The Efficiency of MSC in Refractory Crohn's Disease

Study Overview
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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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Routine Treatment of CD
* Biological: MSC treatment 01
* Biological: MSC treatment 02
* Other: NS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 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) | CDAI score less than 150 | 6 weeks after receiving treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy of MSC, refractory