Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Sponsor

Qingdao University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01221428

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Mesenchymal Stem Cells Umbilical Cord	Biological: Umbilical Cord Mesenchymal Stem Cells	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Umbilical Cord Mesenchymal Stem Cells Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(210/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(110/7). Other Names: Mesenchymal Stem Cells

Arm

Intervention/Treatment

Experimental: 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.

Biological: Umbilical Cord Mesenchymal Stem Cells

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).

Other Names:

Mesenchymal Stem Cells

Outcome Measures

Primary Outcome Measures

the result of enteroscopy and pathological report [3 months]

Secondary Outcome Measures

the clinical symptom (including stomachache,abdominal distention,bloody purulent stool) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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