E-CEL UVEC Treatment for Anal Fissures

NCT06456073 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 23-11026760
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Anal Fissure

Keywords

Chronic Anal Fissure

Outcome Measures

Primary Outcomes (3)

• Number of severe injection site reactions

  Severe refers to Grade ≥ 3 as per CTCAE v5.0 terms and grading

  Up to 180 days

• Number of severe injection site reactions that are serious adverse events related to IP

  Up to 180 days

• Proportion of treated responders

  Treated responders defined as absence of the anal fissure with digital (e.g., index finger) palpation by investigator (supplemented by photo-documentation whenever possible) from baseline

  Up to 180 days

Secondary Outcomes (22)

• Changes in severity of pain on defecation (NRS) from (Day 0) baseline

  Days 0, 14, 21, 28, 42, 56, 90 and 180

• Proportion of treated responders

  Days 14, 21, 28, 42, 56, 90 and 180

• Change in proportion of subjects

  Days 0, 14, 21, 28, 42, 56, 90 and 180

• Proportion of treated subjects who have complete cessation of fissure-related symptoms

  Up to 180 days

• Median percent change in fissure-wound from baseline (Day 0)

  Days 0, 14, 21, 28, 42, 56, 90 and 180

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Local percutaneous injection of E-CEL UVEC cells around the anal fissure

Biological: E-CEL UVEC cells (AB-207)

Interventions

E-CEL UVEC cells (AB-207) BIOLOGICAL

Allogeneic (consented-maternal donor) E4ORF1+ (pro-survival gene transduced) human umbilical vein endothelial cells (percutaneous injection formulation)

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years and older
• Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
• Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
• Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
• 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%
• Willing to take adequate contraceptive measures
• Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires

You may not qualify if:

• Lateral anal fissure
• 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)
• Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
• 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
• Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
• Taking systemic chemotherapy or local pelvic radiation treatments
• Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
• 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
• Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up.
• Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation)
• Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
• Congenital immunodeficiencies
• History of major surgery or severe trauma within the previous 3 months
• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Angiocrine Bioscience: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Study Officials

• Kelly Garrett, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Garrett, MD

CONTACT

646-962-2270; keg9034@med.cornell.edu

KM Muktasid

CONTACT

646-962-2789; kmm4010@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)