WO2003075789A2 - Double don de sang et procédé - Google Patents

Double don de sang et procédé Download PDF

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Publication number
WO2003075789A2
WO2003075789A2 PCT/US2003/006317 US0306317W WO03075789A2 WO 2003075789 A2 WO2003075789 A2 WO 2003075789A2 US 0306317 W US0306317 W US 0306317W WO 03075789 A2 WO03075789 A2 WO 03075789A2
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WIPO (PCT)
Prior art keywords
blood
donor
family
components
layer component
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Application number
PCT/US2003/006317
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English (en)
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WO2003075789A3 (fr
Inventor
Daniel D. Richard
Original Assignee
Richard Daniel D
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Publication date
Application filed by Richard Daniel D filed Critical Richard Daniel D
Priority to AU2003219966A priority Critical patent/AU2003219966A1/en
Publication of WO2003075789A2 publication Critical patent/WO2003075789A2/fr
Publication of WO2003075789A3 publication Critical patent/WO2003075789A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • 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
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0647—Haematopoietic stem cells; Uncommitted or multipotent progenitors

Definitions

  • the invention provides methods enabling: (1) a blood donor to utilize the buffy coat of a blood sample to provide for autologous and/or allogeneic transplantation of certain components within the buffy coat; (2) segregation of a blood sample into component parts, including at least two samples, wherein a first sample is directed to autologous treatment of the blood donor or donor family member (an allogeneic treatment), and the other sample is directed to allogenic treatment of diseases or organ creation for the general population (non-family members). Blood samples may be cryopreserved before use in the instant invention.
  • blood samples are: (1) separated into components of the buffy coat and in particular, stem and/or progenitor cells; (2) genetically analyzed to assess genetic predisposition to disease in a donor family history; and (3) are dedicated to use by a donor family member in the event the family member succumbs to a disease state consistent with the genetic analysis.
  • allogeneic blood products are donated by or received from family members or known or unknown individuals; such blood products are referred to as "allogeneic" products.
  • allogeneic blood supply was contaminated with the human immunodeficiency virus (HIV). This immediately heightened public awareness and caused concern among health care professionals, patients and the media related to safe administration of blood transfusions.
  • HAV human immunodeficiency virus
  • allogeneic blood For the use of allogeneic blood, conventional blood bank practice is to collect blood from an acceptable donor in citrate to prevent coagulation. Several components are separated from the collected blood including packed red blood cells, platelets and plasma. It is also a common practice for plasma and platelets to be collected using pheresis techniques. As is well known by those skilled in the art, allogeneic whole blood is rarely used. The blood products collected at blood banks are then stored in accordance with shelf-life survivability expectations. Prior to administering allogeneic blood, the patient's blood is cross-matched to assure its compatibility with the patient's blood type.
  • Whole blood consists essentially of red blood cells, white blood cells, platelets and plasma. These components are required for different therapeutic usages and therefore whole blood resulting from a donation is generally processed in order to extract them. This is done in two steps.
  • a first step consists in collecting whole blood from a donor into a primary bag containing an anticoagulant solution.
  • a typical blood donation lasts between 5-10 min., to collect a fixed volume generally of 450 ml of whole blood. This fixed volume excludes a certain range of the donor population due to risks of hypovolemia, as standard blood bank practices limit collection to 15% of the total blood volume of a donor.
  • the donor is released and the second step can be initiated. It consists in separating the blood into its sub-components through a batch process.
  • blood is donated to a blood bag via a blood draw off tube permanently connected to the bag.
  • a number of side bags are connected to the blood bag by means of tubes. These connections are normally collected in the upper edge of the blood bag.
  • the blood bag is centrifuged upright in a centrifuge cup, such that the blood forms layers, viz. an uppermost plasma layer, a subjacent buffy coat layer (comprised largely of platelets/white cells) whose volume is relatively small, and a lowermost layer of red blood cells.
  • Blood tests are required to diagnose internal diseases. These blood tests can be divided into tests regarding the cellular blood components (blood count, differential blood count, blood group, immunophenotyping of blood cells) and into serum tests and also into antibody screening tests, Coombs tests and cross-matching tests. Serum tests are concerned with the determination of enzymes, metabolic products (e.g. creatinine, urea, blood sugar) and coagulation parameters. In addition, special tests, such as hormone analyses or drug level analyses, are carried out on the basis of serum.
  • U.S. Patent No. 6,165,716 describes screening blood derived samples for disorders of serotonergic dysfunction.
  • U.S. Patent No. 6,153,378 describes an improved detection and diagnosis of a positive-stranded RNA virus in a serological sample.
  • An emerging area of cancer treatment is immunotherapy.
  • This can involve adoptive immunotherapy using stimulated autologous cells of various kinds and systemic transfer of allogeneic lymphocytes.
  • the first of these strategies, adoptive immunotherapy is directed towards providing the patient with a level of enhanced immunity by stimulating cells ex vivo, and then readministering them to the patient.
  • the cells are histocompatible with the subject, and are generally obtained from a previous autologous donation.
  • One version is to stimulate autologous lymphocytes ex vivo with tumor-associated antigen to make them tumor-specific.
