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Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

NCT ID: NCT01221428

Last Updated: 2010-10-15

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

Detailed Description

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Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract．Nowadays，etiology and pathogenesis of UC have been unclear．Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract，which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.

Conditions

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Ulcerative Colitis Mesenchymal Stem Cells Umbilical Cord

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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umbilical cord mesenchymal stem cells

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells,one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery.

Group Type EXPERIMENTAL

Umbilical Cord Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(2\*10/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(1\*10/7).

Interventions

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Umbilical Cord Mesenchymal Stem Cells

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(2\*10/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(1\*10/7).

Intervention Type BIOLOGICAL

Other Intervention Names

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Mesenchymal Stem Cells

Eligibility Criteria

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Inclusion Criteria

* Male or female, 18 years of age or older.
* Ulcerative colitis described according to usual criteria.
* Refractoriness Ulcerative colitis or unefficient by using other therapy
* Signed informed consent form.

Exclusion Criteria

* History of neoplasm or hematological disease
* Uncontrolled high blood pressure (\>180/110)
* Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30%
* Malignant ventricular arrythmia
* Deep venous thrombosis during the last 3 months
* Active bacterial infection
* Body mass index \> 35 Kg/m2
* Stroke or myocardial infarction during the last 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Principal Investigators

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Gang Zhao, MD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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MSCKJ004

Identifier Type: -

Identifier Source: org_study_id