Pluristem's PLX-PAD cleared in EU

Pluristem Therapeutics, a US biotherapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy  products for a variety of disorders, has received a declaration from  Biotec Services International stating that its investigational medicinal  product, PLX-PAD, has been manufactured in accordance with standards of  Good Manufacturing Practice, equivalent to those applied in the European  Union.

Biotec Services is an international clinical trials supply company  providing release services of the IMP into the European Union.

Upon clearance by regulators, Pluristem plans to initiate clinical  trials in Europe and the USA, administering PLX-PAD to patients  afflicted with critical limb ischemia, which has not responded to  traditional medical or surgical interventions.