NCT06489028 is a Phase 3 clinical trial of allo-APZ2-CVU in Venous Leg Ulcer, sponsored by RHEACELL GmbH & Co. KG.

Who is sponsoring NCT06489028?

NCT06489028 is sponsored by RHEACELL GmbH & Co. KG.

What drugs are being tested in NCT06489028?

Interventions in NCT06489028: allo-APZ2-CVU, Placebo.

What condition does NCT06489028 study?

NCT06489028 studies Venous Leg Ulcer.

Is NCT06489028 still recruiting?

NCT06489028 is currently active, enrolled. Last updated 26 September 2025.

Last reviewed 2025-09-26 · How we verify

NCT06489028

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pivotal, Randomized, Placebo-controlled, Double-blind, Multicenter, International Phase III Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Non-Healing Chronic Venous Ulcers (CVU)

Active, enrolled Phase 3 Last updated 26 September 2025

What this trial tests

Phase 3 trial testing allo-APZ2-CVU in Venous Leg Ulcer in 250 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 December 2024

Primary endpoint
1 April 2027

1 September 2027

Quick facts

Lead sponsor	RHEACELL GmbH & Co. KG
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	250
Start date	26 December 2024
Primary completion	1 April 2027
Estimated completion	1 September 2027
Sites	15 locations across United States, Austria, Czechia, France, Germany, Hungary, Italy, Netherlands

Drugs / interventions tested

allo-APZ2-CVU — full drug profile →
Placebo

Conditions studied

Venous Leg Ulcer — all drugs for Venous Leg Ulcer →

Sponsor

RHEACELL GmbH & Co. KG — full company profile →

Who can join

18 and older, any sex, with Venous Leg Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Complete wound closure
Time frame: 18 weeks
Complete wound closure already persisting for at least two weeks

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378

Verify or expand the search:

Other trials of allo-APZ2-CVU

Trials testing the same drug.

NCT04971161 — Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb) · Phase 2 · completed
NCT03257098 — Allogeneic ABCB5-positive Stem Cells for Treatment of CVU · Phase 1, PHASE2 · completed

Other recruiting trials for Venous Leg Ulcer

Currently open trials in the same condition.

NCT07255937 — PMCF Study of Debridement Pad · NA · recruiting
NCT07046767 — CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations · NA · recruiting
NCT07211243 — Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers · NA · recruiting
NCT07061613 — Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers · NA · recruiting
NCT06544564 — Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population · NA · recruiting

Other RHEACELL GmbH & Co. KG trials

Trials by the same sponsor.

NCT04971161 — Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb) · Phase 2 · completed
NCT03860155 — Allogeneic ABCB5-positive Stem Cells for Treatment of Acute-on-Chronic Liver Failure · Phase 1, PHASE2 · terminated
NCT03529877 — Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa · Phase 1, PHASE2 · completed
NCT03339973 — Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD · Phase 1, PHASE2 · terminated
NCT03267784 — Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans" · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06489028 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by RHEACELL GmbH & Co. KG
Last refreshed: 26 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06489028.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing