Actively Recruiting
An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of 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
300 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
Researchers are evaluating the safety of endothelial cells derived from human umbilical veins as an additional treatment alongside fistulotomy surgery for patients with simple anal fistulas. These specially engineered cells, called E-CEL UVEC, are designed to improve healing after surgery. The study aims to assess the preliminary safety of these cells and observe their effects on fistula healing, based on promising animal study results. Participants with simple anal fistulas undergoing fistulotomy may receive injections of E-CEL UVEC cells directly into the fistula area during surgery. Different parts of the study involve various treatment approaches, including injection without fistulotomy or multiple injections over several months, with doses carefully controlled. Some participants may receive up to six treatments over a six-month period, with injections targeting both sides of the fistula tract and the internal opening. During the study, participants will be monitored for safety by tracking any treatment-related adverse events within two weeks after administration. Researchers will also evaluate the rate of fistula relapse and healing success over 6 to 24 weeks after surgery. Assessments include fistula leakage and time to complete healing. The study involves regular treatment visits and follow-up assessments, with ongoing safety oversight throughout the trial period.
CONDITIONS
Brief 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 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 or Ulcerative Colitis
- For female subjects of childbearing potential: negative serum or urine pregnancy test at screening
- Female subjects must be willing to use a highly effective method of contraception throughout the study
- Male subjects who can father a child and have intercourse with females of childbearing potential must use contraception and avoid sperm donation for at least 1 year after treatment
You will not qualify if you...
- Presence of concomitant rectovaginal fistulas
- Subjects with an abscess
- Active infections such as redness, swelling, tenderness, or fever
- Presence of rectal and/or anal stenosis
- Presence of setons unless removed prior to treatment
- Ongoing steroid treatment or steroid use within the last 4 weeks
- Renal impairment with creatinine clearance below 90 mL/min or high serum creatinine
- Hepatic impairment with elevated bilirubin or liver enzymes
- History of alcohol or substance abuse in the past 6 months
- Active malignant tumor within 5 years
- Recent history of severe, uncontrolled diseases affecting major organs
- Congenital or acquired immunodeficiencies including HIV/AIDS
- Major surgery or severe trauma within previous 6 months
- Candidates for or likely to need solid organ transplantation
- Females who are pregnant, breastfeeding, or planning pregnancy during treatment
- Known allergy or hypersensitivity to DMSO
- Inability or unwillingness to comply with study procedures
- Receipt of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive injections of E-CEL UVEC cells to aid healing of their anal fistula. Treatment involves injection at the time of fistulotomy or outpatient curettage depending on the cohort. Some cohorts receive multiple treatments over several months.
Up to 6 visits over 6 months depending on cohort
Duration - Up to 24 weeks after surgery or treatment
Participants are monitored for safety and healing progress after treatment, including assessments for fistula relapse and healing.
Follow-up visits as scheduled up to 24 weeks
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
A
Ananya Sen
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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