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: 17 Jan 2018
At a glance
- Drugs PLX PAD (Primary)
- Indications Ischaemia; Peripheral arterial disorders
- Focus Registrational; Therapeutic Use
- Acronyms PACE
- Sponsors Pluristem Therapeutics
- 18 Sep 2017 According to a Pluristem Therapeutics media relase, the US FDA has granted Fast Track designation for this phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia.
- 18 Sep 2017 According to a Pluristem Therapeutics media release, the European Medicines Agency (EMA) has included PLX-PAD in its Adaptive Pathways program. Positive results from an interim analysis following treatment of half (125) of the study's population may lead to early conditional marketing authorization.
- 11 Sep 2017 According to a Pluristem Therapeutics media release, a company is expecting to have 40 active sites worldwide by the end of 2017.