Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Qingdao University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Mesenchymal Stem Cells; Ulcerative Colitis; Umbilical Cord

Treatments: Biological: Umbilical Cord Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01221428

MSCKJ004

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

umbilical cord mesenchymal stem cells

Experimental group

Description:

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.

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells