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NCT04190862 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Anal Fistula, sponsored by Weill Medical College of Cornell University.

Recruiting
Registry status
Phase 1
Development phase
39
Enrollment target
1
Study location

NCT04190862: Recruiting Phase 1 study of Anal Fistula, sponsored by Weill Medical College of Cornell University.

NCT04190862 is a Phase 1 study of Anal Fistula that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 39 participants, below the 294-participant average among 5 other Anal Fistula trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04190862, a Phase 1 study of Anal Fistula, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.

RECRUITING
Registry status
Phase 1
Development phase
39 participants
Enrollment target
1
Study location

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.

Primary Outcome

The short term safety of escalating dose of E-CEL UVEC cells in subjects with anal fistulas will be assessed by monitoring and recording all adverse events for 2 weeks following the administration of E-CEL UVEC. (Applicable to all arms)

Conditions Studied

Interventions

  • DRUG E-CEL UVEC

Study Locations (1)

New York

  • Weill Cornell Medical College - NewYork-Presbyterian Hospital - New York

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2020-01-22
Est. Completion 2032-06-30
Phase Phase 1

What NCT04190862 shows while recruiting

NCT04190862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 294-participant average among 5 other Anal Fistula trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Anal Fistula appearing as the primary indexed condition, and to 1 intervention - of which E-CEL UVEC is the first listed.

NCT04190862 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT04190862 about?

NCT04190862 is a clinical study titled "E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas". 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 goa...

What is the current status of trial NCT04190862?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2020-01-22. Estimated completion is 2032-06-30.

What conditions does trial NCT04190862 study?

This clinical trial studies the following conditions: Anal Fistula.

What interventions are being tested in trial NCT04190862?

The interventions under investigation include: E-CEL UVEC (DRUG).

Who is sponsoring clinical trial NCT04190862?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04190862 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04190862, the US trial registry maintained by the National Library of Medicine. NCT04190862 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.