulte est alors séparé d'une solution contenant les facteurs de croissance. La solution qui en résulte est divisée en portions et congelée.
PCT/EP1998/004520 1997-07-22 1998-07-20 Procede et dispositif de preparation de facteurs de croissance Ceased WO1999007742A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US09/463,476 US6325829B1 (en) 1997-07-22 1998-07-20 Cup for a knee-joint prosthesis
EP98941379A EP1001988A1 (fr) 1997-08-05 1998-07-20 Procede et dispositif de preparation de facteurs de croissance
AU89779/98A AU8977998A (en) 1997-08-05 1998-07-20 Process and device for producing growth factors

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1997133899 DE19733899A1 (de) 1997-08-05 1997-08-05 Verfahren und Vorrichtung zur Herstellung autologer, thrombozytärer Wachstumsfaktoren sowie System als Bestandteil einer Vorrichtung zur Herstellung autologer, thrombozytärer Wachtstumsfaktoren
DE19733899.2 1997-08-05

Publications (1)

Publication Number Publication Date
WO1999007742A1 true WO1999007742A1 (fr) 1999-02-18

Family

ID=7838077

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/004520 Ceased WO1999007742A1 (fr) 1997-07-22 1998-07-20 Procede et dispositif de preparation de facteurs de croissance

Country Status (4)

Country Link
EP (1) EP1001988A1 (fr)
AU (1) AU8977998A (fr)
DE (1) DE19733899A1 (fr)
WO (1) WO1999007742A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2221770A1 (es) * 2002-04-19 2005-01-01 Eduardo Anitua Aldecoa Metodo de preparacion de un compuesto para la regeneracion de tejidos.

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19960490A1 (de) * 1999-12-15 2001-07-12 Curasan Ag Regenerationsmittel
DE19960504A1 (de) * 1999-12-15 2001-08-16 Curasan Ag Regenerationsmittel

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993025215A1 (fr) * 1992-06-05 1993-12-23 Inoteb Dispositif permettant l'obtention d'un surnageant de thrombocytes actives, procede mettant en ×uvre le dispositif et surnageant obtenu

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993025215A1 (fr) * 1992-06-05 1993-12-23 Inoteb Dispositif permettant l'obtention d'un surnageant de thrombocytes actives, procede mettant en ×uvre le dispositif et surnageant obtenu

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2221770A1 (es) * 2002-04-19 2005-01-01 Eduardo Anitua Aldecoa Metodo de preparacion de un compuesto para la regeneracion de tejidos.
ES2221770B2 (es) * 2002-04-19 2006-07-16 Eduardo Anitua Aldecoa Metodo de preparacion de un compuesto para la regeneracion de tejidos.

Also Published As

Publication number Publication date
DE19733899A1 (de) 1999-02-11
EP1001988A1 (fr) 2000-05-24
AU8977998A (en) 1999-03-01

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