The Efficacy and Safety of Intra-arterial Administration of Rexmyelocel-T to Treat Ischemic Ulcers in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial
Phase of Trial: Phase III
Latest Information Update: 31 May 2018
At a glance
- Drugs Rexmyelocel T (Primary)
- Indications Peripheral ischaemia
- Focus Registrational; Therapeutic Use
- Sponsors Rexgenero
- 25 Jan 2018 According to a Rexgenero media release, the trial design including the patient population and primary endpoints, have been fully endorsed by the European Medicines Agency (EMA).
- 23 Nov 2017 This trial has been suspended in Spain.
- 14 Nov 2017 This trial has been suspended in Austria.