Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01221428
• Other study ID #: MSCKJ004
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 14, 2010
• Last updated: October 14, 2010
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2010
• Source: Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Mesenchymal Stem Cells
• Ulcer
• Ulcerative Colitis
• Umbilical Cord

Intervention

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).

Locations

Country	Name	City	State
China	Stem Cell Research Center of Medical School Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the result of enteroscopy and pathological report		3 months	No
Secondary	the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)		3 months	No