  • Zarling et al. (1978) Nature 274:269-71 generated cytotoxic lymphocytes in vitro against autologous human leukemia cells.
  • Osband suggests activating a tumor patient's mononuclear cells by culturing them ex vivo in the presence of tumor cell extract and a non-specific activator like phytohemagglutinin or IL-1, and then treating the culture to deplete suppresser cell activity.
  • a non-specific activator like phytohemagglutinin or IL-1
  • Autologous lymphocytes and killer cells may also be stimulated non-specifically.
  • Fc receptor expressing leukocytes that can mediate an antibody-dependent cell- mediated cytotoxicity reaction are generated by culturing with a combination of IL-2 and IFN- .gamma. (U.S. Pat. No. 5,308,626).
  • peripheral blood-derived lymphocytes cultured in IL-2 form lymphokine-activated killer (LAK) cells, which are cytolytic towards a wide range of neoplastic cells, but not normal cells.
  • LAK cells have had some success in the treatment of metastatic human melanoma and renal cell carcinoma. Rosenberg (1987) New Engl. J Med.
  • TILs tumor-infiltrating lymphocytes
  • IL-2 tumor-infiltrating lymphocytes
  • TILs have activity and tumor specificity superior to LAK cells, and have been experimentally administered, for example, to humans with advanced melanoma. Rosenberg et al. (1990) New Engl. J. Med. 323:570-578. Unfortunately, TILs can only be prepared in sufficient quantity to be clinically relevant in a limited number of tumor types, and remain experimental.
  • United States Patent No. 6,444,664 describes a method for controlling the plasma level of lipoproteins to treat Alzheimers disease.
  • the present invention relates to a method of utilizing the buffy coat (a layer containing mononuclear cells after centrifugation of a blood sample) of a blood sample, which is normally discarded after blood donations, and providing the donor of blood with the option of enabling autologous and/or allogeneic transplantation of certain components within the buffy coat, especially including pluripotent stem cells, or progenitor cells which are precursors of cells which are found in tissue throughout the human body including hematopoietic cells, neural cells including brain cells, heart cells, muscle cells, kidney cells, liver cells, marrow cells, cytoskeletal cells, lung cells, liver cells, among numerous others. These stem and/or progenitor cells may be expanded up to a million times or more to produce cells, tissue and organs which may be used in autologous or allogeneic transplant.
  • pluripotent stem cells or progenitor cells which are precursors of cells which are found in tissue throughout the human body including hematopoietic cells, neural cells including brain cells, heart
  • the invention provides a method of allocating donor blood sample components for autologous or allogeneic use within or without a blood donor family, comprising:
  • donor blood sample components comprising a plasma layer component, a buffy coat layer component, and a red blood cell layer component
  • step (c) allocating the buffy coat layer component for autologous or allogeneic use within or without a blood donor family on the basis of a comparison of the results of the analysis of step (b) with predetermined donor or blood donor family instructions;
  • the buffy coat sample containing mononuclear and stem/progenitor cells may be further separated into cellular components found within the buffy coat, optionally cryopreserved and stored according to methods which are well- known in the art, and before use, expanded using any one or more of the methods known in the art, including methods which are disclosed in United States Patent Nos. 6,335,195 and 6,247,587 to Rogers, et al., 6,316,257 to Flyer, et al., 6,284,142 to Midler and 6,251,615 to Oberhordl, among numerous others.
  • stem and/or progenitor cells from a given sample may be thawed (if first cryopreserved) and expanded to produce effective numbers of stem and/progenitor cells for a particular use.
  • the invention also provides database systems and related pooling and inventory methods that optimize autologous or allogeneic use of serological samples. Optimized diagnostic procedures are also provided.
  • the use of the subject invention in blood collection centers such as blood banks, bloodmobiles, mobile blood donation units, plasma centers, laboratories, hospitals, doctor's offices and other blood collection centers makes the present method generally applicable and quite facile to employ, h addition, the present method makes the use of these blood collection facilities even more attractive to potential donors, resulting in increased donation of blood, a worthy benefit which complements the present invention.
  • the present invention is also advantageous as an attractive way to increase blood donation and rectify shortages, to obtain non-controversial biological material for research purposes, including stem and/or progenitor cells, or to encourage adults to cryopreserve their own cellular material which may be of considerable therapeutic use either in the near future or with future technological advances and preserve today for tomorrow's technology 5 " 1 .
  • Allogeneic means derived from a source other than a transfusion recipient or a recipient of donated cells.
  • Blood borne pathogen means any composition or factor that is found in blood and that is associated with a disease state (e.g., any virus, viral particle, virus coat, parasite, toxin, bacteria, or harmful exogenous substance).
  • “Buffy coat” is one of the blood layers formed upon centrifugation of a blood sample; it is comprised largely of mononuclear cells including platelets/white cells. Upon centrifugation of the sample, the buffy coat is subadjacent to an uppermost plasma layer and is below a lowermost layer of red blood cells.
  • Genetic marker means genes, DNA sequences, heterochromatic regions, or any other distinguishing features of genotypes, chromosomes, or karyotypes that may be used to keep track of specific chromosomes, cells, or individuals.
  • Serological data means any information relating to a blood sample derived from an autologous or allogenic source.
  • Methods according to the present invention allow for the isolation of aliquots of a blood donation sample or particular types of cells, such as stem and/or progenitor cells from a donor blood sample; these may be crypreserved and stored pursuant to methods which are well known in the art.
