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

Eligibility 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
• * 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