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Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Qingdao University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221428
First Posted: October 15, 2010
Last Update Posted: October 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Qingdao University
  Purpose
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

Condition Intervention Phase
Ulcerative Colitis Mesenchymal Stem Cells Umbilical Cord Biological: Umbilical Cord Mesenchymal Stem Cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Qingdao University:

Primary Outcome Measures:
  • the result of enteroscopy and pathological report [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • the clinical symptom (including stomachache,abdominal distention,bloody purulent stool) [ Time Frame: 3 months ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221428


Locations
China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Sponsors and Collaborators
Qingdao University
Investigators
Study Director: Gang Zhao, MD The Affiliated Hospital of Medical College of Qingdao University
  More Information

Responsible Party: Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01221428     History of Changes
Other Study ID Numbers: MSCKJ004
First Submitted: October 14, 2010
First Posted: October 15, 2010
Last Update Posted: October 15, 2010
Last Verified: July 2010

Keywords provided by Qingdao University:
Ulcerative colitis
Mesenchymal Stem Cells
Umbilical Cord

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases