The Efficiency of MSC in Refractory Crohn's Disease

Sun Yat-sen University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: MSC treatment 02; Biological: MSC treatment 01; Other: NS; Drug: Routine Treatment of CD

Study type: Interventional

Funder types: Other

Identifiers

NCT02532738

MSCINRCD

Details and patient eligibility

About

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.

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups, including a placebo group

MSC-1

Experimental group

Description:

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

Treatment:

Drug: Routine Treatment of CD

Biological: MSC treatment 01

MSC-2

Experimental group

Description:

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

Treatment:

Drug: Routine Treatment of CD

Biological: MSC treatment 02

Ctrl

Placebo Comparator group

Description:

Patients in this arms receive routine treatment with NS injection

Treatment:

Other: NS

Drug: Routine Treatment of CD