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Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01221428
Recruitment Status : Unknown
Verified July 2010 by Qingdao University.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2010
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
Qingdao University

Tracking Information
First Submitted Date  ICMJE October 14, 2010
First Posted Date  ICMJE October 15, 2010
Last Update Posted Date October 15, 2010
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
the result of enteroscopy and pathological report [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
the clinical symptom (including stomachache,abdominal distention,bloody purulent stool) [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Official Title  ICMJE Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
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.
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Mesenchymal Stem Cells
  • Umbilical Cord
Intervention  ICMJE 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).
Other Name: Mesenchymal Stem Cells
Study Arms Experimental: umbilical cord mesenchymal stem cells
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: Biological: Umbilical Cord Mesenchymal Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01221428
Other Study ID Numbers  ICMJE MSCKJ004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
Study Sponsor  ICMJE Qingdao University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gang Zhao, MD The Affiliated Hospital of Medical College of Qingdao University
PRS Account Qingdao University
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP