The Efficiency of MSC in Refractory Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02532738
• Other study ID #: MSCINRCD
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: August 23, 2015
• Last updated: August 25, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Sun Yat-sen University, Guangzhou
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Routine Treatment of CD
The Drug including 6MP, AZA, infliximab and thalidomide

Biological:
• MSC treatment 01
Injection of 3×10E6/kg of MSC
• MSC treatment 02
Injection of 6×10E6/kg of MSC

Other:
• NS
Injection of NS

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Nanfang Hospital of Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No