The study, in which 140 patients will be treated, is randomized, double-blind, with a placebo-treated control group designed to test the effectiveness and safety of intramuscular injections of PLX-PAD for the treatment of severe cases of COVID-19 complicated by respiratory obstruction
The Israeli biotechnology company Pluristem announced yesterday (Thursday) the activation of clinical sites and the start of the recruitment of patients for a phase II trial according to a protocol approved by the US Food and Drug Administration (FDA) that will test the effect of PLX cells in the treatment of corona patients suffering from acute respiratory distress (ARDS) ). The company focuses on increasing the number of clinical sites across the US in accordance with the dynamic and changing spread of the COVID-19 epidemic. The experiment is expected to encompass up to 25 sites.
The study, in which 140 patients will be treated, is randomized, double-blind, with a placebo-treated control group designed to test the effectiveness and safety of intramuscular injections of PLX-PAD for the treatment of severe cases of COVID-19 complicated by ARDS. The main parameter for determining the success of the study is the number of days without the need for a ventilator during the 28-day study period. Follow-up tests to assess safety and survival will take place at week 8, 26 and 52. The secondary parameter for determining the success of the study in terms of effectiveness includes mortality rates from any cause, duration of mechanical ventilation, days without intensive care hospitalization and days without hospitalization at all.
Yaki Yanai, president and CEO of Pluristem, said today: "Pluristem is closely monitoring the spread of COVID-19 in the world, as well as the concentrations of infection in the US. We are targeting sites with the highest rate of new infection cases and combining the benefits of our PLX-PAD candidate into a ready-to-use product. Pluristem's unique logistical capabilities, which rely on a cryogenic (nitrogen) supply chain, allow us to treat patients within a few hours of receiving the notification. We believe that this will allow us to provide treatment for the COVID-19 virus at the right time and place and help the health systems in their fight against COVID-19, its complications and the burden it places on the medical infrastructure."
One response
It's a shame that an important site like the scientist promotes a company with a history of failures and defrauding investors. Until recently there was no doctor or medical scientist in the management of the company. A financial loophole for its own sake. There has been no clear scientific evidence of stem cell technologies for 30 years! There is a cynical exploitation of a crisis and health uncertainty to raise more money from the public.