Skin Ulcer Venous Stasis Chronic Clinical Trial
Official title:
An Interventional, Single Arm, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of APZ2 on Wound Healing of Chronic Venous Ulcer (CVU)
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.
This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy
and safety of ABCB5+ mesenchymal stem cells (MSCs) on wound healing in patients with chronic
venous ulcer (CVU). Autologous MSCs will be isolated ex vivo from a small skin biopsy and
will be expanded in vitro. The IMP APZ2 containing the ABCB5+ cells will then be applied on
the wound surface of CVU under local anesthesia.
Patients are followed up for efficacy for 3 months which allows to distinguish actual wound
healing from transient wound coverage.
The wound healing process will be documented by standardized photography. The wound size
evaluation will start on the day of the first change of wound dressing. The quality of the
wound healing process will be assessed on the basis of formation of granulation tissue,
epithelialization and wound exudation.
Pain will be assessed using a numerical rating scale and quality of life will be investigated
with standardized and validated questionnaires. To assess long-term safety of APZ2 an
additional follow-up visit at Month 12 post IMP application is included.
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