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Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

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.
 
ClinicalTrials.gov Identifier: NCT02445547
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
Shaanxi Provincial People's Hospital
Information provided by (Responsible Party):
Fuzhou General Hospital

Study Description
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Brief Summary:
Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: UC-MSCs by peripheral intravenous infusion Drug: received hormone maintenance therapy Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial
Study Start Date : June 2012
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UC-MSCs
UC-MSCs by peripheral intravenous infusion
 Other: UC-MSCs by peripheral intravenous infusion
Active Comparator: control
received hormone maintenance therapy
 Drug: received hormone maintenance therapy


Outcome Measures
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Primary Outcome Measures :
  1. Crohn's disease activity index [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Harvey-Bradshaw index [ Time Frame: 12 months ]
  2. Corticosteroid dosage [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • above 18 years of age
  • moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450)
  • had received hormone maintenance therapy for more than 6 months

Exclusion Criteria:

  • active tuberculosis
  • malignancy
  • HIV
  • syphilis
  • hepatitis B
  • hepatitis C
Contacts and Locations
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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): NCT02445547


Locations
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China, Shaanxi
Shaanxi Provincial People's Hospital
Xi Ail, Shaanxi, China, 111111
Sponsors and Collaborators
Fuzhou General Hospital
Shaanxi Provincial People's Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT02445547    
Other Study ID Numbers: UCMSC-CD
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs