Back to resultsUmbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Primary Purpose
Ulcerative Colitis, Mesenchymal Stem Cells, Umbilical Cord
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Mesenchymal Stem Cells, Umbilical Cord
Eligibility Criteria
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
Sites / Locations
- Stem Cell Research Center of Medical School Hospital of Qingdao University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
umbilical cord mesenchymal stem cells
Arm 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.
Outcomes
Primary Outcome Measures
the result of enteroscopy and pathological report
Secondary Outcome Measures
the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01221428
Brief Title
Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Official Title
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Qingdao University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Mesenchymal Stem Cells, Umbilical Cord
Keywords
Ulcerative colitis, Mesenchymal Stem Cells, Umbilical Cord
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
umbilical cord mesenchymal stem cells
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cells
Other Intervention Name(s)
Mesenchymal Stem Cells
Intervention Description
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).
Primary Outcome Measure Information:
Title
the result of enteroscopy and pathological report
Time Frame
3 months
Secondary Outcome Measure Information:
Title
the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
Stem Cell Research Center of Medical School Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
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