E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

Inclusion Criteria:

* Subject ages 18 or older
* Subject willing and able to provide informed consent
* Subject is medically eligible and have agreed to undergo a fistulotomy
* Subject with simple perianal fistula with 2 or fewer fistula tracts
* Maximum tract length of 3 inches
* Subject without history of Crohn's disease/ Ulcerative Colitis
* For female subjects of childbearing potential:
* A negative serum or urine pregnancy test at screening is required prior to enrollment
* Subject must be willing to use a highly effective method of contraception from the start of the screening period throughout the study period
* For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
* Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of the conditioning therapy for at least 1 year after completion and discussion with a treating physician

Exclusion Criteria:

* Concomitant rectovaginal fistulas
* Subjects with an abscess
* Presence of active infections findings (e.g.; redness, swelling, tenderness or fever)
* Presence of rectal and/or anal stenosis
* The presence of setons unless removed prior to the treatment
* Subjects with ongoing steroid treatment or treated with steroids in the last 4 weeks
* Renal impairment defined by creatinine clearance below 90 mL/min calculated using Cockcroft-Gault formula or by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
* Hepatic impairment defined by both of the following laboratory ranges:
* Total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN
* Known history of abuse of alcohol or other addictive substances in the 6 months prior to enrollment
* Active malignant tumor within 5 years
* Current recent history of abnormal, severe, progressive, uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
* Congenital or acquired immunodeficiencies including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
* Major surgery or severe trauma within the previous 6 months
* Subjects who are candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (ex. progressive heart failure)
* Females who are who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment
* Subjects who have known hypersensitivity or documented allergy to DMSO
* Subjects who do not wish to or cannot comply with study procedures
* Subjects currently receiving, or having received any investigational drug within 3 months prior to E-CEL UVEC cell therapy