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Composition for stabilizing survival of transplanted hematopoietic stem cell, kit for obtaining the composition, method of stabilizing survival of transplanted hematopoietic stem cell, human monoclonal antibody or human polyclonal antibody and method of pRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Lymphokine, InterleukinComposition for stabilizing survival of transplanted hematopoietic stem cell, kit for obtaining the composition, method of stabilizing survival of transplanted hematopoietic stem cell, human monoclonal antibody or human polyclonal antibody and method of p description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070025961, Composition for stabilizing survival of transplanted hematopoietic stem cell, kit for obtaining the composition, method of stabilizing survival of transplanted hematopoietic stem cell, human monoclonal antibody or human polyclonal antibody and method of p. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] The present invention relates to a composition for promoting survival of transplanted hematopoietic stem cells that is employed for improving survival failure, which is especially a problem in transplantation of hematopoietic stem cells, disadvantage of delaying production of antibodies or immunocompromised condition, or for decreasing a risk for various types of infectious disease or relapse of cancers after survival, a kit for obtaining the composition, a method for promoting survival of the transplanted hematopoietic stem cells, and a human monoclonal antibody which is employed in therapy for various human diseases and a method for producing the human monoclonal antibodies or human polyclonal antibodies. TECHNICAL BACKGROUND [0002] Because cell transplanted patients, especially hematopoietic stem cell transplanted patients are in danger of a crisis of various types of infection or relapse of cancers, a lot of studies for corresponding to them have been carried out. Sekine who is one of the inventors of the present invention previously reported that lymphocytes could be propagated by using immobilized anti-CD3 antibodies and interleukin 2, and the propagated autologous lymphocytes thus had an antineoplastic effect (JP 03-80076 A1). [0003] Besides, it has already been reported that the autologous lymphocytes propagated with the anti-CD3 antibodies and interleukin 2 are effective to virus infections in congenital immunodeficiency patients [Kimiya ITO, Teruaki SEKINE; IGAKU NO AYUMI, Volume 181, NO. 6, Page 426 to 427 (1997)]. Furthermore, in a field for hematopoietic stem cell transplantation, when some of major HLA which consist of four loci, A, B, C and DR and further loci DQ and DP are matched between a patient and donor, a bone marrow transplantation or a blood transfusion can be carried out. [0004] Moreover, since Kohler and Milstein developed the cell fusion technique in 1975, various monoclonal antibodies are produced and applied to an analysis, measurement, a diagnosis and therapy. Almost of the monoclonal antibodies reported by now are derived from animals, and especially mouse-derived, and obtained by immortalizing antibody producing cells from immunized animals by cell fusion. The monoclonal antibody is considered as an attractive drug carrier because it is uniform in an antibody subclass, is higher antigen specificity and has very small clearance, so that new Drug Delivery System (DDS) with a monoclonal antibody has been investigated. DISCLOSURE OF THE INVETION PROBLEMS TO BE RESOLVED BY THE INVENTION [0005] However, even if autologous lymphocytes propagated with anti-CD3 antibodies and interleukin 2 are effective to an antitumor effect or a viral infection in a congenital immunodeficiency patient, it does not mean a stage in which satisfactory effect can be necessarily expected with it. Although a bone marrow transplantation or a blood transfusion is carried out when some of major HLA loci are matched, a risk to develop a fatal side effect in a bone marrow transplantation or DLT treated patient according to mismatch in rest of HLA, namely Post Transfusion-Graft versus Host Disease (hereinafter, abbreviated as "PT-GVHD") is still existed. [0006] Furthermore, also in the monoclonal antibodies, when animal-derived antibodies which are obtained by sensitizing antigens to the animals as described above are administrated to humans, it is difficult to use them regularly as a remedy because the antibodies themselves indicate immunogenicity. In order to avoid the immunogenicity, a method that the antigenicity can be decreased by means of a method such as to fragmentize the monoclonal antibodies originated from animals to Fab2, or F(ab)'2, to chimerarize with human antibodies, or to humanize, or a method that humanized antibody cell lines are established with a antibody producing cell obtained from the real patient or human lymphocytes sensitized in vitro and so on are examined. [0007] However, because the respective methods have problems in the points of a residual of antigenicity, difficulty of establishing human antibody producing lines, decrease of capacity of antibody production during cell culture and so on, it is strongly desired to develop a method for establishing human antibodies easily and efficiently by the other procedure. Besides, the polyclonal