Actively Recruiting
An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC Cell Therapy for the Treatment of Chronic Anal Fissure
Led by Weill Medical College of Cornell University · Updated on 2026-04-08
20
Participants Needed
1
Research Sites
N/A
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 a new treatment involving E-CEL UVEC cells for adults with chronic anal fissure who have not responded to standard medical therapies. This Phase 1b trial aims to test the initial safety and potential healing effects of these genetically-engineered human umbilical vein endothelial cells injected directly around the fissure. The study is led by colorectal surgeons and seeks to observe changes in fissure healing and pain over time. Participants will receive local injections of the E-CEL UVEC cell product near the anal fissure in a series spaced 3 to 4 weeks apart. All participants receive this experimental treatment, as this is an open-label, single-arm study without a placebo group. The initial treatment and observation period lasts 6 months, followed by annual electronic questionnaires for long-term follow-up. During the study, participants will have their fissures assessed by doctors using physical examination methods accepted by the FDA. Researchers will monitor injection site reactions, pain severity during bowel movements, and wound healing progress at multiple time points up to 180 days. Safety and adverse events will be closely tracked, and participants will be asked to complete questionnaires throughout the study and during long-term follow-up.
CONDITIONS
Brief Title
E-CEL UVEC Treatment for Anal Fissures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Having a chronic anterior or posterior anal fissure lasting 6 weeks or more
- Inadequate response to medical treatment including at least 1 month of vasodilator therapy and declined or failed botulinum injection
- Recent history of pain on defecation rated 4 or higher on the numerical rating scale
- Stable vital signs within specified ranges for blood pressure, breathing, pulse, temperature, and oxygen saturation
- Willingness to use adequate contraception
- Willing to sign informed consent and follow study instructions including visits and questionnaires
You will not qualify if you...
- Presence of lateral anal fissure
- Having peri-anal or rectovaginal fistula, anal or rectal stenosis, peri-anal abscess, or non-healing peri-anal post-surgical wounds unrelated to anal fissure
- Active, untreated, or medically unresponsive infection of anal fissure or fistula
- Active systemic infections like bacteremia or sepsis (stable treated HIV+ patients allowed)
- Diagnosed inflammatory bowel diseases such as Crohn's or ulcerative colitis
- Receiving systemic chemotherapy or local pelvic radiation
- Renal impairment with elevated serum creatinine
- Hepatic impairment defined by specific abnormal lab values unless benign
- Active alcohol or substance use interfering with follow-up
- Active malignant tumors not in remission for at least 6 months
- Recent severe or uncontrolled major organ diseases
- Congenital immunodeficiencies
- Major surgery or severe trauma within past 3 months
- Being considered for or likely needing solid organ transplant
- Pregnant, breastfeeding, or planning pregnancy during study
- Known allergy to DMSO
- Unable or unwilling to comply with study procedures
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 local percutaneous injections of E-CEL UVEC cells around the anal fissure with treatments spaced 3 to 4 weeks apart. Initial safety and efficacy are observed over a 6-month period.
Multiple visits spaced 3 to 4 weeks apart over 6 months
Duration - Annual follow-up after initial 6 months
Participants complete annual electronic questionnaires to monitor long-term outcomes after treatment.
Annual electronic questionnaire
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
K
KM Muktasid
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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