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

NCT04190862 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Anal Fistula

Interventions

DRUG

E-CEL UVEC

Injection of E-CEL UVEC

Sponsors & Collaborators

  • Angiocrine Bioscience

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jeffrey W Milsom, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2026-09-30
Completion
2032-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190862 on ClinicalTrials.gov