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CompletedNCT02445547Updated Jan 18, 2017

Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

A Phase 1/2 interventional study of UC-MSCs by peripheral intravenous infusion and received hormone maintenance therapy in Crohn Disease, sponsored by Fuzhou General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Fuzhou General Hospital · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Crohn Disease

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03

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's enrollment of 82 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Fuzhou General Hospital is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • active tuberculosis
  • malignancy
  • HIV
  • syphilis
  • hepatitis B
  • hepatitis C
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • 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

Interventions

  • OtherUC-MSCs by peripheral intravenous infusion
  • Drugreceived hormone maintenance therapy
06

What researchers measure

Primary outcomes

  1. Crohn's disease activity index

    Time frame: 12 months

Secondary outcomes

  1. Harvey-Bradshaw index

    Time frame: 12 months

  2. Corticosteroid dosage

    Time frame: 12 months

07

Study locations

1 site
  • Shaanxi Provincial People's Hospital
    XI Ail, Shaanxi 111111, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02445547
Lead sponsor
Fuzhou General Hospital
Collaborators
Shaanxi Provincial People's Hospital
Responsible party
Sponsor
First posted
May 15, 2015
Start date
Jun 2012
Primary completion
Jun 2015
Last update
Jan 18, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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