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Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC-1 | Experimental | Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg |
|
| MSC-2 | Experimental | Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg |
|
| Ctrl | Experimental | Patient in this arm will receive routine surgery and local NS injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine drainage surgery | Procedure |
| ||
| MSC injection 01 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response(fistula closure) | Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein (CRP) | To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP) | 12 weeks |
| Clinical Response | CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores." Clinical Response of patients 6 weeks after receiving treatment (CDAI score less than 150) |
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Inclusion Criteria:
Exclusion Criteria:
17) In the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Biological |
Local MSC injection in peri-anal with a dose of 3×10E6/kg |
|
| MSC injection 02 | Biological | Local MSC injection in peri-anal with a dose of 6×10E6/kg |
|
| placebo | Other | NS injection instead of MSC |
|
| 6 weeks after receiving treatment |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |