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The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Rest Pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial

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Trial Profile

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Rest Pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 May 2021

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At a glance

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

    • 05 May 2021 Status changed from recruiting to discontinued.
    • 11 Mar 2021 This trial has been completed in Austria, according to European Clinical Trials Database record.
    • 28 Aug 2018 Planned End Date changed from 30 Dec 2019 to 1 Oct 2020.

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