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The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Ulcers in Subjects with Critical Limb Ischaemia Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial

Trial Profile

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Ulcers in Subjects with Critical Limb Ischaemia Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Rexmyelocel T (Primary)
  • Indications Chronic limb-threatening ischemia; Ulcer
  • Focus Registrational; Therapeutic Use
  • Acronyms Salamander
  • Sponsors Ixaka
  • Most Recent Events

    • 23 Jul 2023 This study has been completed in Netherlands, according to European Clinical Trials Database record.
    • 29 Jun 2023 This trial has been completed in Czechia and Lithuania (End Date: 02 May 2023), according to European Clinical Trials Database record.
    • 14 Mar 2023 Status changed from active, no longer recruiting to discontinued.
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