Mass production of placenta stem cells gets FDA approval …

Published time: March 10, 2014 22:34

Reuters/Wolfgang Rattay

The US Food and Drug Administration has granted approval to Pluristem Therapeutics to mass produce therapeutic human-placenta-derived stem cell products within its commercial-scale manufacturing facility in Haifa, Israel.

Pluristems Placental Expanded (PLX) products are mesenchymal-like adherent stromal cells connective tissue cells in an organ from human placentas, which are lush with hormones and proteins. The FDA has cleared PLX for use in studies on treating injuries, one step closer to full approval of PLX cells in treatments.

PLX products are made via Pluristems automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment.

The PLX cells are grown using the companys proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching prior to administration, according to Pluristem.

Pluristem operates out of a high-output facility in northern Israel that can produce about 150,000 doses of PLX products a year.

"We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies," Zami Aberman, chairman and CEO of Pluristem, said in a statement. "Knowing that the 'Process is the Product' in cell therapy, we have established our leadership position in the industry by focusing on our 3D commercial scale cell manufacturing processes.

Pluristems use of human placenta to boost cell repair involves a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases.

Though animal placenta, especially from horses, has been a popular form of treatment for cell repair, human placenta offers a naturally compatible genome.

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Mass production of placenta stem cells gets FDA approval ...