E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
ConditionAnal Fistula
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.
Eligibility criteria
Qualifiers
Subject ages 18 or older
Subject willing and able to provide informed consent
Subject is medically eligible and have agreed to undergo a fistulotomy
Subject with simple perianal fistula with 2 or fewer fistula tracts
Disqualifiers
Concomitant rectovaginal fistulas
Subjects with an abscess
Presence of active infections findings (e.g.; redness, swelling, tenderness or fever)
Presence of rectal and/or anal stenosis
Trial design
Treatments tested in this trial
- E-CEL UVEC
Treatment groups
39 Participants
are divided into 5 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Angiocrine Bioscience
Collaborator
Source ClinicalTrials.gov