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Pharmaceutical composition for treating Crohn's disease and preparation method thereof

A technology for Crohn's disease and a composition is applied in the field of pharmaceutical compositions for treating Crohn's disease and their preparation, which can solve the problems of poor tolerance and easy rejection, achieve better immunosuppressive function, and promote CD healing. , the effect of reducing complications

Pending Publication Date: 2022-03-01
SHANGHAI EAST HOSPITAL EAST HOSPITAL TONGJI UNIV SCHOOL OF MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the use of fat or bone marrow MSCs is prone to rejection and is not well tolerated

Method used

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  • Pharmaceutical composition for treating Crohn's disease and preparation method thereof
  • Pharmaceutical composition for treating Crohn's disease and preparation method thereof
  • Pharmaceutical composition for treating Crohn's disease and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] An injection for treating moderate to severe Crohn's disease, comprising umbilical cord mesenchymal stem cells and physiological saline containing 5% (volume fraction) albumin.

[0040]The method for extracting umbilical cord mesenchymal stem cells comprises the following steps: ligating both ends of fresh umbilical cord tissue, soaking in a sterile bottle containing physiological saline, and transporting it to a laboratory at 2-8°C; Open the bottle, discard the preservation solution in the bottle, add physiological saline (just immerse the umbilical cord) into the bottle, shake and wash. After discarding the saline, pour the umbilical cord into a sterile 100mm Petri dish and spray the surface of the umbilical cord with 75% ethanol solution. After cleaning the umbilical cord after alcohol spraying with normal saline for 2-3 times, add normal saline to the petri dish, take sterile scissors and divide the umbilical cord into 3-4cm segments, and wash away the blood; put th...

Embodiment 2

[0043] Animal experiment:

[0044] 1. Experimental method:

[0045] Thirty specific pathogen-free (SPF) female Sprague-Dawley rats (6-8 weeks), purchased from Shanghai Slack Experimental Animal Co., Ltd., were adaptively fed for one week before the experiment, and the feeding conditions were: temperature 22±2°C, humidity 55±5%, normal diet. After fasting for 24 hours on D0 day, they were randomly divided into three groups (n=10 / group): control group, trinitrobenzenesulfonic acid (TNBS) group, and TNBS+stem cell group.

[0046] On D1 day, all rats were anesthetized by intraperitoneal injection of 3% pentobarbital sodium 1ml / kg body weight.

[0047] TNBS group: Mix 5% TNBS and absolute ethanol at a volume ratio of 1:1 to make a 50% ethanol solution containing 2.5 mg / ml TNBS, and enema at a distance of 8-10 cm from the anus according to the standard of 100 mg / kg body weight of the mixed solution After filling, pull out the hose and keep the rat upside down for about 30 seconds...

Embodiment 3

[0073] Different injection methods and doses are used to treat Crohn's disease.

[0074] Patients with Crohn's disease were screened and randomly divided into five groups of 4 people. Different drugs and administration methods were used to observe the effectiveness and safety of clinical remission of moderate to severe Crohn's disease.

[0075] The inclusion criteria of the subjects are as follows:

[0076] 1) At the time of randomization, subjects between the ages of 18-75 (including the boundary value), male or female,

[0077] 2) At the time of randomization, records showed that subjects with a diagnosis of ileal, colonic or ileocolic Crohn's disease had been present for at least 3 months.

[0078] 3) Currently suffering from Crohn's disease and the Crohn's disease activity index (CDAI) score ≥ 220 and ≤ 450 points.

[0079] 4) During the screening period, the endoscopic confirmatory examination of active disease confirms that the subject has evidence of active inflammati...

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Abstract

The invention discloses a pharmaceutical composition for treating Crohn's disease and a preparation method thereof. The pharmaceutical composition comprises umbilical cord mesenchymal stem cells and a pharmaceutically acceptable carrier. The umbilical cord mesenchymal stem cell is easy to obtain and amplify, has no immunogenicity, has the functions of immunoregulation and tissue repair, and can promote CD healing. The umbilical cord mesenchymal stem cells prepared by the invention have very strong immunoregulation and immunosuppression potentials, are extremely low in immunogenicity, and have no heterologous rejection symptom in clinical application.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a pharmaceutical composition for treating Crohn's disease and a preparation method thereof. Background technique [0002] Crohn's disease (CD) is a chronic inflammatory granulomatous disease of the gastrointestinal tract whose etiology is still unclear. The peak age of onset is 18-35 years old, and males are slightly higher than females (1.5:1). Lesions can affect any part of the digestive tract, and are more common in the terminal ileum and adjacent colon. They are distributed segmentally or skippingly, and the invasion depth can reach the entire thickness of the intestinal wall. Repeated chronic inflammation can cause thickening of the intestinal wall and fibrosis, and intestinal lumen narrowing. Clinically, it is characterized by abdominal pain, diarrhea, weight loss, abdominal mass, fistula formation, and intestinal obstruction. It may be accompanied by systemic manifestations such ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N5/0775A61K35/28A61P1/00
CPCC12N5/0668A61K35/28A61P1/00C12N2509/10
Inventor 钟岚王炜赵广西孙钦娟李珊杨玉琛胡淼杨小青
Owner SHANGHAI EAST HOSPITAL EAST HOSPITAL TONGJI UNIV SCHOOL OF MEDICINE
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