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Clinical Trial 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.


Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, dose-ranging, multicenter, phase IIb clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant CVU. The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank. Patients will be randomized to be treated with allo-APZ2-CVU (dose 1, dose 2, dose 3) or placebo (50 patients per dose group). The patients will undergo treatment with the IMP on Day 0 (V3) and will be followed up for efficacy for 18 weeks (V4 until V14). Two safety follow-up visits will be performed at Month 6 (V15) and Month 10 (V16). An additional visit (V17) will be performed to follow up on target wounds of all patients who reached the primary endpoint (i.e. wound was closed at V13 and V14) at Month 16 (at least). The wound healing process will be documented by standardized photography. The wound size measurement will start at the first Screening Visit (V1) and will be measured at each following on-site visit. Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04971161
Study type Interventional
Source RHEACELL GmbH & Co. KG
Contact Christoph Ganss, Dr.
Phone +49 6221 71833
Email office@rheacell.com
Status Recruiting
Phase Phase 2
Start date August 18, 2021
Completion date June 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT01913704 - Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers N/A
Completed NCT03257098 - Allogeneic ABCB5-positive Stem Cells for Treatment of CVU Phase 1/Phase 2
Terminated NCT02742844 - Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers Phase 1/Phase 2
Terminated NCT02307448 - Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds N/A