Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Phase 1

• Conditions: Ulcerative Colitis; Mesenchymal Stem Cells; Umbilical Cord
• Interventions: Biological: Umbilical Cord Mesenchymal Stem Cells

• Registration Number: NCT01221428
• Lead Sponsor: Qingdao University

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.

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-09
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-14
• Last Update Submitted: 2010-10-14
• Study First Posted: 2010-10-15
• Last Update Posted: 2010-10-15
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord mesenchymal stem cells	Umbilical Cord Mesenchymal Stem Cells	Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells,one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery.

Primary Outcome Measures

Name	Time	Method
the result of enteroscopy and pathological report	3 months

Secondary Outcome Measures

Name	Time	Method
the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)	3 months

Trial Locations

Locations (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China