Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Qingdao University1 site in 1 country50 target enrollmentSeptember 2010

ConditionsUlcerative Colitis Mesenchymal Stem Cells Umbilical Cord

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Qingdao University
Enrollment: 50
Locations: 1
Primary Endpoint: the result of enteroscopy and pathological report
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

December 2012

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Qingdao University

Eligibility Criteria

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