The Efficiency of MSC in Refractory Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Routine Treatment of CD
MSC treatment 01
MSC treatment 02
NS
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring efficacy of MSC, refractory
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MSC-1
MSC-2
Ctrl
Arm Description
Patients in this arms receive routine treatment with 3×10E6/kg of MSC
Patients in this arms receive routine treatment with 6×10E6/kg of MSC
Patients in this arms receive routine treatment with NS injection
Outcomes
Primary Outcome Measures
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
Reduction of CDAI score at less 100
Secondary Outcome Measures
Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)
CDAI score less than 150
Full Information
NCT ID
NCT02532738
First Posted
August 23, 2015
Last Updated
August 25, 2015
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02532738
Brief Title
The Efficiency of MSC in Refractory Crohn's Disease
Official Title
A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
efficacy of MSC, refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSC-1
Arm Type
Experimental
Arm Description
Patients in this arms receive routine treatment with 3×10E6/kg of MSC
Arm Title
MSC-2
Arm Type
Experimental
Arm Description
Patients in this arms receive routine treatment with 6×10E6/kg of MSC
Arm Title
Ctrl
Arm Type
Placebo Comparator
Arm Description
Patients in this arms receive routine treatment with NS injection
Intervention Type
Drug
Intervention Name(s)
Routine Treatment of CD
Intervention Description
The Drug including 6MP, AZA, infliximab and thalidomide
Intervention Type
Biological
Intervention Name(s)
MSC treatment 01
Intervention Description
Injection of 3×10E6/kg of MSC
Intervention Type
Biological
Intervention Name(s)
MSC treatment 02
Intervention Description
Injection of 6×10E6/kg of MSC
Intervention Type
Other
Intervention Name(s)
NS
Other Intervention Name(s)
normal saline
Intervention Description
Injection of NS
Primary Outcome Measure Information:
Title
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
Description
Reduction of CDAI score at less 100
Time Frame
12 weeks after receiving treatment
Secondary Outcome Measure Information:
Title
Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)
Description
CDAI score less than 150
Time Frame
6 weeks after receiving treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
The Efficiency of MSC in Refractory Crohn's Disease
We'll reach out to this number within 24 hrs