#AceHealthNews – ISRAEL – 23 March – The US Food and Drug Administration has granted approval http://www.pharmabiz.com/NewsDetails.aspx?aid=80807&sid=2to Pluristem Therapeutics to mass produce therapeutic human-placenta-derived stem cell products within its commercial-scale manufacturing facility in Haifa, Israel.
Pluristem’s 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 Pluristem’s “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 company’s 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. http://on.rt.com/j7qdeo
From the CEO – http://www.pluristem.com/
Our vision at Pluristem Therapeutics inc. is to leverage our position as the global leader in placenta-based cell science to become the world’s leader in developing and manufacturing cell therapy products.
We believe our cutting edge technology can become the standard of care for treating a host of inflammatory and ischemic conditions.
We are in the process of achieving this vision by building a successful, winning team to maintain our standard of excellence in the research, development and production of cell therapies.
We continue to develop our understanding surrounding the mechanism of action of PLacental eXpanded (PLX) cells. We then leverage this understanding towards the development of these cells for additional markets. Currently we are actively pursuing indications in the peripheral vascular, pulmonary, orthopedic, ob-gyn and hematology markets.
We also believe “the Process is the Product.” This reflects our view that the precise control of the entire process, from obtaining cells from the source, to delivery to the patient, is vitally important to the success of a cell therapy product. Part of the reason we are able to obtain this precision in our cell expansion process is our exclusive ability to expand cells via our proprietary 3D technology.
Combining this “Powered by Pluristem” fully automated process with our increasing knowledge of the placental cell is the powerful engine towards identifying additional products for new markets and indications.
Every engine needs a driver, which returns me to the key to success for achieving our vision: the team. Our team has the ability, integrity, commitment and courage to develop breakthrough cell therapies that can transform the treatment of certain diseases and deliver value to our shareholders.
Chairman and CEO