Ulcerative Colitis Clinical Trial
Official title:
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Verified date | July 2010 |
Source | Qingdao University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Stem Cell Research Center of Medical School Hospital of Qingdao University | Qingdao | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qingdao University |
China,
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 |
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