  • a donor's family history is reviewed to determine the cause of death of any family members and the likelihood that a family or a given individual may be genetically predisposed for a disease or condition.
  • the sample may be separated into components of the buffy coat and in particular, stem and/or progenitor cells, which could be used in the event that a family member becomes stricken with a disease state consistent with the genetic predisposition in the family history.
  • the approach disclosed herein may be used to provide as many samples as may be needed for purposes of treating an entire family for all the potential disease states consistent with the family medical history, which can be cryopreserved and separately stored or stored together.
  • Methods which are well-known in the art may be used to separate the buffy coat from the remaining blood components during the donor process (for example, a ficoll-hypaque centrifugation procedure or other related procedure), and the donor may thereafter, prior to cryopreservation of the buffy coat, make certain decisions about the use of the cells within the buffy coat.
  • the donor may decide to donate or sell a certain sample size to the public or anonymous third parties and/or keep the sample for the treatment of disease states and/or conditions which afflict himself/herself.
  • the donor may also decide, after having a family medical history review, to have the sample separated into cellular components using genetic markers (a technology well-known in the art) such as CD 34 antigens and other cell surface markers, as an insurance sample against diseases states for which there is a family predisposition.
  • genetic markers a technology well-known in the art
  • CD 34 antigens and other cell surface markers as an insurance sample against diseases states for which there is a family predisposition.
  • the present invention may function as insurance methods for treating disease states.
  • one or more samples may be prepared and stored (using standard cryopreservation techniques), which contain an enriched sample of stem cells and/or progenitor cells wliich may be thawed, expanded and used in therapeutic methods for example, for restoring brain function in neurodegenerative disease states, for providing tissue for use in surgery to prepare lung tissue damaged by cancer, for hematopoietic reconstitution in leukemias and numerous other disease states otherwise disclosed or described in U.S. Patent Nos. 5,004,681 and 5,192,553, relevant portions of which are incorporated by reference herein.
  • the invention provides a method comprising pooling into a serological collection blood donor sample components that have been (1) obtained from a plurality of donors, and (2) that have been allocated according to donor, donor family, or collection sample management instructions, wherein:
  • serological component allocation can be optimized at the level of family, clinical treatment center or blood donation site, municipality, state, nation, or even internationally.
  • relatives within an extended family may effectively coordinate useful blood component donations, and may proactively provide for useful serological reserves over great distances.
  • Information relating to family health care profiles can be analyzed effectively to employ genetic markers to identify optimum blood donation plans and blood component allocation.
  • a computer network for maintaining and transferring data reflecting pooled serological collection blood donor sample components comprises an information storage device containing data reflecting pooled serological collection blood donor sample components that have been: (1) obtained from a plurality of donors, (2) allocated as described above, and (3) segregated for use according to their predete ⁇ nined allocation, hi this info ⁇ nation storage device, an inventory of blood donor sample components is maintained, correlated for intended use, and is updated on the basis of input data reflecting addition or subtraction of blood donor sample components from the serological collection.
  • the invention provides a program for monitoring data reflecting pooled serological collection blood donor sample components.
  • the program resides on a computer readable medium having computer readable program code means and comprises a computer system input for transmission of data reflecting pooled serological collection blood donor sample components that have been: (1) obtained from a plurality of donors, (2) allocated as described above, and (3) segregated for use according to their predetermined allocation; means for analyzing serological data for a plurality of donors.
  • the program provides physical health indicators and serological profile data for access at the time of blood donation.
  • the program monitors acceptability of a donor's serological profile, and controls an output of recommended actions for the donor, in response to results from said analysis indicating that the serological profile data are inside or outside of a normal range for the particular user.
  • the program enables reception of the serological profile in an extensible mark-up language data format.
  • a donor may continually monitor his or her serological profile and may serological allocation decisions in accordance with the invention on a real time basis.
  • the computer system is a portable computing system such as a notebook computer, a palm or other hand-held computer, a personal digital assistant, a telephone or other electronic computing system that may also incorporate communications features that provides for telephony, enhanced telephony, messaging and information services.
  • the computer system may also be, for example, a desktop computer, a network computer, a midrange computer or a mainframe computer.
  • the computer system is able to be connected to a network, such as the Internet by either a wired link or wireless link.
  • the computer system may be a stand-alone system or part of a network such as a local-area network (LAN) or a wide-area network (WAN). Therefore, in general, the present invention is preferably executed in a computer system that performs computing tasks such as manipulating data in storage that is accessible to the computer system.
  • the computer system includes at least one output device and at least one input device.

