The Efficiency of MSC in Refractory Crohn's Disease

Phase 2

• Conditions: Crohn's Disease
• Interventions: Drug: Routine Treatment of CD; Biological: MSC treatment 02; Biological: MSC treatment 01; Other: NS

• Registration Number: NCT02532738
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-25
• Last Update Submitted: 2015-08-25
• Study First Posted: 2015-08-26
• Last Update Posted: 2015-08-26
• Study Start: 2016-01
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC-2	Routine Treatment of CD	Patients in this arms receive routine treatment with 6×10E6/kg of MSC
MSC-2	MSC treatment 02	Patients in this arms receive routine treatment with 6×10E6/kg of MSC
MSC-1	Routine Treatment of CD	Patients in this arms receive routine treatment with 3×10E6/kg of MSC
MSC-1	MSC treatment 01	Patients in this arms receive routine treatment with 3×10E6/kg of MSC
Ctrl	Routine Treatment of CD	Patients in this arms receive routine treatment with NS injection
Ctrl	NS	Patients in this arms receive routine treatment with NS injection

Primary Outcome Measures

Name	Time	Method
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)	12 weeks after receiving treatment	Reduction of CDAI score at less 100

Secondary Outcome Measures

Name	Time	Method
Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)	6 weeks after receiving treatment	CDAI score less than 150