Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Qingdao University50 enrolled

Overview

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract．Nowadays，etiology and pathogenesis of UC have been unclear．Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract，which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis Mesenchymal Stem Cells Umbilical Cord

Interventions

Umbilical Cord Mesenchymal Stem CellsBIOLOGICAL

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(2\*10/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(1\*10/7).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, 18 years of age or older. * Ulcerative colitis described according to usual criteria. * Refractoriness Ulcerative colitis or unefficient by using other therapy * Signed informed consent form. Exclusion Criteria: * History of neoplasm or hematological disease * Uncontrolled high blood pressure (\>180/110) * Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30% * Malignant ventricular arrythmia * Deep venous thrombosis during the last 3 months * Active bacterial infection * Body mass index \> 35 Kg/m2 * Stroke or myocardial infarction during the last 3 months

Locations (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China

Outcomes

Primary Outcomes

the result of enteroscopy and pathological report

Time frame: 3 months

Secondary Outcomes

the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)

Time frame: 3 months

Data from ClinicalTrials.gov

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