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

NCT06489028 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-10-01

No results posted yet for this 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

  • Venous Leg Ulcer

Interventions

DRUG

allo-APZ2-CVU

Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • RHEACELL GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Anna Moessmer · RHEACELL GmbH & Co. KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-26
Primary Completion
2027-04-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT06489028 on ClinicalTrials.gov