Cell-based biological drug for allogeneic adoptive cellular immunotherapy for hematological diseases and preparation method

A technology of cellular immunity and blood system, which is applied in the field of cell-based biomedicine and preparation of allogeneic adoptive cellular immunotherapy for blood system diseases, can solve the problems of high mortality, poor quality of life of patients, and few applications, and achieve hematopoiesis Improvement of function, good tolerance of patients, and recovery of physical strength

Active Publication Date: 2016-08-03
SHANGHAI XINGHUA BIOMEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0027] (3) Interferon: It can directly inhibit the proliferation of tumor cells, and can inhibit leukemia clones. It is rarely used clinically at present
[0055] At present, there is a lack of good therapeutic drugs for MDS. The effective rate (improvement rate) of various treatment methods is about 30%, and the effect is not very satisfactory. The quality of life of patients is poor.
Allogeneic hematopoietic stem cell transplantation is currently the only therapy that can cure MDS, but there are many restrictions. At the same time, because MDS is mostly elderly patients, transplantation-related mortality is high

Method used

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  • Cell-based biological drug for allogeneic adoptive cellular immunotherapy for hematological diseases and preparation method
  • Cell-based biological drug for allogeneic adoptive cellular immunotherapy for hematological diseases and preparation method
  • Cell-based biological drug for allogeneic adoptive cellular immunotherapy for hematological diseases and preparation method

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preparation example Construction

[0084] The invention provides a medicine for treating MDS and a preparation method thereof, the preparation steps comprising:

[0085] Step 1, co-cultivating immune cells and antigens in a liquid cell culture medium in a culture container, so as to obtain specific immune cell cultures with anti-corresponding antigens;

[0086] Step 2, isolating cellular biopharmaceuticals with an immune response from the culture obtained in step 1;

[0087] Wherein, in addition to immune cells, the liquid cell culture medium also includes components a)~e):

[0088] a) Cell mitogens: any one or more of concanavalin, phytohemagglutinin, pokeweed, lipopolysaccharide, dextran, and anti-CD3 antibody.

[0089] b) Antigen: The antigen is an abnormal clone of hematopoietic stem cells, and can be an antigen derived from allogeneic, heterogeneous, or self.

[0090] c) Exogenous superantigens, and / or endogenous superantigens: such as bacterial endotoxin, endogenous superantigens: such as any one or sev...

Embodiment 1

[0105] Allogeneic mononuclear cells are co-cultured with specific antigens (abnormal clones of hematopoietic stem cells) in a liquid medium, which also includes concanavalin, exogenous superantigens, lymphokines, and immune adjuvants, among which , the amount of concanavalin in the medium is 1 μg / L; the amount of exogenous superantigen (Pseudomonas aeruginosa toxin) in the medium is 5 μg / L; the amount of lymphokine (interleukin II) in the medium is 1000u / L; the dosage of immune adjuvant (5% Tween-80) was 0.1mL / L.

[0106] The ratio of T lymphocytes to specific antigen (Raji (Burkitt's lymphoma cells)) is 5:1 (cell number ratio).

[0107] The T lymphocytes are co-cultured with specific antigens for 30 days to obtain specific immune cell cultures with anti-corresponding antigens.

[0108] Cells with an immune response, mainly cytotoxic T lymphocytes, are isolated from the culture.

Embodiment 2

[0110] Allogeneic mononuclear cells (genetically modified T lymphocytes) are co-cultured with specific antigens (abnormal clones of hematopoietic stem cells) in a liquid medium that also includes phytohemagglutinin, endogenous superantigens , lymphokine, immune adjuvant, among which, the dosage of phytohemagglutinin (PHA) in the culture medium is 5 μg / L; the dosage of endogenous superantigen (Pseudomonas aeruginosa toxin) in the culture medium is 1 μg / L; (Interferon) in the culture medium at a dosage of 1000u / L; immune adjuvant (5% Tween-80) at a dosage of 0.1mL / L.

[0111] The ratio of T lymphocytes to specific antigen (MOLT-4 (acute lymphoblastic leukemia cells)) is 50:1 (cell number ratio).

[0112] Co-cultivate T lymphocytes with specific antigens for 90 days to obtain specific immune cell cultures against corresponding antigens.

[0113] Cells with an immune response, mainly cytotoxic T lymphocytes, are isolated from the culture.

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Abstract

The invention provides a cell biological drug and a biological preparation for allogeneic adoptive cellular immunotherapy of blood system diseases such as MDS (myelodysplastic syndromes) or leukemia, and a preparation method. The preparation method of the cell biological drug consists of: subjecting an immune cell and an antigen to co-culture in a liquid cell culture medium in a culture container so as to obtain a specific immune cell culture resisting the corresponding antigen; and separating a cell biological drug with an immune response from the obtained culture. The immune cell can be an allogeneic cell, has no allogeneic rejection reaction in use, and has high security. After treatment of MDS, hematopoietic functions in bone marrow puncture, bone marrow biopsy and bone marrow stem cell culture are all significantly improved. In a treatment process, patients have good tolerance. In the invention, MDS is treated by means of a brand new etiological treatment strategy of improving organism immunity, and the hematopoietic function in patients is effectively restored. The cell biological drug provided in the invention has good prospects for treatment of other hematopoietic stem cell malignant cloning diseases including leukemia.

Description

technical field [0001] The invention relates to a medicine for heterogeneous adoptive cellular immunotherapy for blood system diseases, in particular to a biological medicine for adoptive cellular immunotherapy for MDS or leukemia, and a preparation method thereof. Background technique [0002] At present, it is believed that a variety of blood system diseases, including red blood cell diseases, such as aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH), etc.; white blood cell diseases, such as various leukemias, malignant lymphoma, malignant lympho-reticulocyte hyperplasia disease, plasma cell disease, histiocytosis, myelodysplastic syndrome, myeloproliferative disease (polycythemia vera, essential thrombocythemia, myelofibrosis), etc. are all derived from hematopoietic stem cells or pluripotent stem cells Clonal STDs. [0003] Representative is myelodysplastic syndrome (MyelodysplasticSyndromes, MDS). MDS is a heterogeneous clonal venereal disease originating fro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/00C12N5/078C12N5/0783C12N5/0786A61P7/00A61P7/06A61P35/00A61P35/02
Inventor 刘华
Owner SHANGHAI XINGHUA BIOMEDICAL TECH
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