A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Phase III Study to Evaluate the 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 (PACE Study)
Phase of Trial: Phase III
Latest Information Update: 19 Mar 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.