A randomized, double-blinded, placebo controlled, prospective, clinical phase II study to assess the safety and efficacy of expanded allogeneic adipose-derived stem cells (ASCs) for the treatment of complex perianal fistulas in Crohn???s disease. - Allogeneic ASCs in Complex Perianal Crohn's Fistulas

eids Universitair Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•1. Subject must be at least 18 years of age,
•2. Subjects must have had CD for at least three months from the time of initial diagnosis. The diagnosis of CD must have been confirmed endoscopically and/or radiographically,
•3. Subjects must have up to a maximum of three peri-anal fistulas with per fistula up to three visible tracts assessed by MRI unresponsive to conventional treatment (antibiotics, 5ASA, SPS, corticosteroids, thiopurines, methotrexate and infliximab),
•4. At some time during the course of the disease, the subject must have received both steroids, immunosuppressive agents (for example, azothioprine, 6-mercaptopurine, methotrexate) and biological therapy such as infliximab,
•5. Subject is willing to participate in the study and has signed informed consent,
•6. If female and of child-bearing age, subject must be non-pregnant, non-breast-feeding, and use adequate contraception. If male, subject must use adequate contraception.

•1. Dominant active luminal disease requiring immediate therapy,
•2. Abscesses requiring surgery,
•3. Pregnant or breastfeeding women,
•4. Presence of significant clinical bowel obstruction,
•5. Abnormal liver function,
•6. Patient has severe renal insufficiency defined as patients wit a glomerular filtration rate (GFR) below 60 mL/min/1.73 m2 calculated by MDRD (Modification of Diet in Renal Disease),
•7. Enteric pathogens, including C. difficile,
•8. History of colonic mucosal dysplasia,
•9. Subjects with a malignant tumor, except for completely resected basal or squamous cell carcinoma of skin, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years,
•10. Subjects allergic to local anesthetics or gadolinium (MRI contrast),
•11. When MRI is unfeasible (e.g. due to the presence of a pacemaker or in case of claustrophobia),
•12. Changes in concomitant medication:
•- 5-ASA and steroids (prednisone max. 15 mg/d) should be on a stable dose for at least 2 weeks,
•- Tacrolimus or cyclosporine should not be administered in the 4 weeks prior to study,
•- Immunosuppressants (e.g. azathioprine, 6MP or methotrexate) should be on a stable dose for a te least 6 weeks,
•- Infliximab or other anti-TNF antibody therapy should not be administered within 8 weeks prior to enrollment in the study.

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