Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP II)

Are you eligible to participate in this study?

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

  • Conditions:
    Crohn's Disease
  • Age: Between 18 Year(s) - 70 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
      In order to be eligible to participate in this study, an individual must meet all of the following criteria:
    1. Provision of signed and dated ICF.
    2. Ability and willingness to comply with study protocol and study requirements for the duration of the study.
    3. Male or female, 18-70 years of age.
    4. Individuals with CD diagnosed at least 6 months prior to screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.
    5. Individuals with a single fistula tract with one internal opening and one external opening, including a previously performed conversion of a branching fistula tract to a single fistula tract where the branching occurred outside the sphincter complex.
    6. Individuals whose perianal fistula(s) were previously treated with either biologic or conventional therapy, such as an immunosuppressive agent (azathioprine, 6- mercaptopurine, and methotrexate) for a minimum duration of 3 months; or anti-tumor necrosis factor (TNF) agent, or vedolizumab, or ustekinumab for a minimum duration of 14 weeks and whose fistula has demonstrated a failed response or who have documented medication intolerance.
    7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening. WCBP participating in this study must agree to use an adequate method of contraception during the entire duration of the study. Males who have sexual partners that are women of childbearing potential must be willing to use a barrier method for contraception for the duration of study.

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

    1. An individual who meets one or more of the following criteria will be excluded from participation in this study:
    2. Clinically significant medical conditions within the six months before screening: e.g., severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that would, in the opinion of the investigator, compromise the safety of the subject with study participation and/or the ability of the subject to follow study protocol.
    3. Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies.
    4. Participation in an investigational drug study (within 30 days of last administration from screening visit) or investigational medical device study (within 1 year of implant from screening visit) where investigational treatment (drug or device) is placed in rectum, vagina, or near fistula location, or that may potentially interact with study treatment.
    5. History (within previous 5 years of screening visit) of invasive cancer including melanoma (with the exception of localized skin cancers).
    6. Subjects who are pregnant, trying to become pregnant, or are breast feeding.
    7. Subjects with contraindications to Magnetic Resonance (MR) evaluations and/or to MR contrast: e.g. pacemaker or magnetically active metal fragments, allergy/sensitivity to gadolinium.
    8. History of clinically significant fat-directed autoimmunity.
    9. Genito-urinary fistulization, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
    10. Presence of an ileal anal pouch.
    11. Active, unresolved infection requiring parenteral antibiotics.
    12. Any major surgery of the gastrointestinal tract (including one or more segments of the colon or terminal ileum) within 3 months prior to screening visit. Presence of stoma is not exclusionary.
    13. Subjects who had a definitive surgical procedure (i.e., Ligation of Intersphincteric Fistula Tract or Endorectal Advancement Flap) for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit.
    14. A compromised abdominal region due to a previous cool sculpting procedure, abdominal radiation, chemotherapy, recent tattoos (within 3 months prior to Week -8 visit), local infection, or other reasons that may compromise the adipose tissue for study use.
    15. Subjects previously treated with Cx601/Alofisel or other allogeneic or autologous stemcell therapy within the past 6 months.
    16. Contraindications to the anesthetic procedure (local and general) or to the adipose tissue collection procedure.
    17. Evidence by colonoscopy of moderately or greater active luminal CD.
    18. Subject with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to screening and baseline study visits.
    19. History of, or concurrent high-grade dysplasia, adenocarcinoma, and carcinoma in situ on colonoscopy within 5 years of screening visit.
    20. Subjects with renal insufficiency.
    21. Subjects with undrained peri-anal sepsis.
    22. Subjects with history of substance abuse (drug or alcohol) that would interfere with the ability to comply with the study protocol and study requirements.

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