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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01221428 |
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Date of registration:
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14/10/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
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Scientific title:
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Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01221428 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Gang Zhao, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Affiliated Hospital of Medical College of Qingdao University |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Mesenchymal Stem Cells
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Umbilical Cord
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Intervention(s)
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Biological: Umbilical Cord Mesenchymal Stem Cells
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Primary Outcome(s)
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the result of enteroscopy and pathological report
[Time Frame: 3 months]
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Secondary Outcome(s)
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the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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