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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01221428
Other study ID # MSCKJ004
Secondary ID
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


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
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