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news.Pluristem Therapeutics has selected Cato Research as its contract research organization (CRO) for the German portion of the Company's Phase II trial in intermittent claudication (IC) under the supervision of the Paul-Ehrlich Institute (PEI).
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IC is a subset of PAD caused by atherosclerosis of the lower extremity arteries and is characterized by muscle pain, such as aching, cramping, numbness.
The trial will evaluate the safety and efficacy of Pluristem’s PLacental eXpanded (PLX-PAD) cells in treating IC, a subset of peripheral artery disease (PAD).
Pluristem’s multinational phase II trial in IC will also include 11 sites in the US and 2 sites in Israel and will enroll 150 patients in a randomized, double blinded, placebo controlled study.
The primary focus of the trial will be maximum walking distance achieved on a treadmill at 12 months.
Pluristem chairman and CEO Zami Aberman said IC afflicts approximately 14 million people in the US alone.
”If we are successful in our trials, our proprietary 3D technology for manufacturing our PLX-PAD ‘off-the-shelf’ product will enable us to meet the demand to treat such a large population of patients across the world," Aberman added.
Cato will serve as Pluristem applicant to the PEI and to the ethics committees of the three study sites where the trials will be held.