Umbilical cord mesenchymal stem cell injection for treating systemic sclerosis accompanied by acroscleriasis and preparation method thereof

A systemic sclerosis and stromal cell technology, applied in systemic sclerosis, umbilical cord mesenchymal stem cell injection and its preparation field, can solve the problem of immature and unsuitable skin mesenchymal stem cell preparation and quality control. Clinical application and other issues, to achieve the effect of relieving acrosclerosis symptoms, long-term validity, and easy to use

Inactive Publication Date: 2019-08-02
COBAXER BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

CN108451981A discloses an application of using skin mesenchymal stem cells to treat systemic sclerosis, but the preparation and quality control of skin mesenchymal stem cells are immature and not suitable for clinical application at this stage

Method used

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  • Umbilical cord mesenchymal stem cell injection for treating systemic sclerosis accompanied by acroscleriasis and preparation method thereof
  • Umbilical cord mesenchymal stem cell injection for treating systemic sclerosis accompanied by acroscleriasis and preparation method thereof
  • Umbilical cord mesenchymal stem cell injection for treating systemic sclerosis accompanied by acroscleriasis and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A preparation method for umbilical cord mesenchymal stem cell injection, comprising the steps of:

[0045] S1. Prepare umbilical cord mesenchymal stem cells. The specific operation is as follows: S11. Collect umbilical cord specimens and perform cell separation within 48 hours;

[0046] S12. Use the tissue block inoculation method to isolate and cultivate primary cells, and use serum-free and xeno-free medium (StemMACS) for primary cell culture and subsequent cell expansion. TM MSC Expansion Media Kit XF, Miltenyi Biotec);

[0047] S13. Harvest the primary cells P0, subculture and expand to P1, and the cell passage density is 6000cell / cm2 , Harvest the cells in about 3 days; continue to subculture and expand to P2, harvest the P2 generation cells in about 3 days, and perform quality inspection. The inspection items include: cell viability, cell phenotype, cell differentiation potential, biological function, microorganisms, mycoplasma, Viruses and endotoxins; cells are ...

Embodiment 2

[0067] Preclinical research on the treatment of scleroderma mouse models with umbilical cord mesenchymal stem cells, the specific operations are as follows:

[0068] Establishment of scleroderma mouse model: (1) 30 female 6-week-old BALB / c mice were randomly divided into three groups: A, B, and C, respectively SSc model group, SSc model + mesenchymal stem cell treatment group, PBS control group; (2) Select the skin on the back of the mouse near the base of the tail, and remove the local hair of 1.5cm×1.5cm with depilatory cream; A, B two groups of mice were subcutaneously injected with 100 μL 1mg / ml bleomycin on the back, C group mice 100 μL PBS was subcutaneously injected on the back, once a day for 4 consecutive weeks; (3) Observe the changes of the skin at the injection site. model successfully.

[0069] Tail vein injection of umbilical cord mesenchymal stem cells to treat scleroderma mouse model: (1) After successful modeling, the umbilical cord mesenchymal stem cells pre...

Embodiment 3

[0073] Clinical research on the treatment of systemic sclerosis with umbilical cord mesenchymal stem cell injection, the specific operations are as follows:

[0074] 1. From May to November 2015, 42 outpatients and inpatients with systemic sclerosis were enrolled; the volunteers were randomly divided into two groups: traditional treatment group and combined treatment group. The general condition of the patients is shown in Table 2 below. Among them, MRSS: modified Rodnan score; dcSSc: diffuse scleroderma; lcSSc: localized scleroderma; ESSG index: activity index of European scleroderma study group. Through the statistics of gender, age, disease duration, MRSS, dcSSC / lcSSc and ESSG index and other indicators, the results showed that there was no significant difference between the traditional treatment group and the combined treatment group.

[0075] 2. Inclusion criteria: (1) Patients who understand and sign the informed consent form; (2) have not used any blood products (excep...

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Abstract

The invention discloses an umbilical cord mesenchymal stem cell injection for treating systemic sclerosis accompanied by acroscleriasis, which comprises an active ingredient umbilical cord mesenchymalstem cells and an auxiliary material; the auxiliary material comprises a sodium lactate Ringer injection, a ProFreeze cell cryopreservation solution, dimethyl sulfoxide and human serum albumin; the number of umbilical cord mesenchymal stem cells in 1 mL of injection is 0.2*10<7>. In the umbilical cord mesenchymal stem cell injection, the volume fraction of the sodium lactate Ringer injection is 45 to 55%, the volume fraction of the ProFreeze cell cryopreservation solution is 40 to 45%, the volume fraction of the dimethyl sulfoxide is 5 to 10%, and the mass fraction of the human serum albuminis 2.5 to 7.5%. The results of animal trials and clinical trials indicate that the umbilical cord mesenchymal stem cell injection of the invention can ameliorate the systemic sclerosis accompanied byacroscleriasis and has no stem cell-related adverse reactions. The umbilical cord mesenchymal stem cell injection has the advantages that the preparation process is simple, the quality control is strict, and a good clinical application prospect is realized.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to an umbilical cord mesenchymal stem cell injection, a preparation method thereof, and an application thereof in systemic sclerosis. Background technique [0002] Systemic sclerosis (SSc) is an autoimmune disease with complex etiology, characterized by vascular lesions and excessive deposition of extracellular matrix, which can cause fibrosis of the skin and internal organs, and eventually lead to multiple organ dysfunction . Systemic sclerosis, commonly known as scleroderma, can be divided into two main subtypes according to the degree of skin involvement: localized scleroderma and diffuse scleroderma, and the 5-year survival rate of patients with diffuse SSc is only 35-45% %. Systemic sclerosis is a chronic disease with insidious onset and long course, which seriously affects the quality of life of patients and brings huge economic burden to families and society...

Claims

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Application Information

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IPC IPC(8): A61K35/28A61K9/08A61P17/00A61P37/02C12N5/0775
CPCA61K9/0019A61K9/08A61K35/28A61P17/00A61P37/02C12N5/0665
Inventor 陈勇军左凤琼杨莉黄雨
Owner COBAXER BIOTECH
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