NCT02445547

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

May 13, 2015

Last Update Submit

January 16, 2017

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Crohn's disease activity index

    12 months

Secondary Outcomes (2)

  • Harvey-Bradshaw index

    12 months

  • Corticosteroid dosage

    12 months

Study Arms (2)

UC-MSCs

EXPERIMENTAL

UC-MSCs by peripheral intravenous infusion

Other: UC-MSCs by peripheral intravenous infusion

control

ACTIVE COMPARATOR

received hormone maintenance therapy

Drug: received hormone maintenance therapy

Interventions

UC-MSCs by peripheral intravenous infusionOTHER
UC-MSCs
received hormone maintenance therapyDRUG
control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Provincial People's Hospital

XI Ail, Shaanxi, 111111, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 15, 2015

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

CN(1)