Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ulcerative Colitis, Mesenchymal Stem Cells, Umbilical Cord

Intervention / Treatment
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* Biological: Umbilical Cord Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord mesenchymal stem cells<br>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. | Biological: Umbilical Cord Mesenchymal Stem Cells<br>* 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).<br>* Other names: Mesenchymal Stem Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the result of enteroscopy and pathological report |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the clinical symptom (including stomachache,abdominal distention,bloody purulent stool) |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, Mesenchymal Stem Cells, Umbilical Cord