Abstract

La présente invention a trait à un procédé permettant : (1) à un donneur de sang d'utiliser une couche leucocytaire d'un prélèvement sanguin pour réaliser une transplantation autologue et/ou allogénique de certains constituants au sein de la couche leucocytaire ; (2) la séparation d'un prélèvement sanguin en parties constitutives, comprenant au moins deux prélèvements, dans lequel un premier prélèvement est dirigé vers un traitement autologue du donneur de sang ou un membre de la famille du donneur (un traitement allogénique), et l'autre prélèvement est dirigé vers un traitement allogénique de maladies ou la création d'un organe pour la population en général (non membres de la famille). Des prélèvements sanguins peuvent être soumis à la cryopréservation préalablement à l'utilisation dans la présente invention. En outre, les cellules soumises à la cryopréservation peuvent être remises à un chercheur en tant que source de matériau biologique non controversable (cellules souches et autres cellules). Evidemment, les procédés de la présente invention encouragent également des individus à stocker leurs propres cellules pour être utilisées dans un avenir proche ou grâce à des progrès techniques futurs et à la préservation actuelle pour la technologie de demain. Dans un mode de réalisation, les prélèvements sanguins sont : (1) séparés en constituants de la couche leucocytaire et notamment, en cellules souches et/ou progéniteurs ; (2) soumis à une analyse génétique pour évaluer la prédisposition génétique à la maladie dans l'historique de la famille du donneur ; et (3) sont réservés pour l'utilisation par un membre de la famille du donneur au cas où le membre de la famille contracte une maladie correspondant à l'analyse génétique.
PCT/US2003/006317 2002-03-05 2003-03-03 Double don de sang et procédé WO2003075789A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003219966A AU2003219966A1 (en) 2002-03-05 2003-03-03 Dual blood donation plus method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US36212102P 2002-03-05 2002-03-05
US60/362,121 2002-03-05

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WO2003075789A2 true WO2003075789A2 (fr) 2003-09-18
WO2003075789A3 WO2003075789A3 (fr) 2004-06-24

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011127472A1 (fr) * 2010-04-09 2011-10-13 Fred Hutchinson Cancer Research Center Compositions et procédés pour fournir une fonction hématopoïétique
WO2011127470A1 (fr) * 2010-04-09 2011-10-13 Fred Hutchinson Cancer Research Center Compositions et procédés pour fournir une fonction hématopoïétique sans correspondance hla

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ADAMS M. ET AL.: 'Rapid freezing of whole blood or buffy coat samples for polymerase chain reaction and cell culture analysis: application to detection of human immunodeficiency virus in blood donor and recipient repositories' TRANSFUSION vol. 33, 1993, pages 504 - 508, XP002977150 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011127472A1 (fr) * 2010-04-09 2011-10-13 Fred Hutchinson Cancer Research Center Compositions et procédés pour fournir une fonction hématopoïétique
WO2011127470A1 (fr) * 2010-04-09 2011-10-13 Fred Hutchinson Cancer Research Center Compositions et procédés pour fournir une fonction hématopoïétique sans correspondance hla
EP3097917A1 (fr) * 2010-04-09 2016-11-30 Fred Hutchinson Cancer Research Center Compositions et procédés pour fournir une fonction hématopoïétique sans correspondance hla
EP3097916A1 (fr) * 2010-04-09 2016-11-30 Fred Hutchinson Cancer Research Center Compositions et procédés pour fournir une fonction hématopoïétique
EP3590520A1 (fr) * 2010-04-09 2020-01-08 Fred Hutchinson Cancer Research Center Compositions pour fournir une fonction hématopoïétique sans correspondance hla

Also Published As

Publication number Publication date
AU2003219966A8 (en) 2003-09-22
AU2003219966A1 (en) 2003-09-22
WO2003075789A3 (fr) 2004-06-24

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