Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease
The purpose of this phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Signed informed consent 2. Patients of either gender ≥ 18 years and ≤75 years of age 3. Patients with Crohn's Disease (CD) diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria 4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings 5. Clinically controlled, non active or mildly active CD, during the last six months prior to Screening visit. 6. Patients whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or TNF-α antagonist or vedolizumab or ustekinumab, or having documented intolerance 7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both WCBP or male patients participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study.
Exclusion Criteria:1. Concomitant rectovaginal or rectovesical fistula(s) 2. Patient naïve to prior specific medical treatment for perianal complex fistula(s) including IS or anti-TNFs. 3. Presence of a perianal collection > 2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon 4. Severe rectal and/or anal stenosis that make impossible to follow the surgical protocol 5. Patient with diverting stomas 6. Active, uncontrolled infection requiring parenteral antibiotics 7. Patient with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to Screening visit 8. Patients with major alteration on any of the following laboratory tests or increased risk for the surgical procedure: 1. Serum creatinine levels >1.5 upper limit of normality (ULN) 2. Total bilirubin >1.5 ULN 3. AST/ALT >3.0 ULN 4. Hemoglobin <10.0 g/dL 5. Platelets <75.0 x109/L 6. Albuminemia < 3.0 g/dL 9. Suspected or documented infectious enterocolitis within two weeks prior to Screening visit 10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Patients with basal-cell carcinoma of the skin completely resected outside the perineal region can be included 11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in patients increased risk from study participation and/or lack of compliance with study procedures 12. Patients with primary sclerosing cholangitis 13. Patients with known chronically active hepatopathy of any origin, including cirrhosis and patients with persistent positive HBV surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for HCV and quantitative HCV PCR within 6 months prior to Screening. 14. Congenital or acquired immunodeficiencies, including patients known to be HIV carriers 15. Known allergies or hypersensitivity to penicillin or aminoglycosides; DMEM (Dulbecco Modified Eagle's Medium); bovin serum; local anaesthetics or gadolinium (MRI contrast) 16. Contraindication to MRI scan (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia) 17. Major surgery or severe trauma within 6 months prior to Screening visit 18. Pregnant or breastfeeding women 19. Patients who do not wish to or cannot comply with study procedures 20. Patients currently receiving, or having received any investigational drug for CD or the perianal fistula(s) within 3 months prior to Screening visit 21. Patients previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study 22. Surgery of one or more segments of the colon or terminal ileum within 3 months prior to Screening visit 23. Patients who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such major surgery is foreseen in this region in the 24 weeks following treatment administration at the time of screening 24. Contraindication to the anaesthetic procedure
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
The current multicentre phase III study is proposed to evaluate the efficacy and safety of Cx601 compared to placebo for the treatment of complex perianal fistula(s) in patients with Crohn's disease at Week 24 with a follow-up period up to 52 weeks. The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both patient and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy . The study will follow an add-on design, patients receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the Crohn's disease (CD) will be allowed to continue it throughout the study. Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS).
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