Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
Phase 1
Completed
- Conditions
- Crohn Disease
- Interventions
- Other: UC-MSCs by peripheral intravenous infusionDrug: received hormone maintenance therapy
- Registration Number
- NCT02445547
- Lead Sponsor
- Fuzhou General Hospital
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UC-MSCs UC-MSCs by peripheral intravenous infusion UC-MSCs by peripheral intravenous infusion control received hormone maintenance therapy received hormone maintenance therapy
- Primary Outcome Measures
Name Time Method Crohn's disease activity index 12 months
- Secondary Outcome Measures
Name Time Method Harvey-Bradshaw index 12 months Corticosteroid dosage 12 months
Trial Locations
- Locations (1)
Shaanxi Provincial People's Hospital
🇨🇳Xi Ail, Shaanxi, China