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Pharmaceutical composition as well as therapeutic agent and application thereof

A technology of composition and therapeutic agent, which is applied in the field of biopharmaceuticals, can solve the problems of increased survival rate of fat transplantation, achieve good rejection effect, improve facial atrophy, and increase the effect of fat survival rate

Pending Publication Date: 2022-03-29
BEIJING AEGLESSTEM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some studies have shown that vascular stromal fraction (SVF)-assisted fat grafting can improve fat graft survival by approximately 35% in healthy individuals, but no reports have demonstrated similar increases in fat graft survival in patients with LoS

Method used

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  • Pharmaceutical composition as well as therapeutic agent and application thereof
  • Pharmaceutical composition as well as therapeutic agent and application thereof
  • Pharmaceutical composition as well as therapeutic agent and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The collection of embodiment 1 sample

[0045] In this study, 22 patients (female: 15; male: 7) with facial depression caused by scleroderma were selected, 8 patients received ADSCs-assisted fat grafting (experimental group), and 7 patients received vascular stromal component (SVF)-assisted fat grafting. (standard control group) and 7 cases of simple fat transplantation group (blank control group). The study followed the statement of the Helsinki Guidelines, which was approved by the Institutional Ethics Committee (JMLL20180902) and registered with the Chinese Clinical Trials Registry (ChiCTR1900025717).

[0046] Sample inclusion criteria:

[0047] (1) Patients with localized scleroderma diagnosed by dermatology;

[0048] (2) The localized scleroderma is in a stable stage;

[0049] (3) Facial depression deformity caused by localized scleroderma;

[0050] (4) Age 18-50;

[0051] (5) The subject or legal representative gave informed consent, volunteered to be tested,...

Embodiment 2

[0060] The collection of embodiment 2 granular fat

[0061] Adipose tissue comes from healthy volunteers. Before collection, the age and sex of the donors are recorded in detail, and their health status is known through routine physical examination. Serological tests for HBV, HCV, HIV and syphilis are required to be negative. On the morning of the day of collection, no food or water was fasted, and all biochemical items and routine blood tests were checked before entering the operating room.

[0062] The liposuction area is generally located in the abdomen, anesthetized with tumescent fluid, formula of tumescent fluid: 1000mL normal saline + 2% lidocaine 30mL + 1:1000 epinephrine 1mL + 5% sodium bicarbonate 10mL. Use a 20mL syringe to connect a small-caliber sharp suction needle (diameter mm), draw it back after entering the subcutaneous area, and form a negative pressure, reciprocating suction in a spoke or fan shape. After the suction is completed, the syringe is still inve...

Embodiment 3

[0064] Example 3 Isolation and cultivation of adipose-derived stem cells

[0065] 1. Isolation of somatic cells

[0066] (1) Add an equal volume of normal saline to wash the fat three times: transfer the upper layer of fat to 50ml sterile centrifuge tubes, about 20ml per tube, add saline to 40ml per tube, centrifuge at room temperature in a horizontal centrifuge, 500 rpm, 5 minutes .

[0067] (2) Add 10ml of collagenase digestion solution to each tube, supplement with saline to 35ml per tube, shake and digest at 37°C for 15-35 minutes, until the fat is digested into a uniform turbid liquid, and no obvious lumps are visible.

[0068] (3) Use a 100 μm filter to filter into a 50ml sterile centrifuge tube, and rinse the original centrifuge tube and filter with normal saline. Use DPBS or normal saline to make up the filtered liquid to 40ml per tube, and centrifuge in a horizontal centrifuge at room temperature at 1500 rpm for 10 minutes.

[0069] (4) Suspend the cells with the c...

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Abstract

The pharmaceutical composition comprises a component A and a component B. The component A is an adipose-derived stem cell population, the component B is granular fat, and the cell density in the adipose-derived stem cell population is 1 * 10 < 5 >-1 * 10 < 8 > / mL. The volume ratio of the component A to the component B is 1: (10-30). The invention further provides a therapeutic agent for treating scleroderma and application of the therapeutic agent. The pharmaceutical composition provided by the invention is safe, effective, low in cost and good in rejection reaction effect, and a therapeutic agent containing the pharmaceutical composition is effective and safe in the aspect of improving graft retention of facial atrophy of LoS patients and is superior to simple fat transplantation or SVF-assisted fat transplantation. In addition, the therapeutic agent provided by the invention can more effectively improve the fat survival rate under the condition that blood perfusion is not obviously changed.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a pharmaceutical composition and its therapeutic agent and application. Background technique [0002] Scleroderma is a chronic disease characterized by excessive deposition of collagen in the skin or other organs. Scleroderma can be localized or systemic. Localized forms of scleroderma are disabling, but not tending to be fatal. The systemic form of scleroderma manifests as diffuse scleroderma or systemic sclerosis, and the disease can be fatal due to destruction of the heart, kidneys, lungs, or intestines. The three types of scleroderma are diffuse scleroderma Diffuse cutaneous systemic scleroderma, limited cutaneous scleroderma limited cutaneous scleroderma (commonly known as CREST syndrome is also systemic), and focal scleroderma Localized scleroderma, namely Morphea / Linear scleroderma (which is confined to the skin). Diffuse scleroderma is the most severe form,...

Claims

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Application Information

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IPC IPC(8): A61K35/35A61P17/00A61K35/28
CPCA61K35/28A61K35/35A61P17/00A61K2300/00A61L27/38C12N5/06A61P37/02A61L27/50A61K9/08
Inventor 叶伟亮杨跃梅李立杰
Owner BEIJING AEGLESSTEM TECH CO LTD
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