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