Health TrialsbyHealthPanel

E-CEL UVEC Treatment for Anal Fissures

ConditionChronic Anal Fissure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • E-CEL UVEC cells (AB-207)

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of severe injection site reactions

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

Time frame
Up to 180 days
2

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

Time frame
Up to 180 days
3

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

Time frame
Up to 180 days

Secondary outcomes

1

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.

Time frame
Days 0, 14, 21, 28, 42, 56, 90 and 180
2

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 (Day 0)

Time frame
Days 14, 21, 28, 42, 56, 90 and 180
3

Change in proportion of subjects

Subjects with ≥ 50% reduction in pain-on-defecation (NRS) from baseline (Day 0)

Time frame
Days 0, 14, 21, 28, 42, 56, 90 and 180
4

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

Time frame
Up to 180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Angiocrine Bioscience

Collaborator

Source ClinicalTrials.gov
Apply now