USFDA clears Plursitem for expanded access program

Patients suffering from critical limb ischemia can now benefit without being part of clinical trials

January 10, 2018 16:48
1 minute read.
A Pluristem scientist in the process of making its cell products and a look at the final product its

A Pluristem scientist at work.. (photo credit: PLURISTEM)


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The US Food & Drug Administration has cleared Pluristem Therapeutics’ Expanded Access Program for the use of its PLX-PAD cell treatment in patients with critical limb ischemia.

The Haifa-based firm’s patented PLX-PAD placental cell therapy – which encourages the secretion of a range of therapeutic proteins and includes the growth of blood vessels and delivering oxygenated blood to damaged tissue to encourage the body to trigger its own repair mechanisms – will be made available to a limited number of Rutherford Category 5 critical limb ischemia (CLI) patients (those in danger of losing a limb due to non-healing ulcers and gangrene) in the US, who are unsuitable for vascularization and cannot take part in the company’s ongoing Phase III clinical study.

Pluristem’s PLX-PAD program has already been selected for accelerated approval in the FDA’s Fast Track Designation and the European Medicines Agency’s Adaptive Pathways program.

“This is a true vote of confidence by the FDA in our cell therapy and a landmark achievement for Pluristem,” said Yaky Yanay, co-CEO and president of Pluristem. “It gives us the ability to begin treatments using our cell product, offering treatment to certain CLI patients who have poor therapeutic options, while also collecting real-world data alongside our ongoing Phase III clinical study.”

The FDA’s decision may also entitle Pluristem to be compensated for the costs of treatment, which could then be reinvested into further research in developing effective cell therapies with the potential to aid millions of patients worldwide.

This article was written in cooperation with Pluristem Therapeutics.

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