NCT04190862 · Weill Medical College of Cornell University
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
What this study is about
The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels.
View original scientific description
The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 18, 2025 · Source of record for eligibility and locations