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NCT06489028 · ClinicalTrials.gov registry record · Phase 3

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)

A Phase 3 study of Venous Leg Ulcer, sponsored by RHEACELL GmbH & Co. KG.

Active
Registry status
Phase 3
Development phase
250
Enrollment target
15
Study locations

NCT06489028 is a Phase 3 study of Venous Leg Ulcer that is active but no longer recruiting, run by RHEACELL GmbH & Co. KG. The registered enrollment target is 250 participants, roughly in line with the 238-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target. The trial reports 15 study locations across 4 states.

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The verdict

NCT06489028, a Phase 3 study of Venous Leg Ulcer, is active but no longer recruiting, sponsored by RHEACELL GmbH & Co. KG.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
250 participants
Enrollment target
15
Study locations

Study Summary

The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.

Conditions Studied

Venous Leg Ulcer

Interventions

  • DRUG Placebo
  • DRUG allo-APZ2-CVU

Study Locations (15)

Other

  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Several Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations
  • RHEACELL Clinical Trial Site - Multiple Locations

Florida

  • RHEACELL Clinical Trial Site - Hialeah
  • RHEACELL Clinical Trial Site - Miami

Massachusetts

  • RHEACELL Clinical Trial Site - Boston

Minnesota

  • RHEACELL Clinical Trial Site - Minneapolis

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2024-12-26
Est. Completion 2027-09
Phase Phase 3

Sponsor

RHEACELL GmbH & Co. KG

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06489028

The ClinicalTrials.gov registry entry for NCT06489028 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 238-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target. The listed sponsor is RHEACELL GmbH & Co. KG, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Leg Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06489028 reports 15 study locations spanning 4 distinct geographic areas - top geographies include Other, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06489028 about?

NCT06489028 is a clinical study titled "Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)". The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.

What is the current status of trial NCT06489028?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2024-12-26. Estimated completion is 2027-09.

What conditions does trial NCT06489028 study?

This clinical trial studies the following conditions: Venous Leg Ulcer.

What interventions are being tested in trial NCT06489028?

The interventions under investigation include: Placebo (DRUG), allo-APZ2-CVU (DRUG).

Who is sponsoring clinical trial NCT06489028?

This trial is sponsored by RHEACELL GmbH & Co. KG, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06489028 being conducted?

This trial has 15 study locations across Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.