The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
Summary
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial
conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to
assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of
REX-001 or matching placebo into the index limb.
Phase:
Phase 3
Details
Lead Sponsor:
Ixaka Ltd Rexgenero Limited
Collaborators:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud Andalusian Network for Design and Translation of Advanced Therapies