Skin Ulcer Venous Stasis Chronic Clinical Trial
Official title:
An Interventional, Single Arm, Multicenter, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU 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 of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the medicinal product to be studied after two applications on the wound surface in patients with Chronic Venous Ulcers.
This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy
and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in
patients with chronic venous ulcer (CVU). Allogeneic MSCs will be isolated ex vivo and will
be expanded in vitro. The IMP incorporating the ABCB5-positive MSCs will then be applied on
the wound surface of CVU under local anesthesia (on Day 0 and Week 6.1).
Wound measurements from Visit (V) 2 and V9 will be used to determine the cell amount for the
IMP treatments on V3 and V10, respectively.
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 allo-APZ2-CVU
three follow-up visits at Months 6, 9 and 12 after the first IMP applications are included.
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