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.
- Conditions
- Crohn's Diseasefistels10017969
- Registration Number
- NL-OMON32259
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of adverse and serious adverse events,<br /><br>The reduction in the number of draining fistulas at 12 weeks. Healing being<br /><br>defined as absence of discharge and complete re-epithelization of the external<br /><br>opening of the fistula and absence of collections of >=2 cm directly related to<br /><br>the treated fistulas tracts as measured by MRI.</p><br>
- Secondary Outcome Measures
Name Time Method