A 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(

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Perianal Fistula
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects must be over the age of 18 years old
    2. Subjects provide signed informed consent
    3. Subjects 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. Subjects with presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment
    5. Subjects with clinically controlled, non active or mildly active CD
    6. Subjects whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response
    7. Female subjects of childbearing potential (WCBP) must have negative serum pregnancy test at Screening

You may not be eligible for this study if the following are true:

    1. Subjects with concomitant rectovaginal or rectovesical fistula(s)
    2. Subjects who are naïve to prior specific medical treatment for complex perianal fistula(s) including IS or anti-TNFs
    3. Subjects with Presence of a perianal collection >2 cm in at least two dimensions on the central reading MRI
    4. Subjects with severe rectal and/or anal stenosis and/or severe proctitis
    5. Subjects with diverting stomas
    6. Subjects with active, uncontrolled infection requiring parenteral antibiotics
    7. Subjects with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit
    8. Subjects with major alteration on any laboratory tests as per the protocol
    9. Subjects with suspected or documented infectious enterocolitis within 2 weeks prior to Screening visit
    10. Subjects with any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit
    11. Subjects with current or recent 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. Subjects with primary sclerosing cholangitis
    13. Subjects 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 visit.
    14. Subjects with congenital or acquired immunodeficiencies, including patients known to be HIV carriers
    15. Subjects with known allergies or hypersensivity to penicillin or aminoglycosides
    16. Subjects with contraindication to MRI scan
    17. Subjects who have had severe trauma within 6 months prior to Screening visit
    18. Pregnant or breastfeeding women
    19. Subjects who do not wish to or cannot comply with study procedures
    20. Subjects who are currently receiving, or having received any investigational drug within 3 months prior to Screening visit
    21. Subjects previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study
    22. Subjects with any major surgery of the GI tract
    23. Subjects who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit
    24. Subjects with contraindication to the anaesthetic procedure

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.