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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Local MSC injection in peri-anal with a dose of 3×10E6/kg
Local MSC injection in peri-anal with a dose of 6×10E6/kg
Clinical response(fistula closure)
Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm
Time frame: 12 weeks
C-reactive protein (CRP)
To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)
Time frame: 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)
Time frame: 6 weeks after receiving treatment
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NS injection instead of MSC