Last week, Pluristem released initial results from its compassionate use program for the treatment of patients with acute respiratory failure and inflammatory complications resulting from COVID-19. The treatment was administered in an Israeli hospital. All seven ICU patients with ARDS treated with Pluristem’s PLX cell therapy have survived. 6 out of 7 have completed the seven-day follow-up (one is still within the period. 4 out of the 6 (66%) patients displayed improvement in respiratory parameters, and 3 of the 6 (50%) patients are in late stages of weaning from ventilators.
Pluristem has now treated its first COVID-19 patient in the United States. under the FDA’s Single Patient Expanded Access Program, also called a compassionate use program, which is part of the U.S. Coronavirus Treatment Acceleration Program (CTAP.) The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s Phase III critical limb ischemia (CLI) study. Prior to treatment with PLX, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation in an intensive care unit (ICU) for three weeks.
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering an advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. PLX cells may reduce the incidence and\or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. This is a potential therapy for mitigating the tissue-damaging effects of COVID-19.