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01
Overview
Phase 2, open-label, single-arm trial of EBESANAR in venous leg ulcer (VLU), sponsored by RHEACELL. Primary endpoints: Percentage of wound size reduction at 12 weeks and Assessment of adverse event (AE) occurrence at 12 months. Started Aug 2016; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
APZ2 application
Single topical application of autologous ABCB5+ MSCs
03
Who it enrols
Adult patients with therapy-resistant chronic venous leg ulcers (duration 6 weeks to 3 years) and wound size 5-50 cm2.
04
Endpoints
Primary
Percentage of wound size reduction
Assessment of adverse event (AE) occurrence
Secondary
Percentage of wound size reduction
Absolute wound size reduction
Proportion of patients achieving complete wound closure
Time to first complete wound closure
Proportion of patients achieving 30% wound closure
Time to first 30% wound closure
Percentage of wound epithelialization
Formation of granulation tissue and wound exudation
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