Connie K. Ho for redOrbit.com Your Universe Online
20,000,000. This is the number of peripheral artery disease patients Pluristem Therapeutics, a placenta-based cell therapy company, is working to assist. The company recently released information regarding the effectiveness of cell therapy with intramuscular delivery.
To begin, Pluristem uses stem cells from the human placenta and has created a manufacturing process that produces enough cells to treat 10,000 patients from one placenta.
You usually have to match cells to donors so they do not react. Placental cells are unique because they come from a unique section that combines the mother and the baby. They can be injected without no question age or sex, remarked Zami Aberman, Chairman and CEO of Pluristem.
PLacental eXpanded, otherwise known as PLX, cells release a mix of therapeutic proteins to target local and systemic inflammatory diseases. The cells are developed with 3D micro-environmental technology that doesnt require tissue matching before administration. Unlike other cell therapies that are conducted with intravenous injections, the Pluristem treatment includes intramuscular injections that are injected with a needle into the muscle.
The cells are grown in 3D and not in human. With [this] technology we give them more natural place, grown in better way, produced in an efficient way to become an official product, stated Aberman.
Researchers believe that intravenous treatments will allow them to have a greater variety of possible outpatient settings and local clinics.
The ability for IM injections of PLX cells has significant market implications that potentially broaden the indications and frequency with which our cell therapy can be used. We look forward to conducting additional testing of this very promising approach, commented Aberman in a prepared statement.
The company recently received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase II clinical trial for the PLX-PAD cells, which can treat a type of peripheral artery disease known as Intermittent Claudication (IC),which causes pain when walking.
One thing to mention about the study is it is the first time given to patients with other options, noted Aberman. Its important to mention as the FDA recognized that the safety profile of the PLX in phase one was good and promising enough to move to patients who are in less severe conditions.
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Pluristem Focuses On Therapeutic Cells Delivered Intramuscularly