Pluristem: Pioneering Off-the-Shelf Stem Cell Therapies



 
In recent months, 2 patients at the world renowned Hadassah Hospital in Jerusalem, Israel, were suffering from medical conditions that required bone marrow transplants. The lives of a 7-year-old girl and a 54-year-old woman hung in the balance as traditional medical procedures were used to no avail.  In line with Israel's compassionate use policy, and in a final effort to save the lives of their patients, the doctors caring for these patients turned to stem cell developer Pluristem Therapeutics for assistance. In both cases, PLuristem’s PLacental eXpanded cells (PLX) were injected into the patients, and within short periods of time, both patients recovered and were released from the hospital.

Deemed “medical miracles” by the presiding doctor, Professor Reuven Or, MD, director of Bone Marrow Transplantation and Cancer Immunology at Hadassah, these 2 cases serve to remind us of the great medical potential held by stem cell treatments. The ability to develop treatments that can be effectively tailored to the particular needs of a patient or condition is often discussed.  Yet, these discussions are often tempered by either ethical objections to embryonic stem cell use, or the belief that stem cells will be so expensive as to become an exclusive treatment for the wealthy. Pluristem Therapeutics, however, is breathing new life into the promise of stem cell cures by developing affordable treatments that avoid ethical ambiguities.


An Ethical Alternative

While stem cell research has been one of the most controversial medical, scientific, and political topics of the last decade, Pluristem has worked around the issues, blazing new trails in the industry with its unique placenta-derived stem cells. Previously regarded as medical waste, the placenta is home to a large amount of cultivatable cells and, since it is collected after birth, many consider it less ethically objectionable.

Placenta-derived cells became the basis for a technology that allowed Pluristem to develop, what chief executive officer Zami Aberman refers to as “an off-the-shelf stem cell treatment.” Traditionally, stem cells must be matched to donors so they do not react negatively when introduced into the body. However, placental cells are unique in that they can be injected without matching, regardless of the patient's age or gender.

Aberman explains, "Our goal was to find a way to make stem cell treatment more available to a wider population. We understood the potential of stem cells and aimed to make sure that our treatments would be easily accessible to the widest possible audience."

This desire to develop greater accessibility to stem cell treatments also pushed Pluristem to utilize an intramuscular (IM) delivery system as opposed to the more common Intravenous (IV) method. Utilizing an IM delivery simplifies the use of PLX cells, greatly reduces the peripheral equipment required, and allows the administration of PLX cells in almost any environment.
 
 
Unique Manufacturing

Beyond providing a potential treatment for a range of serious illnesses, Pluristem has developed a technology that may have unlocked the future for stem cell manufacturing in the pharmaceutical industry.

Pluristem has pioneered a 3-D manufacturing technology that allows for greater efficiency in production, yielding a larger magnitude of cells in every production cycle for a wider range of treatments. The Company’s proprietary 3-D manufacturing technology can create enough PLX cells, to treat 10,000 patients from just 1 placenta.
 
In terms of efficiency, Pluristem’s manufacturing technology allows the company to reduce manpower and material costs while achieving high output numbers compared with normal industry standards. More importantly, the technology also creates a greater degree of consistency in the stem cells themselves. In this way, Pluristem is able to develop a larger number of cells and guarantee a level of uniformity that has been difficult to achieve with pre-existing methods. Essentially, Pluristem found a way to streamline stem cell production to the extent that making a widely accessible 'off-the-shelf' treatment is within reach.



Clinical Trials

With these technological advantages, Pluristem has surged forward with a series of treatments for a wide range of conditions. Following the ompany’s commitment to make stem cell solutions available to the widest possible audience, multiple treatments are currently undergoing clinical trials with FDA, EMA, PEI (Germany), Israel Ministry of Health, and Indian Ministry of Health.
 
PLX cells could help recover bone marrow. According to Reuters, the company has already submitted an Orphan Drug application with the FDA to treat aplastic anemia.

Tests for critical limb ischemia, a disease that affects over 2.5 million Americans, have already passed Phase I/II testing in the United States and Europe. The company has been approved by the FDA for a Phase II study in intermittent claudication and is also in talks with the FDA and other international regulatory agencies to enter into Phase III trials for Buerger's disease. Additionally, the Indian Ministry of Health has approved a Phase II trial for Buerger's disease, and the PEI has approved Phase I/II trials for muscle injuries related to hip replacements.

While the progress of these treatments is impressive in its own right, it is the constant potential for innovation that puts Pluristem in an ideal position for continued growth. When asked about other potential uses of PLX cells, Aberman noted, “Even though we are focused on our current range of treatments, we are well aware of the tremendous breadth of potential applications. The success of our PLX cells in a multitude of different scenarios, including the experimental uses at Hadassah, show that what we have today is likely just the tip of the iceberg.”

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