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Israeli Cell Therapy Receives FDA Approval to Be Tested on Severely Ill COVID-19 Patients

[additional-authors]
May 8, 2020
Israeli Fire Department crew spray disinfctants as they sanitize a drive trough site on March 20, 2020 in Tel Aviv, Israel. Number of coronavirus in Israel continues to jump, after over 200 new cases have been diagnosed with COVID-19 in the past 24 hours. (Photo by Amir Levy/Getty Images)

Israeli medical company Pluristem Therapeutics announced in a May 8 press release that its cell therapy treatment has received approval from the Food and Drug Administration (FDA) to be tested on severely ill COVID-19 patients in the United States.

The treatment involves using placental expanded cells (PLX) to counteract an overactive immune system response from COVID-19 that can result in pneumonia. It will be used on 140 U.S. patients over a period of 28 days who “are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS [Acute Respiratory Distress Syndrome] due to COVID-19,” according to the press release.

“We look forward to working with hospitals and physicians on a larger scale to deliver our PLX cells, through an off-the-shelf, easy to use PLX cell product candidate, which may potentially accelerate recovery time from life threatening conditions, and to improve survival, in the most severe COVID-19 cases,” Pluristem CEO and president Yaky Yanay said in a statement.

In April, Pluristem announced that its treatment was used on seven Israeli patients suffering from ARDS as a result of COVID-19 complications; six patients completed seven days of treatment and four of those patients saw their conditions improve.

Earlier in the week, Israeli Defense Minister Naftali Bennett announced that the Israeli Institute for Biological Research has developed several antibodies that can be used to attack and neutralize the virus from infected cells in the human body.

“This is an important milestone, which will be followed by a series of complex tests and a process of regulatory approvals,” Bennett tweeted.

As of this writing, there are 16,409 confirmed COVID-19 cases and 245 deaths from the virus in Israel.

H/T: Jerusalem Post

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