Actively Recruiting
E-CEL UVEC Treatment for Anal Fissures
Led by Weill Medical College of Cornell University · Updated on 2026-04-08
20
Participants Needed
1
Research Sites
115 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
This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure. The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure.
CONDITIONS
Official Title
E-CEL UVEC Treatment for Anal Fissures
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Adults 18 years and older
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Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
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Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
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Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
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Vital signs upon screening:
- Blood pressure: systolic ≥ 90 and < 140; and diastolic ≥ 60 and < 90.
- Breathing: ≥ 12 and ≤ 20 breaths per minute.
- Pulse: ≥ 60 and ≤ 100 beats per minute.
- Temperature: ≥ 97.8°F and ≤ 99.1°F (36.5°C to 37.3°C)
- O2 saturation: > 92%
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Willing to take adequate contraceptive measures
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Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires
You will not qualify if you...
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Lateral anal fissure
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Presence of peri-anal or rectovaginal fistula, rectal or anal stenosis, or peri-anal abscess or non-healing peri-anal post-surgical wounds that are not anal fissures (subjects with history of anorectal surgery with healed surgical wound is not excluded)
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Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
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Active systemic infection (e.g., bacteremia, sepsis) - stable, controlled and treated HIV+ subjects (e.g., recent plasma HIV RNA <200 copies/mL) are not excluded
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Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
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Taking systemic chemotherapy or local pelvic radiation treatments
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Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
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Hepatic impairment defined by both of the following laboratory ranges:
(a) total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia; and (b) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN
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Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up.
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Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation)
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Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
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Congenital immunodeficiencies
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History of major surgery or severe trauma within the previous 3 months
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Subjects who are actively being considered as candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (ex. Progressive heart failure)
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Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days)
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Subjects who have known hypersensitivity or documented allergy to DMSO
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Subjects who do not wish to or cannot comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
K
Kelly Garrett, MD
CONTACT
K
KM Muktasid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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