A Call to Action
As you may be aware, Personalized Stem Cells recently received approval to treat COVID-19 patients in a phase 1 clinical trial. When COVID-19 was declared a global pandemic, we immediately felt called to action. With almost two decades’ worth of experience in regenerative medicine, we saw the possibility for supplying potentially life-saving stem cell therapy.
Stem Cells for Acute Respiratory Distress Syndrome
Scientists have studied stem cell therapy to treat an array of conditions including acute respiratory distress syndrome (ARDS). ARDS is a serious lung condition that can result from a variety of causes such as infection (like COVID-19) or environmental factors. It is typically characterized by an acute inflammatory response which leads to fluid buildup in the lungs and ultimately low blood oxygen levels. ARDS may lead to long term complications or death.
When administered intravenously, mesenchymal stem cells (MSCs) sequester in the lungs. MSCs have demonstrated the ability to down regulate inflammation and inhibit lung fibrosis. Additionally, MSCs have been shown to aid in the clearance of fluid from the lungs and lead to lung tissue regeneration. These, among other mechanisms of action, make stem cell therapy a potentially viable treatment option for the serious lung complications that can result from infection with COVID-19.
Stem Cells for COVID-19
Equipped with this knowledge and recent studies out of Israel and China, we acted quickly to ramp up production of stem cells for a potential clinical trial to treat COVID-19 patients. We submitted an IND application with the FDA to launch a phase 1 study in 20 hospitalized COVID-19 patients. To support our application, we went to work to compile and publish a literature review discussing the potential benefits of stem cells to treat COVID-19.
The literature review entitled Rationale for the Clinical Use of Adipose-Derived Mesenchymal Stem Cells for COVID-19 Patients, was published in the Journal of Translational Medicine. Our medical director, Dr. Christopher Rogers, and our CEO, Dr. Robert Harman, are first and second authors of the publication, which discusses the severe symptoms that can occur in COVID-19 patients and how treatment with stem cells may help.
Infection with the novel coronavirus often progresses to severe respiratory distress and multi-organ failure, both of which may lead to death. The detrimental lung changes that can occur as a result of infection with COVID-19 may cause permanent damage. Recently, stem cell therapy was shown in clinical studies to reduce patient mortality, and in some cases, improve long-term lung function.
Personalized Stem Cells Joins the Fight
Our upcoming clinical trial will begin soon and will focus on safety of the stem cell treatment. Once complete, we hope to launch a phase 2 clinical trial to focus on efficacy. If stem cells prove successful in the treatment of COVID-19, it may become a widespread treatment option for ill patients.
When the opportunity to make a difference and potentially save lives presented itself, we sprang into action. We were immediately compelled to join the fight against COVID-19 and contribute what we could. After decades of stem cell research and experience, we believe stem cell therapy may be the key to beating this virus.