Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients

Patients with Covid-19 have a mortality rate of about 35 ~ 50% and currently, severe patients caused by the Coronavirus show respiratory distress. To date, the incidence rate has been more than 3 million each year; however, as the increase and globalization of the environmental pollution has been expanded, the number of patients is expected to increase due to acute diseases such as the Middle East Respiratory virus, SARS, and coronavirus.

Since 2015, Daewoong Pharmaceutical intends to use stem cells for product research on rare and intractable diseases including respiratory distress. Stem cells are also called pluripotent cells or truncal cells that can convert to any organ. It is an embryonic stage undifferentiated cell that has stopped differentiating before forming a specific organ whose differentiation has not been determined and has the ability to differentiate into muscle, bone, and internal conformal body organs. There are three types of stem cells: embryonic stem cells, adult stem cells, and induced pluripotent stem cells. Daewoong Pharmaceutical intends to develop cell therapy products using mesenchymal stem cells (MSC).

Inclusion criteria

• Age of 19 years or older at the time of screening
• Those who have been confirmed COVID-19 infection through PCR test
• Patients with mild or moderate COVID-19 who meet National EWS (0~6)
• Those who have given written consent and voluntarily decided to participate before the screening procedure after understanding the detailed description of the clinical trial.
• Those who are suitable as subjects for this clinical study when judged by physical examination, clinical laboratory test, and other medical examination as stated in the flowchart of protocol.

Exclusion criteria

• Those who have history of hypersensitivity to the components of the investigational product or the reference product
• Those with viral or bacterial pneumonia other than expected indications
• Patients receiving organ transplants within 6 months of screening
• Patients with a history of pulmonary embolism
• Patients who have indications of investigational products as an underlying disease (ex. HIV patients in the clinical study of antiretroviral drugs)
• Patients who are pregnant or lactating
• Those who are determined by the investigator to be unsuitable for participation in the clinical trial due to other reasons including the results of the clinical laboratory test.
• Patients participating in other clinical studies