Clinical study


A severe clinical manifestation of COVID-19 is rapidly developing acute respiratory distress syndrome (ARDS), a serious immune and inflammatory disease characterized by extensive pulmonary inflammation. Since the outbreak of COVID-19 epidemic, multiple studies treating COVID-19 with MSCs have been carried out at home and abroad.


In the US:

FDA Grants IND Approval for Phase II Clinical Trial Using Stemedica’s itMSC Therapy for COVID-19 Patients. This is A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients with Moderate to Severe Lung Injury due to COVID-19. The study will enroll up to 40 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo (lactate ringer solution) plus standard treatment.


Prior to submission of an IND, fourteen critically ill COVID-19 patients were treated on Emergency Use and Expanded Use INDs at the Providence Saint John’s Health Center, (Santa Monica, CA) and ProMedica (Toledo, OH).


The stem cell treatment resulted in an improved clinical course for the patients. Within 24-48 hours of receiving the stem cells, all patients had a significant reduction in oxygen requirements. Several patients went from an inability to talk or eat due to shortness of breath to speaking in full sentences and eating full meals comfortably shortly after treatment.


The study also found improved inflammatory modulation; 88 percent of patients had a significant reduction in acute phase reactants (markers for reductions in inflammation) which resulted in a reduced “cytokine storm.” Researchers noted that these patients experienced quicker extubation, less lung trauma and less oxygen toxicity.


In China:

In February 2020, the company’s research project titled “Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Lung Injuries Caused by COVID-19” received funding from the COVID-19 epidemic prevention and control program under a Daxing Science and Technology Commission initiative.


In the first half of 2020, Jiuzhitang Maker successfully completed the first stage of a pre-clinical study using bone marrow-derived mesenchymal stem cells to treat mice with ARDS (Acute Respiratory Distress Syndrome).