Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Phase of Trial: Phase III
Latest Information Update: 18 Aug 2017
At a glance
- Drugs PLX PAD (Primary)
- Indications Ischaemia; Peripheral arterial disorders
- Focus Registrational; Therapeutic Use
- Acronyms PACE
- Sponsors Pluristem Therapeutics
- 10 Jul 2017 According to Pluristem Therapeutics media release, this trial has received an $8 million grant from the European Unions Horizon 2020 program
- 10 Jul 2017 According to Pluristem Therapeutics media release, data from all 250 participants will be submitted to the EMA to apply for full marketing approval and will be reviewed by the U.S. FDA for a Biologics License Application (BLA) targeting commercialization.
- 10 Jul 2017 According to Pluristem Therapeutics media release, Austrias regulatory health agency the Austrian Agency for Health and Food Safety (AGES), has cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI).