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Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UC-MSCs by peripheral intravenous infusion
received hormone maintenance therapy
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaanxi Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UC-MSCs

control

Arm Description

UC-MSCs by peripheral intravenous infusion

received hormone maintenance therapy

Outcomes

Primary Outcome Measures

Crohn's disease activity index

Secondary Outcome Measures

Harvey-Bradshaw index
Corticosteroid dosage

Full Information

First Posted
May 13, 2015
Last Updated
January 16, 2017
Sponsor
Fuzhou General Hospital
Collaborators
Shaanxi Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02445547
Brief Title
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
Official Title
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuzhou General Hospital
Collaborators
Shaanxi Provincial People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs
Arm Type
Experimental
Arm Description
UC-MSCs by peripheral intravenous infusion
Arm Title
control
Arm Type
Active Comparator
Arm Description
received hormone maintenance therapy
Intervention Type
Other
Intervention Name(s)
UC-MSCs by peripheral intravenous infusion
Intervention Type
Drug
Intervention Name(s)
received hormone maintenance therapy
Primary Outcome Measure Information:
Title
Crohn's disease activity index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Harvey-Bradshaw index
Time Frame
12 months
Title
Corticosteroid dosage
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Shaanxi Provincial People's Hospital
City
Xi Ail
State/Province
Shaanxi
ZIP/Postal Code
111111
Country
China

12. IPD Sharing Statement

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Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

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