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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Dec 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for anal fistulas, which are small tunnels that form between the end of the bowel and the skin around the anus. The researchers want to see if using special cells called endothelial cells, taken from human umbilical veins, is safe and can help heal these fistulas when combined with a surgical procedure called fistulotomy. This trial is currently recruiting participants who are 18 years or older and have a simple anal fistula with two or fewer tracts. Participants must be able to provide consent and be medically eligible for surgery.

If you join the study, you will receive the standard surgery along with the new cell therapy. The team will monitor your health and recovery to ensure everything is going well. It's important to note that some people may not qualify for the study, especially those with certain medical conditions or who are taking specific medications. If you're interested in participating, you will need to discuss your eligibility with the research team. This trial is an early phase study, so the main focus is on safety, and participants will be helping to gather important information for future treatments.

Gender

ALL

Eligibility criteria

• 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