COVID-19 continues to wreak havoc on the world. The United States is experiencing a massive resurgence in cases, likely due to a lack of preventative measures and reopening states from lockdown too soon. Other nations, such as France, are also experiencing the repercussions of reopening their economies too early, while nations like Brazil, which have never taken the virus seriously, are seeing incredibly high infection rates.
Of course, COVID-19 does not affect everyone in the same way. In fact, one new study identified six different "types" of COVID-19, each with its own range of symptoms and conditions. Some patients may be completely asymptomatic. Others will experience mild to moderate symptoms. However, a significant percentage of cases will see severe symptoms, require hospitalization, and potentially require intubation with a ventilator.
What Are Severe COVID-19 Symptoms?
The symptoms present in patients struggling with COVID-19 can range dramatically from a basic dry cough to pneumonia and neurological damage. According to a study published in The New England Journal of Medicine,
"The most common initial symptoms of coronavirus disease are fever, cough, fatigue, anorexia, myalgias, and diarrhea. Severe illness usually begins approximately 1 week after the onset of symptoms. Dyspnea is the most common symptom of severe disease and is often accompanied by hypoxemia.
A striking feature of Covid-19 is the rapid progression of respiratory failure soon after the onset of dyspnea and hypoxemia. Patients with severe Covid-19 commonly meet the criteria for the acute respiratory distress syndrome (ARDS), which is defined as the acute onset of bilateral infiltrates, severe hypoxemia, and lung edema that is not fully explained by cardiac failure or fluid overload. The majority of patients with severe Covid-19 have lymphopenia, and some have disorders of the central or peripheral nervous system.
Severe Covid-19 may also lead to acute cardiac, kidney, and liver injury, in addition to cardiac arrhythmias, rhabdomyolysis, coagulopathy, and shock. These organ failures may be associated with a cytokine release syndrome characterized by high fevers, thrombocytopenia, hyperferritinemia, and elevation of other inflammatory markers."
Treatment for severe COVID-19 includes a broad range of tactics, from ventilation to support care and more. However, these strategies are not effective in many cases. Stem cell therapy may be a viable alternative or supplemental treatment option.
Umbilical Cord Stem Cell Therapy
Announced in late May, the FDA has approved a phase 1/2a study designed to evaluate the performance and effectiveness of mesenchymal stem cells sourced from umbilical bord blood and tissue (allogeneic stem cells) to treat patients with severe cases of COVID-19.
According to a press release originally published on MPR,
"The multicenter, randomized, blinded, placebo-controlled SUCCESS (Systemic Umbilical Cord Cells to Ease Severe Syndrome) study will assess the efficacy and safety of umbilical cord mesenchymal stem cells provided by RESTEM, a cell-based therapeutics company, in hospitalized patients with severe COVID-19. RESTEM’s cells are grown from umbilical cord tissue through a proprietary process that rapidly replicates millions of doses.
The SUCCESS study will identify COVID-19 patients with acute respiratory distress syndrome (ARDS) who would best benefit from the therapy. Patient enrollment is expected to begin this week from Baptist Health South Florida and Sanford Health."
Why Stem Cell Therapy?
With the wide range of therapeutic treatment options available, why are researchers focusing on stem cell therapy to help treat severe cases? It seems that the treatment has shown significant promise already. In late April 2020, Baptist Health South Florida and RESTEM, a biotech company, jointly announced the successful treatment of three patients suffering from severe COVID-19 symptoms using stem cell therapy and MSCs sourced from umbilical cord blood. It is on those results, at least in part, that the FDA approved further study of this treatment modality.
What We Know About the Study
While details of the upcoming study are scarce, there is some information to be gleaned, including the following:
- It will involve 60 patients.
- The study will be conducted by RESTEM, in conjunction with Baptist Health South Florida.
- It will be the first study of its kind.
- Enrollment will take place at the Miami Cancer Institute in Florida, as well as Sanford Health in South Dakota.
It’s worth noting that a second, similar study began near the end of May 2020. This trail involves 100 patients and the use of PRP and cord blood in improving COVID-19 symptoms. This study is estimated to wrap up in September 2020.
Why Stem Cells?
Stem cells have been researched as a viable treatment for an incredible range of diseases, many of which involve severe inflammation and/or immune system response. According to a study entitled Expanded Umbilical Cord Mesenchymal Stem Cells as a Therapeutic Strategy in Managing Critically Ill COVID-19 Patients,
"expanded umbilical cord mesenchymal stem cells or (UC-MSCs) may have a role and are being studied. The cure of COVID-19 is essentially dependent on the patients' own immune system. When the immune system is over-activated in an attempt to kill the virus, this can lead to the production of a large number of inflammatory factors, resulting in a severe cytokine storm.
The cytokine storm may induce organ damage followed by the edema, dysfunction of air exchange, acute respiratory distress syndrome (ARDS), acute cardiac injury, and secondary infection, which may lead to death. Thus, at this point, the avoidance of the cytokine storm may be the key to the treatment of HCOV-19 infected patients. In China, where there was limited availability of effective modalities to manage COVID-19 several patients were treated with expanded UC-MSCs. Additionally, the Italian College of Anesthesia, Analgesia, Resuscitation and Intensive Care have reported guidelines to treat coronavirus patients with stem cells in the hope of decreasing the number of patients going to the ICU, and, also relatively quickly getting them out of ICU."
Healing and Hope
Umbilical cord stem cell therapy holds a great deal of promise. However, patients must understand that no such therapy has been approved by the FDA, and all treatments are experimental only. In addition, while this treatment may reduce symptoms or even halt the disease, it’s imperative to work with a physician well-versed in using allogeneic stem cells.