The Efficiency of MSC in Refractory Crohn's Disease

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

PHASE2/PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's 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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MSC-1

Patients in this arms receive routine treatment with 3×10E6/kg of MSC

Group Type EXPERIMENTAL

Routine Treatment of CD

Intervention Type DRUG

The Drug including 6MP, AZA, infliximab and thalidomide

MSC treatment 01

Intervention Type BIOLOGICAL

Injection of 3×10E6/kg of MSC

MSC-2

Patients in this arms receive routine treatment with 6×10E6/kg of MSC

Group Type EXPERIMENTAL

Routine Treatment of CD

Intervention Type DRUG

The Drug including 6MP, AZA, infliximab and thalidomide

MSC treatment 02

Intervention Type BIOLOGICAL

Injection of 6×10E6/kg of MSC

Ctrl

Patients in this arms receive routine treatment with NS injection

Group Type PLACEBO_COMPARATOR

Routine Treatment of CD

Intervention Type DRUG

The Drug including 6MP, AZA, infliximab and thalidomide

NS

Intervention Type OTHER

Injection of NS

Interventions

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Routine Treatment of CD

The Drug including 6MP, AZA, infliximab and thalidomide

Intervention Type DRUG

MSC treatment 01

Injection of 3×10E6/kg of MSC

Intervention Type BIOLOGICAL

MSC treatment 02

Injection of 6×10E6/kg of MSC

Intervention Type BIOLOGICAL

NS

Injection of NS

Intervention Type OTHER

Other Intervention Names

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normal saline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No