NCT04971161

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

Completed Phase 2 Last updated 4 December 2025

What this trial tests

Phase 2 trial testing allo-APZ2-CVU in Skin Ulcer Venous Stasis Chronic in 159 participants. Completed in 25 November 2025.

Timeline

18 August 2021

Primary endpoint
25 November 2025

25 November 2025

Quick facts

Lead sponsor	RHEACELL GmbH & Co. KG
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	159
Start date	18 August 2021
Primary completion	25 November 2025
Estimated completion	25 November 2025
Sites	38 locations across Germany

Drugs / interventions tested

• allo-APZ2-CVU — full drug profile →
• Placebo

Conditions studied

• Skin Ulcer Venous Stasis Chronic — all drugs for Skin Ulcer Venous Stasis Chronic →

Sponsor

RHEACELL GmbH & Co. KG — full company profile →

Who can join

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

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-Term Protective Effect of Human Dystrophin Expressing Chimeric (DEC) Cell Therapy on Amelioration of Function of Cardiac, Respiratory and Skeletal Muscles in Duchenne Muscular Dystrophy.
   Siemionow M, Langa P, Brodowska S, Kozlowska K, et al · · 2022 · cited 15× · PMID 35590083 · DOI 10.1007/s12015-022-10384-2
2. Skin-Derived ABCB5⁺ Mesenchymal Stem Cells for High-Medical-Need Inflammatory Diseases: From Discovery to Entering Clinical Routine.
   Niebergall-Roth E, Frank NY, Ganss C, Frank MH, et al · · 2022 · cited 13× · PMID 36613507 · DOI 10.3390/ijms24010066
3. Long-Term Biodistribution and Safety of Human Dystrophin Expressing Chimeric Cell Therapy After Systemic-Intraosseous Administration to Duchenne Muscular Dystrophy Model.
   Siemionow M, Brodowska S, Langa P, Zalants K, et al · · 2022 · cited 12× · PMID 35978142 · DOI 10.1007/s00005-022-00656-7
4. 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
5. The Differentiation and Regeneration Potential of ABCB5⁺ Mesenchymal Stem Cells: A Review and Clinical Perspectives.
   He Z, Starkuviene V, Keese M. · · 2025 · PMID 39941329 · DOI 10.3390/jcm14030660