Pluristem Focuses On Therapeutic Cells Delivered Intramuscularly
July 21, 2012

Pluristem Focuses On Therapeutic Cells Delivered Intramuscularly

Connie K. Ho for — 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.

“Usually, cells have to be matched to donors so they do not react negatively. Placental cells are unique because they come from a unique section that connects the mother and baby. They can be injected without question of age or sex of the patient,” 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 doesn´t 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 a 3D bioreactor and not in humans. With [this] technology“¦ we are able to efficiently grow a large number of cells in a natural way to produce our treatments,” 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 the 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.

“The cells are grown in a 3D bioreactor and not in humans. With [this] technology“¦ we are able to efficiently grow a large number of cells in a natural way to produce our treatments,” stated Aberman.

For the Phase II study of PLX-PAD cells on the treatment of IC, the company is partnering with CPC Clinical Research in enrolling and continuing clinical sites.

“Research into cell-based therapies represents an exciting new strategy to manage patients with disabling peripheral artery disease.  Our collaboration with Pluristem and their scientific steering committee has been excellent, ensuring a high quality trial to test this new cell product,” remarked Dr. William R. Hiatt, President of CPC Clinical Research and Professor of Medicine University of Colorado, Anschutz Medical Campus, in a prepared statement.

Another study with the Sharett Institute of Oncology at Hadassah Hospital in Jerusalem discovered that PLX cells administered intramuscularly offer therapeutic benefits for different hematological disorders, primary and secondary bone marrow failure, as well as in issues related to chemotherapy and radiotherapy. The findings showed that there is a significant recovery and survival rate for bone marrow and peripheral blood counts by stimulating hematopoietic stem cells (HSCs) of the bone marrow to produce red and white blood cells along with platelets needed for treating hematological disorders.

“Pluristem is extremely pleased at how convincingly this study´s data demonstrates that our PLX cells have the ability to stimulate the HSCs involved in rescuing bone marrow. With PLX cells, we may be able to reverse the traditional mindset that if you want to get a systemic effect, you need to inject the cells intravenously,” noted Dr. Liat Flaish, director of the Radiation project at Pluristem, in the statement.

In the past, Pluristem has also received a $3.1 million grant from the Israeli government to support other research and development as well as clinical trials.

In one particular situation that showcases the efficacy of the treatment, a seven-year-old girl was given the PLX cells following two failed bone marrow transplants. The girl applied to the Israel authority for compassionate use. Once her application was approved, she received injection of cells and recovered two months after the treatment. It demonstrated the impact of the treatment with other diseases that are related to bone marrow.

“The girl was suffering from a rare disorder connected to aplastic bone marrow, her blood system could not function well, she couldn´t produce white cells, red cells, platelets—we recovered her in normal condition and managed to boost donor and meta stem cells, generating a situation where those organ donor cells were producing enough cells to keep her alive,” explained Aberman. “Sometimes you need the right place, the right time and the right product. Physicians using conventional treatment couldn´t find other ways to treat her.”