Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's… (NCT01541579) | Clinical Trial Compass
CompletedPhase 3
Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease
Austria, Belgium278 participantsStarted 2012-07
Plain-language summary
The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent.
✓. Patients with Crohn's Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria.
✓. Presence of complex perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI. Fistula must have been draining for at least 6 weeks prior to the inclusion. A complex perianal fistula is defined as a fistula that met one or more of the following criteria during its evolution:
✓. Non-active or mildly active luminal CD defined by a CDAI ≤ 220.
✓. Patients of either sex aged 18 years or older
✓. Good general state of health according to clinical history and a physical examination.
✓. For women of a childbearing age, they must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin (hCG)). Both men and women should use appropriate birth control methods defined by the investigator.
Exclusion criteria
✕. Presence of dominant luminal active Crohn's disease requiring immediate therapy.
✕. CDAI \>220.
✕. Concomitant rectovaginal fistulas
✕. Patient naïve to specific treatment for perianal fistulising Crohn's disease including antibiotics