E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 United States (U.S.) Food and Drug Administration (FDA) regulations. The endothelial cells are engineered in the laboratory, meaning an extra gene is added. A gene is taken from a virus (just a single gene, not the entire virus) and inserted into the endothelial cells.This causes the endothelial cells to be more stable and improves their growth capabilities. In animal studies, the endothelial cells were cleared from the body within a month. No negative side effects related to the endothelial cells were seen in animal studies. A higher than normal healing response was seen in animal studies. This research study is being done because, in animal studies, E-CEL UVEC® cells have been shown to speed up healing in various tissues and organs. This study will test if it is safe to use E-CEL UVEC® cells and if they help to improve healing of your fistula after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04190862
Study type	Interventional
Source	Weill Medical College of Cornell University
Contact	Rohit Rasane
Phone	646-962-2789
Email	rkr4004@med.cornell.edu
Status	Recruiting
Phase	Phase 1
Start date	January 22, 2020
Completion date	June 30, 2032

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06092398` - Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula	N/A
Active, not recruiting	`NCT06243302` - Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
Terminated	`NCT02423330` - A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula	Early Phase 1
Completed	`NCT01012843` - Do Antibiotics Prevent Anal Fistulae Formation?	N/A
Recruiting	`NCT04750499` - Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection	N/A
Not yet recruiting	`NCT04541238` - Imaging Template for Reporting Anal Fistula
Recruiting	`NCT05044182` - Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula	N/A
Recruiting	`NCT03690934` - Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).	N/A
Recruiting	`NCT01388257` - Anal Crohn Fistula Surgery	N/A
Active, not recruiting	`NCT00115466` - Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula	Phase 2
Not yet recruiting	`NCT03311035` - LIFT Technique Versus Seton in Management of Anal Fistula	N/A
Recruiting	`NCT04790123` - Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula	N/A
Completed	`NCT05605080` - Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery	N/A
Recruiting	`NCT04119700` - Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas	N/A
Recruiting	`NCT01997645` - Surgical Treatment of High Perianal Fistulas	N/A
Terminated	`NCT01584752` - Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas
Completed	`NCT04811105` - INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS	N/A
Not yet recruiting	`NCT05476146` - Re-routing in Treatment High Anal Fistula	N/A
Recruiting	`NCT04616911` - Rerouting Seton Versus LIFT for Complex Anal Fistula	N/A
Completed	`NCT03345511` - Ultrasound Guided Caudal Block for Benign Anal Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.