As the world responds to the COVID-19 pandemic, a growing number of biotech companies are pursuing clinical trials to determine the efficacy of using cell therapies to halt the virus’s deadly march. One such example is the use of mesenchymal stem cells (MSCs), multipotent stem cells found in a variety of tissues such as bone marrow and umbilical cords. But with limited data by which to judge these treatments, some practitioners wonder how cell therapies can be used to treat COVID-19.
One of the biggest drivers of COVID-19 mortality is a cytokine storm. The potentially deadly condition occurs when the body’s immune response overreacts. Typically, when an invader or infection is present, cytokine proteins are deployed in the bloodstream to marshal an attack response.
But when cytokines are released too quickly and at very high levels, immune cells can attack healthy tissues, leading to blood clots, organ damage and death. Cytokine storms have been linked to deaths in pandemics before, including the 2003 SARS epidemic and the H1N1 swine flu.
One of the leading causes of death for COVID-19 patients is acute respiratory distress syndrome (ARDS), a common manifestation of cytokine storms. ARDS is caused by the buildup of fluid in the lungs. As collaborators of a MSC therapy for COVID-19 in a Phase 2 clinical trial in Spain recently noted, finding “a treatment that attenuates the cytokine cascade could be key in rescuing the patient’s lung tissue.”
There is a growing belief that cell therapies may hold the key to unlocking this coronavirus mystery.
While many questions remain, supportive evidence for stem cell therapies is growing
Despite the promise cell therapies hold for battling the coronavirus pandemic, the precise connection between cytokine storms and COVID-19 is murky. The condition itself is more often associated with the adverse effects of cancer immunotherapy, rather than viral infections. Moreover, there is no single diagnostic test for a cytokine storm.
The first evidence of a correlation between COVID-19 and cytokine storms was reported in February in patients near the virus’s epicenter in Wuhan, China. However, researchers still don’t know why some COVID-19 patients experience an overreaction from their immune system, causing them to become much sicker than others.
What is clear is that developing therapies to tame a runaway immune response is essential to helping the worst-affected patients. Immuno-oncology drug treatments, such as tocilizumab, are one promising option. Mesenchymal stem cell therapies are another.
Dozens of clinical trials are currently underway to determine the effectiveness of using MSC treatments to slow or reverse the cytokine storm associated with COVID-19. A recent study in China found that seven COVID-19 patients who received intravenous infusions of donor MSCs improved within 48 hours. Medical centers from Miami to Rome reported similar results.
Expanding the datasets for MSC based therapies
Be The Match BioTherapies has taken steps to engage in this work. Our goal is to help further the field’s understanding of the role cell therapies can play in treating COVID-19.
For instance, we’re partnering with NantKwest to support their Phase 1b clinical trial of BM-Allo.MSC. The therapy aims to capitalize on the immunomodulatory function of MSCs to reduce inflammation associated with ARDS. The clinical trial objective is to use bone marrow-derived allogeneic MSCs to mitigate the cytopathic storm in patients requiring ventilatory support in the severe state of COVID-19.
As NantKwest Chairman and CEO Dr. Patrick Soon-Shiong puts it, “There is an immediate need for COVID-19 therapies across all stages of the disease, including for patients with ARDS… we are prepared to rapidly scale manufacturing of this much-needed therapy, potentially saving numerous patients’ lives.”
The rationale for these clinical trials — and our interest in facilitating them — is that mesenchymal stem cells, with their immunoregulatory potential, could lessen the severity of the SARS-CoV-2 virus. While this makes theoretical sense, limited trial sizes and a lack of data have yet to confirm the therapy’s full potential. More research is needed to determine how effective the treatments are for this group of patients.
Can MSC therapies help write the final chapter for COVID-19?
These are early days in developing cell therapies to treat COVID-19. Yet, prior work with MSC products in patients with ARDS has demonstrated safety and efficacy in reducing inflammatory responses. This leads many to believe there is little to lose in exploring this field further.
COVID-19 has prompted researchers to think creatively about new applications for cell therapies. There appears to be growing evidence that cell therapies will have an important role to play in creating treatments for coronavirus patients.
To discuss how Be The Match BioTherapies can support your company in the development of cell therapies for COVID-19, contact our team.