Actively Recruiting
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Led by Weill Medical College of Cornell University · Updated on 2025-11-18
39
Participants Needed
1
Research Sites
649 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
A
Angiocrine Bioscience
Collaborating Sponsor
AI-Summary
What this Trial 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. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.
CONDITIONS
Official Title
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject ages 18 or older
- Subject willing and able to provide informed consent
- Subject is medically eligible and has 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 or Ulcerative Colitis
- For female subjects of childbearing potential: negative pregnancy test at screening
- Female subjects must be willing to use highly effective contraception from screening through the study
- Males who can father children and have partners not using adequate contraception must be willing to use contraception and refrain from sperm donation for at least 1 year after treatment completion
You will not qualify if you...
- Presence of concomitant rectovaginal fistulas
- Subjects with an abscess
- Presence of active infection signs such as redness, swelling, tenderness, or fever
- Presence of rectal and/or anal stenosis
- Presence of setons unless removed before treatment
- Ongoing steroid treatment or steroid treatment within the last 4 weeks
- Renal impairment defined by creatinine clearance below 90 mL/min or serum creatinine ≥ 1.5 times the upper limit of normal
- Hepatic impairment defined by total bilirubin ≥ 1.5 times upper limit of normal (except benign congenital hyperbilirubinemia) and AST and ALT ≥ 2.5 times upper limit of normal
- Known history of alcohol or substance abuse within 6 months prior to enrollment
- Active malignant tumor within 5 years
- Current severe, uncontrolled, or progressive serious diseases affecting hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral systems
- Congenital or acquired immunodeficiencies including HIV/AIDS
- Major surgery or severe trauma within previous 6 months
- Candidates for solid organ transplantation or high likelihood of needing one
- Females who are pregnant, breastfeeding, or planning pregnancy during treatment
- Known hypersensitivity or allergy to DMSO
- Subjects unwilling or unable to comply with study procedures
- Subjects currently receiving or having received any investigational drug within 3 months prior to E-CEL UVEC therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
Research Team
K
KM Muktasid
CONTACT
A
Ananya Sen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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