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:
Fuzhou General Hospital
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 |
Crohn's disease activity index [ Time Frame: 12 months ] | ||
Original Primary Outcome Measures ICMJE |
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 4 [ Time Frame: week 4 ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
|
||
Original Secondary Outcome Measures ICMJE |
|
||
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 |
|
||
Study Arms ICMJE |
|
||
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 |
82 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
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 |