Gender
All
Age Group
18 Years to 70 Years
Accepting Healthy Volunteers
No
Inclusion 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. Subjects with CD diagnosed at least 6 months prior to screening visit.
5. Subjects with a single fistula tract with one internal opening and one external
opening.
6. Subjects whose perianal fistula(s) were previously treated with either biologic or
conventional therapy 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 (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:
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.
