Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

NCT ID: NCT02445547

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UC-MSCs

UC-MSCs by peripheral intravenous infusion

Group Type EXPERIMENTAL

UC-MSCs by peripheral intravenous infusion

Intervention Type OTHER

control

received hormone maintenance therapy

Group Type ACTIVE_COMPARATOR

received hormone maintenance therapy

Intervention Type DRUG

Interventions

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UC-MSCs by peripheral intravenous infusion

Intervention Type OTHER

received hormone maintenance therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shaanxi Provincial People's Hospital

XI Ail, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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UCMSC-CD

Identifier Type: -

Identifier Source: org_study_id

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