A Phase II Study in Patients with Moderate to Severe ARDS Using GMP, Allogeneic, Bone Marrow-Derived, Ischemic-Tolerant Mesenchymal Stem Cells
SAN DIEGO, Aug. 5, 2021 /PRNewswire/ -- 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).
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of progenitor cell, protein and combination therapeutics for underserved medical conditions. Stemedica has developed a proprietary manufacturing technology platform that produces allogeneic progenitor cell products with intellectual property protection under a low-oxygen, low-tension environment in a cGMP-compliant manufacturing facility. The company's lead drug candidate, ischemia-tolerant mesenchymal stem cells, or itMSCs, is an allogeneic progenitor cell therapy currently in clinical development for the treatment of COVID-19, ischemic stroke and Alzheimer's disease. More information on Stemedica may be found at www.stemedica.com.
Forward Looking Statements
This press release may contain forward-looking statements. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
Stemedica Cell Technologies, Inc.
View original content to download multimedia:https://www.prnewswire.com/news-releases/stemedica-opens-enrollment-in-phase-ii-clinical-trial-for-covid-19-301348836.html
SOURCE Stemedica Cell Technologies, Inc.