Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02445547
• Date of registration: 13/05/2015
• Prospective Registration: No
• Primary sponsor: Fuzhou General Hospital
• Public title: Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
• Scientific title: Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial
• Date of first enrolment: June 2012
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02445547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Other: UC-MSCs by peripheral intravenous infusion

Drug: received hormone maintenance therapy

Primary Outcome(s)

Crohn's disease activity index [Time Frame: 12 months]

Secondary Outcome(s)

Harvey-Bradshaw index [Time Frame: 12 months]

Corticosteroid dosage [Time Frame: 12 months]

Secondary ID(s)

UCMSC-CD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shaanxi Provincial People's Hospital