Phase II trial in Japan of PLX PAD in patients with critical limb ischaemia.
Phase of Trial: Phase I/II
Latest Information Update: 10 May 2016
At a glance
- Drugs PLX PAD (Primary)
- Indications Peripheral arterial disorders
- Focus Adverse reactions; Therapeutic Use
- 10 May 2016 According to a Pluristem media release, the company anticipates that data from this trial will lead to conditional marketing approval for PLX-PAD in the treatment of Critical Limb Ischemia in Japan.
- 10 May 2016 According to Pluristem media release, Japan's Pharmaceuticals and Medical Devices Agency has cleared the protocol for this trial.
- 21 Dec 2015 According to Pluristem media release, Pluristem expects to submit the formal Clinical Trial Notification (CTN) to the PDMA, based on the agreement reached with the regulatory body, in early 2016.