Clinical Trials

Inclusion Criteria:

• Provision of signed and dated ICF.
• Ability and willingness to comply with study protocol and study requirements for the duration of the study.
• Male or female, 18-70 years of age.
• Subjects with CD diagnosed at least 6 months prior to screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.
• Subjects 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 (e.g., blind ending tracts and/or other tracts leading to more than one external opening that can be converted into a single tract with one internal and one external opening).
• Subjects 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.
• Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin). 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.

Exclusion Criteria:

• 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.
• Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies.
• 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.
• History (within previous 5 years of screening visit) of invasive cancer including melanoma (with the exception of localized skin cancers).
• Subjects pregnant, trying to become pregnant, or are breast feeding.
• 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.
• History of clinically significant fat-directed autoimmunity.
• Genito-urinary fistulization, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
• Presence of an ileal anal pouch.
• Active, unresolved infection requiring parenteral antibiotics.
• 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.
• 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.
• 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.
• Subjects previously treated with Cx601/Alofisel or other allogeneic or autologous stemcell therapy within the past 6 months.
• Contraindications to the anesthetic procedure (local and general) or to the adipose tissue collection procedure.
• Subjects with one or more of the following fistula types or anatomic presentations:
  • Horseshoe fistulas;
  • Fistulas that do not have an opening inside the anal canal or low rectum;
  • Blind ending sinus tracts (no external opening);
  • Branching fistulas that involve or are near the sphincter complex and cannot be converted to single tracts without risk to injury to the sphincter complex;
  • > 1 internal opening;
  • Moderate or severe proctitis;
  • Severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug disk;
  • Any anatomical limitation to successfully securing the fistula plug disk.
• Evidence by colonoscopy of moderately or greater active luminal CD as defined by an affected surface of greater than 50% in any intestinal segment, or any ulcer greater than 0.5 cm in any segment in the last 12 months.
• Subject with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to screening and baseline study visits.
• History of, or concurrent high-grade dysplasia, adenocarcinoma, and carcinoma in situ on colonoscopy within 5 years of screening visit.
• Subjects with renal insufficiency (serum creatinine value > 1.8 mg/dL, eGFR < 44, or patient undergoing dialysis).
  • eGFR is calculated using the 2009 chronic kidney disease (CKD) epidemiology collaboration (CKD-EPI) equation: eGFR (CKD-EPI) = 141 x min(Scr/k, 1)alpha x max(Scr/k, 1)-1.209 x 0.99 age x 1.018 (if patient is female) x 1.159 (if patient is black);
  • For the formula: age is in years, Scr is serum creatinine, k is 0.7 for females and 0.9 for males, alpha is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, max indicated the maximum of Scr/k or 1.
• Subjects with a hemoglobin less than 8 gm/dL.
• Subjects with serum aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal (ULN).
• Subjects with undrained peri-anal sepsis.
• Subjects with known coagulopathy (abnormal INR) or thrombocytopenia as indicated by a platelet count < 75,000.
• Subjects with history of substance abuse (drug or alcohol) that would interfere with the ability to comply with the study protocol and study requirements.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.