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

Exclusion Criteria

• •1. Clinically significant medical conditions within the six months before screening 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.
• •2. Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies.
• •3. 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.
• •4. History (within previous 5 years of screening visit) of invasive cancer including melanoma (with the exception of localized skin cancers).
• •5. Subjects pregnant, trying to become pregnant, or are breast feeding.
• •6. Subjects with known allergies or hypersensitivity to aminoglycosides and contraindications to Magnetic Resonance (MR) evaluations and/or to MR contrast.
• •7. History of clinically significant fat-directed autoimmunity.
• •8. Genito-urinary fistulization, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
• •9. Presence of an ileal anal pouch.
• •10. Active, unresolved infection requiring parenteral antibiotics.
• •11. 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.
• •12. Subjects who had a definitive surgical procedure for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit.
• •13. Subjects where the target adipose collection harvest site is compromised due to a previous cool sculpting procedure, local radiation, chemotherapy, recent tattoos, local infection, or other reasons that may compromise the adipose tissue for study use.
• •14. Subjects previously treated with Cx601/Alofisel or other allogeneic or autologous stem-cell therapy within the past 6 months.
• •15. Contraindications to the anesthetic procedure (local and general) or to the adipose tissue collection procedure.
• •16. Subjects with one or more of the following fistula types or anatomic presentations:
• •1. Horseshoe fistulas
• •2. Fistulas that do not have an opening inside the anal canal or low rectum
• •3. Blind ending sinus tracts (no external opening)
• •4. Branching fistulas. A previously performed conversion of a branching fistula tract to a single tract is not exclusionary
• •5. \>1 internal opening
• •6. Moderate or severe proctitis
• •7. Severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug cap.
• •8. Any anatomical limitation to successfully securing the fistula plug cap
• •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 (creatinine value \> 1.8 mg/dL, eGFR \< 44, or patient undergoing dialysis).
• •21. Subjects with a hemoglobin less than 8 gm/dL.
• •22. Subjects with serum aspartate transaminase (AST) or alanine transaminase (ALT) \> 2 times the upper limit of normal (ULN).
• •23. Subjects with an abscess within the fistula tract that cannot be resolved prior to treatment.
• •24. Subjects with known coagulopathy (abnormal INR) or thrombocytopenia as indicated by a platelet count \< 75,000.
• •25. Subjects with history of substance abuse (drug or alcohol) that would interfere with the ability to comply with the study protocol and study requirements.