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NCT02445547 Clinical Trial

Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

Crohn Disease Clinical Trial

Official title:
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02445547
Other study ID # UCMSC-CD
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 13, 2015
Last updated January 16, 2017
Start date June 2012

Study information
Verified date January 2017
Source Fuzhou General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• UC-MSCs by peripheral intravenous infusion

Drug:
• received hormone maintenance therapy

Locations
Country Name City State
China Shaanxi Provincial People's Hospital Xi Ail Shaanxi

Sponsors (2)
Lead Sponsor Collaborator
Fuzhou General Hospital Shaanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Crohn's disease activity index 12 months
Secondary Harvey-Bradshaw index 12 months
Secondary Corticosteroid dosage 12 months
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