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WO2008006430A1 - Procédé de préparation cellulaire de cellules mononucléaires de moelle osseuse - Google Patents

Procédé de préparation cellulaire de cellules mononucléaires de moelle osseuse Download PDF

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Publication number
WO2008006430A1
WO2008006430A1 PCT/EP2007/005075 EP2007005075W WO2008006430A1 WO 2008006430 A1 WO2008006430 A1 WO 2008006430A1 EP 2007005075 W EP2007005075 W EP 2007005075W WO 2008006430 A1 WO2008006430 A1 WO 2008006430A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone marrow
volume
blood
peripheral blood
preparation
Prior art date
Application number
PCT/EP2007/005075
Other languages
German (de)
English (en)
Inventor
Kai Jaquet
Original Assignee
Asklepios Kliniken Hamburg Gmbh
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 Asklepios Kliniken Hamburg Gmbh filed Critical Asklepios Kliniken Hamburg Gmbh
Publication of WO2008006430A1 publication Critical patent/WO2008006430A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0652—Cells of skeletal and connective tissues; Mesenchyme
    • C12N5/0662—Stem cells
    • C12N5/0663—Bone marrow mesenchymal stem cells (BM-MSC)
    • 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
    • A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells

Definitions

  • the invention relates to a method for cell preparation of mononuclear cells from bone marrow, in particular for use in stem cell therapy after myocardial infarction.
  • the damaged heart muscle tissue is not or not sufficiently recovered, resulting in limited physical performance.
  • the deterioration of the pumping function of the heart can be stopped by a cell transplantation of bone marrow cells of the same patient.
  • mononuclear cells must be separated from the bone marrow and the patient treated with the separated cell fraction.
  • the cell preparation is carried out in a special laboratory. This is very expensive. These costs are partly due to statutory provisions of the German Medicines Act, but these do not apply if the collection, preparation and transplantation are in the hands of one and the same natural person (doctor) and the cells are prepared under clean room conditions. It is therefore desirable to carry out the cell preparation at the treatment site.
  • the preparation under clean room conditions is a problem.
  • the object of the invention is to provide a method for cell preparation of mononuclear cells from bone marrow, which can be carried out with reasonable equipment and economic effort on site and under the supervision of a natural person.
  • the solution according to the invention provides that a large volume of peripheral blood is added to a small volume of bone marrow and in that the preparation of the mononuclear cells under clean room conditions is carried out by means of a commercial, fully automatic apheresis apparatus intended for the separation of blood components from blood.
  • the method of the invention works best when a volume of 30 ml to 150 ml of bone marrow is mixed with a volume of 150 ml to 350 ml of peripheral blood.
  • the bone marrow and the peripheral blood are mixed in a blood bag outside the apheresis apparatus, because the blood taken from the patient is usually filled in such a blood bag, which is also suitable for receiving the bone marrow.
  • the blood bag is particularly well suited for mechanical mixing of the two components.
  • the apheresis apparatus is adjusted by suitable programming so that the highest possible concentration of the mononuclear cell fraction in the smallest possible final volume is achieved.
  • the programming is preferably carried out in accordance with the operating instructions of the apheresis apparatus.
  • the volume of the mononuclear cell fraction obtained should be about 5 ml to 7 ml. Much larger volumes would be impractical in administering the cell fraction for therapy.
  • the small final volumes can be administered by means of a commercially available syringe.
  • the apheresis apparatus is sterile connected to a syringe instead of a conventional collection bag for receiving the separated cell fraction.
  • the invention also includes the use of a "Spectra Therapeutic Platform” from Gambo Inc., Lakewood, Colorado, USA for the preparation of a mononuclear cell fraction from a mixture of a small volume of bone marrow and a larger volume of peripheral blood because of positive experience with this machine ,
  • the heart of a patient should be treated after having suffered myocardial infarction by means of mononuclear cells to restore its performance.
  • a doctor removes 250 ml of blood from the patient, which is collected in a blood bag. Furthermore, the doctor takes the patient 50 ml of bone marrow. The bone marrow is placed under sterile conditions in the blood bag and mixed by hand with the blood. A mixture of 300 ml volume is obtained.
  • the blood bag is connected to a "Spectra Therapeutic Platform" apheresis apparatus from Gambro Inc., Lakewood, Colorado, USA, which under sterile conditions separates the mononuclear cell fraction of bone marrow cells under clean room conditions from the mixture of bone marrow and peripheral blood in a fully automated manner
  • the apheresis apparatus is sterile connected to a syringe designed to receive the mononuclear cell fraction, which has a volume of 10 ml the syringe is picked up.
  • the doctor can remove the syringe and inject the recovered mononuclear cell fraction for therapy purposes in the heart of the patient.
  • the invention does not relate to this therapy, but only to the cell preparation.
  • the inventive method is very cost-effective, because even with the purchase of a said apheresis system especially for the cell preparation according to the invention suburb lower costs are caused than in a cell preparation in a special laboratory. In addition, in many cases, such Apheresesytem anyway for other purposes will be available, so that the costs can be further reduced thereby.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Virology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un procédé particulièrement économique de préparation cellulaire de cellules mononucléaires de moelle osseuse, selon lequel un petit volume de moelle osseuse est ajouté à un grand volume de sang périphérique et selon lequel la préparation de cellules mononucléaires est effectuée, en conditions de salle blanche, dans un appareil d'aphérèse usuel, entièrement automatique et destiné à séparer les constituants du sang.
PCT/EP2007/005075 2006-07-10 2007-06-08 Procédé de préparation cellulaire de cellules mononucléaires de moelle osseuse WO2008006430A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006031872.2 2006-07-10
DE102006031872A DE102006031872B3 (de) 2006-07-10 2006-07-10 Verfahren zur Zellpräparation von mononukleären Zellen aus Knochenmark