antibody also has problems similar to in the monoclonal antibody, so that various methods are examined in order to medicate them to human safely and efficiently. A Means for Resolving the Problem [0008] The inventors in the present invention succeeded in preparing HLA identical activated lymphocytes possible to improve survival of hepatocytes to a transplanted patient with that cells whose HLA is identical to transplanted hematopoietic stem cells are stimulated and propagated by interleukin 2 and anti-CD3 antibodies and then they are given to the patient, resulting from diligent studies for the purpose of developing a medicament and a method for improving the survival of transplanted cells, especially hematopoietic stem cells. [0009] Furthermore, the inventors succeeded in producing human monoclonal antibodies efficiently by sensitizing antigens as giving human activated lymphocytes to immunocompromised mouse in which human hematopoietic stem cells are transplanted. Namely, if an embodiment of a primary invention is mentioned, an invention according to claim 1 relates to a composition for stabilizing survival of transplanted hematopoietic stem cell whose main component is HLA identical lymphocytes produced by separating and collecting them after propagating and activating HLA identical lymphocytes in mononuclear cells separated from peripheral blood or umbilical cord blood. [0010] Besides, an invention according to claim 4 relates to a method for producing a composition for stabilizing survival of transplanted hematopoietic stem cells, comprising a process for separating mononuclear cells from peripheral blood or umbilical cord blood including HLA identical lymphocytes, a process for propagating and activating the HLA identical lymphocytes in the separated mononuclear cells, and a process for separating the propagated and activated HLA identical lymphocytes and preparing remedy having them as a main component. [0011] Furthermore, an invention according to claim 7 relates to a kit for obtaining the composition for stabilizing survival of transplanted hematopoietic stem cells comprising an implement for separating HLA identical lymphocytes from peripheral blood or umbilical blood, an implement for propagation and activation comprising either/both culture medium including interleukin 2 or/and an anti-CD3 antibody solidified flask, and an implement for taking out the HLA identical lymphocytes cultured by the implement for propagation and activation. Moreover, an invention according to claim 8 relates to human monoclonal antibody producing cell lines collected by a method such that HLA identical activated lymphocytes are given before or after transplanting to mammals, antigens are sensitized after stabilization of survival, and the antigen sensitized lymphocytes are established or separated from the mammals, or a method for gene separation or expression, etc. [0012] Furthermore, an invention according to claim 9 relates to a method for producing human monoclonal antibody producing cell lines collected by a method that human hematopoietic stem cells are transplanted to mammals which are severe combined immunodeficiency mice such as SCID mice, and further antigens are sensitized after the survival by giving HLA identical activated lymphocytes before or after the transplantation, the antigen sensitized lymphocytes are established or separated from the mammals, or a method for gene separation or expression, etc. EFFECT OF THE INVENTION [0013] As mentioned above, the present invention relates to remedy for preventing survival failure and promoting survival after transplantation of hematopoietic stem cells characterized that it includes HLA identical activated lymphocytes whose main component is HLA identical propagated/activated lymphocytes or propagated donor lymphocytes, so that it can be used widely for promoting the survival of the stem cells at transplantation. As well as it can be used for promoting the survival of the stem cells, it can also be used for promoting survival of various internal organs, and antibodies which have specificity and high binding affinity with the antigen can be obtained by transplanting human hematopoietic stem cells to mammals and giving HLA identical propagated/activated lymphocytes and immunogens. Besides, the human monoclonal antibodies can be produced efficiently by using the cells producing the antibodies. Moreover, it can be used widely as screening of the remedy such as anti-virus medicament, anti-cancer medicament and anti-hypertension medicament by transplanting the human hematopoietic stem cells and using the mammals which are transplanted with HLA-identical propagated/activated lymphocytes. BEST MODE FOR CARRYING OUT THE INVENTION [0014] Hereinafter, concrete contents of the invention are explained. [HLA Identical] [0015] HLA identical in the present invention is to match in not less than three loci among several primary HLA components such as 4 loci A, B, C, DR, and further DQ and DP. [Collecting Lymphocytes] Continue reading about Composition for stabilizing survival of transplanted hematopoietic stem cell, kit for obtaining the composition, method of stabilizing survival of transplanted hematopoietic stem cell, human monoclonal antibody or human polyclonal antibody and method of p... 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