BIOTECHNOLOGY
Yaky Yanay in the lab
PLX cell therapies in preventing and treating medical conditions caused during space missions, including indications relating to blood, bone, muscle, brain and heart. “T e use of placental cells allows us to
Pluristem’s cleanroom facilities
cell therapies in preventing and treating medical conditions caused during space missions. As Yaky Yanay, CEO at the company, explains, astronauts involved in long-term space exploration missions are forced to operate in a very challenging environment, and are exposed to the harmful eff ects of radiation and microgravity, leading to muscle and bone loss – as well as other potentially serious medical conditions. In an eff ort to address these problems, Pluristem is currently working with NASA on the T erapeutic Stromal Cells for Health in Space project, which has been selected to pre-clinically evaluate the potential of the company’s
benefi t from a biologic resource which is rich and diverse, pro-angiogenic and immunoregulatory. T e cells’ ability to react to signals from the patient’s body is a great advantage, leading to a customised solution in an off -the-shelf product, which encourages the body to regenerate and actually heal itself,” says Yanay. T e latest project is based on previous studies carried out by Pluristem, which demonstrated that placenta expanded (PLX) cells have the potential ability to help regenerate muscles, as well as protect and regenerate the haematological system following exposure to radiation. According to Yanay, a study testing the company’s cell therapy product for muscle regeneration following total hip replacement surgery showed a ‘signifi cant increase of 500% in muscle strength in a patient treated with the cell therapy product compare to placebo – and a signifi cant improvement in muscle volume of approximately 300% over the placebo group.’ “An improvement in muscle force was even found in the contralateral – non-
operated – leg, suggesting that Pluristem’s cells can exert a systemic as well as a local eff ect. A phase 3 study is currently ongoing in the USA., EU and Israel,” he says.
As far as radiation exposure is concerned, Yanay is keen to stress that effi cacy studies are not permitted in humans, meaning that studies are currently conducted via the FDA animal rule pathway. Here, he reveals that a series of studies conducted by the US government to test the company’s cells as treatment for Acute Radiation Syndrome (ARS) have shown a ‘statistically signifi cant improvement in the survival rate and recovery of blood cell production in animals exposed to high levels of radiation.’ “Safety data showed that the cells did not aff ect non-irradiated animals,
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