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| Name | Class |
|---|---|
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC-1 | Experimental | Patients in this arms receive routine treatment with 3×10E6/kg of MSC |
|
| MSC-2 | Experimental | Patients in this arms receive routine treatment with 6×10E6/kg of MSC |
|
| Ctrl | Placebo Comparator | Patients in this arms receive routine treatment with NS injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Treatment of CD | Drug | The Drug including 6MP, AZA, infliximab and thalidomide |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| MSC treatment 01 | Biological | Injection of 3×10E6/kg of MSC |
|
| MSC treatment 02 | Biological | Injection of 6×10E6/kg of MSC |
|
| NS | Other | Injection of NS |
|
|
| D007410 | Intestinal Diseases |