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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

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE May 15, 2015
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)		 Crohn's disease activity index [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)		 Percentage of Participants With HBV DNA < 500 Copies/mL at Week 4 [ Time Frame: week 4 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Harvey-Bradshaw index [ Time Frame: 12 months ]
  • Corticosteroid dosage [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12, 24, and 48 [ Time Frame: week 12,24, and 48 ]
  • Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 4, 12, 24, and 48 [ Time Frame: week 4,12,24, and 48 ]
  • Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 4, 12, 24, and 48 [ Time Frame: week 4,12,24, and 48 ]
  • Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 4, 12, 24, and 48 [ Time Frame: week 4,12,24, and 48 ]
  • Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 4, 12, 24, and 48 [ Time Frame: week 4,12,24, and 48 ]
  • Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 4, 12, 24, and 48 [ Time Frame: week 4,12,24, and48 ]
  • Occurrence of HBV Resistance Mutations [ Time Frame: Baseline to Week 48 ]
  • off-treatment recurrence of HBV [ Time Frame: Week 72 to 96 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
Official Title  ICMJE Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Other: UC-MSCs by peripheral intravenous infusion
  • Drug: received hormone maintenance therapy
Study Arms  ICMJE
  • Experimental: UC-MSCs
    UC-MSCs by peripheral intravenous infusion
    Intervention: Other: UC-MSCs by peripheral intravenous infusion
  • Active Comparator: control
    received hormone maintenance therapy
    Intervention: Drug: received hormone maintenance therapy
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2017)		 82
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)		 90
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT02445547
Other Study ID Numbers  ICMJE UCMSC-CD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fuzhou General Hospital
Original Responsible Party dongliangli, Fuzhou General Hospital, Director, Department of Hepatobiliary Disease
Current Study Sponsor  ICMJE Fuzhou General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Shaanxi Provincial People's Hospital
Investigators  ICMJE Not Provided
PRS Account Fuzhou General Hospital
Verification Date January 2017

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