Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

• Sponsor: Fuzhou General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02445547
• Collaborator: Shaanxi Provincial People's Hospital (Other)
• Enrollment: 82
• Location: 1
• Arms: 2

Study Details

Study Description

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.

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 Design

• Study Type: Interventional
• 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: Jun 1, 2012
• Actual Primary Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UC-MSCs UC-MSCs by peripheral intravenous infusion	Other: UC-MSCs by peripheral intravenous infusion
Active Comparator: control received hormone maintenance therapy	Drug: received hormone maintenance therapy

Outcome Measures

Primary Outcome Measures

1. Crohn's disease activity index [12 months]

Secondary Outcome Measures

1. Harvey-Bradshaw index [12 months]

2. Corticosteroid dosage [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaanxi Provincial People's Hospital	Xi Ail	Shaanxi	China	111111

Sponsors and Collaborators

• Fuzhou General Hospital
• Shaanxi Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fuzhou General Hospital
• ClinicalTrials.gov Identifier: NCT02445547
• Other Study ID Numbers: UCMSC-CD
• First Posted: May 15, 2015
• Last Update Posted: Jan 18, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Crohn Disease; Hormones

Study Results

No Results Posted as of Jan 18, 2017