E-CEL UVEC Treatment for Anal Fissures
NCT Number: NCT06456073
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Chronic Anal Fissure
Interventions: BIOLOGICAL: E-CEL UVEC cells (AB-207)
Sponsor: Weill Medical College of Cornell University
Collaborators: Angiocrine Bioscience
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06-30
Locations: Weill Cornell Medicine, New York, New York, 10065, United States

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.

Primary Outcome Measures: 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 is defined as ≥ 50% reduction in pain-on-defecation (using numerical rating scale (NRS)) and ≥ 50% reduction in fissure-wound area (based on clinical examination supplemented by photo-documentation) from baseline, Up to 180 days
Secondary Outcome Measures: Changes in severity of pain on defecation (NRS) from (Day 0) baseline, Based on Numerical Rating Scale (NRS) measures at timepoints compared to baseline. Scale ranges from 0-10 with 0 representing no pain and severity of pain increasing chronologically., Days 0, 14, 21, 28, 42, 56, 90 and 180|Change in proportion of treated responders, Treated responders are defined as ≥ 50% reduction in pain-on defecation (using numerical rating scale (NRS)) and ≥ 50% reduction in fissure-wound-area (mm2) from baseline (Day 0), 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), Median percent change in fissure wound size based on mm\^2 using digital photo-image analysis, Days 0, 14, 21, 28, 42, 56, 90 and 180|Mean percent change in fissure-wound from baseline (Day 0), Mean percent change in fissure wound size based on mm\^2 using digital photo-image analysis, Days 0, 14, 21, 28, 42, 56, 90 and 180|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 14|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 21|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 28|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 42|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 56|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 90|Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0), Day 180|Time-to-response in days in treated responders, Treated responders are defined as those with ≥50% reduction in pain on defecation (using numerical rating scale (NRS)) and ≥50% reduction in fissure-wound area from baseline (Day 0)., Up to 180 days|Time-to symptom improvement in days in treated subjects who achieved symptom improvement, Symptom improvement is defined as a minimum 50% reduction in pain-on defecation (using numerical rating scale (NRS)) in treated subjects., Up to 180 days|Time-to 50% wound closure in days in subjects who achieved at least 50% wound closure, Up to 180 days|Time-to complete wound closure in days in subjects who achieved complete wound closure, Up to 80|Cumulative number of severe adverse events, defined and graded by NCI CTCAE v5.0, Up to 180 days|Percent of serious adverse events, including relatedness category, Percent of SAE and relatedness categories of SAE as defined and graded by NCI CTCAE v5.0, Up to 180 days|Percent of treatment-emergent adverse events per system organ class (SOC), Up to 180 days|Proportion of fissure relapse in treated subjects, Fissure relapse is defined as worsening of pain and increase in size after healing., Up to 180 days|Time-to-relapse in days in subjects who experienced relapse, Days to relapse from time of healing., Up to 180 days