An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Weill Medical College of Cornell University
Summary
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.
Description
The purpose of this study is to test the safety of E-CEL UVEC® cells and see what effects (good and bad) it has on your anal fistula. It is hoped, that the E-CEL UVEC® cells may help to improve healing of your fistula after surgery. E-CEL UVEC® cells are genetically engineered human endothelial cells that are taken from the umbilical cords of newborn babies. The endothelial cells are cells that line the inside of blood vessels including the umbilical cord. Human umbilical endothelial cells are collected from the umbilical cord of a healthy newborn baby. The cells are obtained under strict Uni…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Maximum tract length of 3 inches * Subject without history of Crohn's disease/ Ulcerative Colitis * For female subjects of childbearing potential: * A negative serum or urine pregnancy test at screening is required prior to enrollment * Subject must be willing to use a highly effective method of contraception from the start of the screening period th…
Interventions
- DrugE-CEL UVEC
Injection of E-CEL UVEC
Location
- Weill Cornell Medical College - NewYork-Presbyterian HospitalNew York, New York