Pluristem, an Israeli based company, treated its first American patient suffering from COVID-19 complications under the country’s compassionate use program, the Jerusalem Post reported.
Several days ago, the company reported that six critically ill high-risk for mortality coronavirus patients in Israel were treated with Pluristem’s therapy and survived.
The U.S. patient was treated at Holy Name Medical Center in New Jersey, where Pluristem is already running a Phase III study. The patient was critically ill with respiratory failure due to acute respiratory distress syndrome and was intubated in an intensive care unit for three weeks.
Yaky Yanay, the president and CEO of Pluristem, said that although the company is focused on a planned multinational clinical trial, it does hope to expand treatment under compassionate use in other countries at the same time.
“We are pleased with this initial outcome of the compassionate use program and committed to harnessing PLX cells for the benefit of patients and healthcare systems,” Yanay said.
The single U.S. treatment was administered under the US Food and Drug Administration’s Single Patient Expanded Access Program, which is part of the US Coronavirus Treatment Acceleration Program. The emergency program is aimed at getting treatments to corona patients as quickly as possible.
Six patients in Israel, suffering from acute respiratory failure and inflammatory complications associated with COVID-19, were treated under a compassionate use program at three different Israeli medical centers for one week. Four of the six patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure.
All of the patients survived one week later, according to Pluristem, with four of them showing improvement in respiratory parameters, and three are in the advanced stages of weaning from ventilators. Two of the patients with preexisting medical conditions are showing clinical recovery in addition to the respiratory improvement.
“Pluristem shows the COVID-19 world the first clinical data for stem cells,” Dr. Jason McCarthy, a senior managing director covering the biotechnology industry at Maxim Group, wrote.