Japan's Rohto Pharmaceutical said Tuesday it plans to launch clinical trials in August for a stem cell-based treatment for patients suffering severe symptoms induced by the novel coronavirus.
The Osaka-based drugmaker looks to verify the safety and effectiveness of the remedy by December 2021 when the tests will close, then quickly put it on the market.
The trials will target COVID-19 patients who have been put on ventilators due to pneumonia-like symptoms. Such a critical state can lead to a complication known as a cytokine storm -- a deleterious autoimmune response to the respiratory virus.
Each patient will receive about 100 million mesenchymal stem cells per dose, which will be administered intravenously. The stem cells, which are found in bone marrow and umbilical cords, are expected to arrive at the affected areas of the lungs where they will suppress the inflammation and the autoimmune response.
Six patients, mainly from Osaka University Hospital, will take part in the trials. Rohto will administer four doses of stem cells to each subject, then observe the effectiveness over two months.
Rohto has developed equipment that automatically cultures mesenchymal stem cells initially harvested from a donor's fatty tissue. The technology is capable of growing roughly 180 billion stem cells over a year, enough to treat about 450 people.