The Efficiency of MSC in Refractory Crohn's Disease

August 25, 2015 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease

The investigators' preliminary study indicates that MSC is effective therapy in treating IBD. But the standard treatment is still lacking and the effect is not stable in IBD patients. This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Failure or intolerance to GC, immune inhibitors and biological agents treatment
  • CDAI between 250-450
  • Weight between 40-150 kg
  • Normal renal function
  • endoscopic or imaging diagnosis of CD in the small intestine, colon ileocolon
  • Signed informed consent

Exclusion Criteria:

  • HIV or active hepatitis patients;
  • Allergic to CT contrast agents, cattle or pig products;
  • Stricture or perforation type CD;
  • Recieved permanent colostomy;
  • Used biological preparation in 3 months
  • Used prednisone > 20 mg/day within 1 month ;
  • Patients with short bowel syndrome;
  • Need total parenteral nutrition;
  • Liver meritorious service is abnormal;
  • Suffering from malignant tumor during the last 5 years;
  • Combined bacterial or viral enteritis;
  • Suffering from intestinal typicality thickening of the living
  • Patients with tuberculosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSC-1
Patients in this arms receive routine treatment with 3×10E6/kg of MSC
Drug: Routine Treatment of CD
The Drug including 6MP, AZA, infliximab and thalidomide
Biological: MSC treatment 01
Injection of 3×10E6/kg of MSC
Experimental: MSC-2
Patients in this arms receive routine treatment with 6×10E6/kg of MSC
Drug: Routine Treatment of CD
The Drug including 6MP, AZA, infliximab and thalidomide
Biological: MSC treatment 02
Injection of 6×10E6/kg of MSC
Placebo Comparator: Ctrl
Patients in this arms receive routine treatment with NS injection
Drug: Routine Treatment of CD
The Drug including 6MP, AZA, infliximab and thalidomide
Other: NS
Injection of NS
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
Time Frame: 12 weeks after receiving treatment
Reduction of CDAI score at less 100
12 weeks after receiving treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)
Time Frame: 6 weeks after receiving treatment
CDAI score less than 150
6 weeks after receiving treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborators

Nanfang Hospital of Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 23, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCINRCD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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