Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
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ClinicalTrials.gov Identifier: NCT02445547 |
Recruitment Status :
Completed
First Posted : May 15, 2015
Last Update Posted : January 18, 2017
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: UC-MSCs
UC-MSCs by peripheral intravenous infusion
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Other: UC-MSCs by peripheral intravenous infusion |
Active Comparator: control
received hormone maintenance therapy
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Drug: received hormone maintenance therapy |
- Crohn's disease activity index [ Time Frame: 12 months ]
- Harvey-Bradshaw index [ Time Frame: 12 months ]
- Corticosteroid dosage [ Time Frame: 12 months ]

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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 |
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

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
China, Shaanxi | |
Shaanxi Provincial People's Hospital | |
Xi Ail, Shaanxi, China, 111111 |
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 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |