Stemedica Opens Enrollment in Phase II Clinical Trial for COVID-19 A Phase II Study in Patients with Moderate to Severe ARDS Using GMP, Allogeneic, Bone Marrow-Derived, Ischemic-Tolerant Mesenchymal Stem Cells

 Stemedica Cell Technologies, Inc. (“Stemedica”), a San Diego-based biotech company specializing in the manufacture of clinical grade stem cells, announces enrollment of patients for its study entitled “A Phase II, 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 ARDS Due to COVID-19.”  The study will enroll approximately 40 subjects.    

“Mesenchymal stem cells (“MSCs”) have immunomodulatory and tissue regenerative properties, secreting anti-inflammatory cytokines, inhibiting monocyte differentiation, and regulating the function and proliferation of immune cells,” said Lev Verkh, PhD, Stemedica’s Chief Regulatory & Clinical Development Officer. “Our data treating severe and critically severe cases suggest that those who received MSCs earlier in their clinical course of disease may have appreciated more benefit; it is possible that earlier treatment may help prevent the cytokine storm, rather than attempting to reverse it.”

Stemedica’s bone marrow-derived, allogeneic ischemic-tolerant mesenchymal stem cells (“itMSCs”) are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing.

In 2020, 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, California) and ProMedica Hospitals (Toledo, Ohio). The stem cell treatment resulted in an improved clinical course of 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 extubating, less lung trauma and less oxygen toxicity.

Recruitment for the current trial is active at two sites: Providence St. Jude Medical Center, Fullerton, CA (Principal Investigator, David Park, MD) and Providence Saint John’s Health Center, Santa Monica, California (Principal Investigator, Santosh Kesari, MD).  More information about this clinical trial including enrollment details, can be found at www.clinicaltrials.gov (NCT04780685).