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news.Pluristem Therapeutics, a bio-therapeutics company, has filed an investigational medicinal product dossier application with the Paul Ehrlich Institute, the German competent authority in the EU, to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia.
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Assuming approval of the investigational medicinal product dossier (IMPD) by this authority, Pluristem plans to initiate the dose ranging clinical trial during the second quarter of 2009 at two sites in Berlin, Germany.
The patient population for this initial clinical trial will be considered ‘late stage’, defined as patients whose limb ischemia has not responded to traditional medical or surgical interventions and who are facing amputation.
Pluristem also plans to file shortly an investigational new drug application with the Center for Biologics Evaluation and Research at the FDA, for a similar trial to take place in two US clinical centers.
Results of preclinical studies in animal models whose limbs were rendered ischemic, using intramuscular administration of PLX-PAD, have shown a statistically significant increase in blood flow and formation of new blood vessels (angiogenesis), the company said.
Zami Aberman, president and CEO of Pluristem, said: Our primary goal for this trial, as well as for the one we will begin in the US, is to prove PLX-PAD is safe. If we are successful in this endeavor, it will have been the first time adult stem cells, derived from placenta and grown using our PluriX 3D technology, have been administered to humans safely.
We believe successful trials in Europe and the US herald the dawn of a new era in the evolving industry of cellular therapeutics being able to administer an allogeneic, off-the-shelf product that needs no matching.