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Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)

NCT04971161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-12-04

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events \[AEs\]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to placebo.

Conditions

  • Skin Ulcer Venous Stasis Chronic

Interventions

BIOLOGICAL

allo-APZ2-CVU

Suspension of ABCB5-positive dermal mesenchymal stromal cells. One topical application with a syringe.

DRUG

Placebo

One topical application with a syringe

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • RHEACELL GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Andreas Kerstan, Dr. · Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2025-11-25
Completion
2025-11-25

Countries

  • Germany

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 NCT04971161 on ClinicalTrials.gov