Publications (1)

Publication Number Publication Date
WO2008006430A1 true WO2008006430A1 (fr) 2008-01-17

Family

ID=38347866

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2007/005075 WO2008006430A1 (fr) 2006-07-10 2007-06-08 Procédé de préparation cellulaire de cellules mononucléaires de moelle osseuse

Country Status (2)

Country Link
DE (1) DE102006031872B3 (fr)
WO (1) WO2008006430A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003012060A2 (fr) * 2001-08-01 2003-02-13 Jewish Hospital Healthcare Services, Inc. Compositions cellulaires facilitant le greffage des cellules souches hematopoietiques et minimisant le risque de gvhd
WO2005004886A1 (fr) * 2003-07-09 2005-01-20 Sdgi Holdings, Inc. Isolement d'une fraction de moelle osseuse riche en constituants de croissance de tissu conjonctif et son utilisation pour favoriser la formation de tissu conjonctif

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003012060A2 (fr) * 2001-08-01 2003-02-13 Jewish Hospital Healthcare Services, Inc. Compositions cellulaires facilitant le greffage des cellules souches hematopoietiques et minimisant le risque de gvhd
WO2005004886A1 (fr) * 2003-07-09 2005-01-20 Sdgi Holdings, Inc. Isolement d'une fraction de moelle osseuse riche en constituants de croissance de tissu conjonctif et son utilisation pour favoriser la formation de tissu conjonctif

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CASSENS U ET AL: "Efficacy and kinetics of bone marrow processing and enrichment of haematopoietic progenitor cells (HPC) by a large-volume apheresis procedure", BONE MARROW TRANSPLANTATION, vol. 19, no. 8, 1997, pages 835 - 840, XP002447412, ISSN: 0268-3369 *
HUMPE A ET AL: "ABO-mismatched marrow transplantation: removal of mismatched donor red blood cells by "washing" with recipient's matched red blood cells in a closed system.", TRANSFUSION DEC 2005, vol. 45, no. 12, December 2005 (2005-12-01), pages 1985 - 1987, XP002447413, ISSN: 0041-1132 *
ITOH T ET AL: "Predictive value of the original content of CD34(+) cells for enrichment of hematopoietic progenitor cells from bone marrow harvests by the apheresis procedure.", JOURNAL OF CLINICAL APHERESIS OCT 2006, vol. 21, no. 3, 17 April 2006 (2006-04-17), pages 176 - 180, XP002447411, ISSN: 0733-2459 *

Also Published As

Publication number Publication date
DE102006031872B3 (de) 2007-10-18

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