Prof. Ricordi, could you explain what this intervention entails in the fight against COVID-19?

At the University of Miami, we are conducting an FDA-authorized clinical trial to assess the safety and effectiveness of using umbilical cord-derived mesenchymal stem cells (MSCs) in treating severe COVID-19 cases. COVID-19 is a highly contagious virus that can lead to severe lung inflammation, making it difficult to breathe and causing oxygen levels to drop dangerously low. In severe cases, organ failure can occur, and the average time from symptom onset to death is often as short as eight days.

One of the main challenges is the excessive inflammation caused by the virus, which can mimic autoimmune diseases and lead to damage in the blood vessels and microvessels of the lungs. This can result in micro-embolisms, or small blood clots. While the body tries to counteract these clots by activating plasmin, an enzyme designed to break them down, this process inadvertently enhances the virus’s virulence, creating a dangerous chain reaction.

That’s why a combination of treatments—including anticoagulants and anti-inflammatories—is critical. Mesenchymal stem cells, in particular, act like 'smart bombs,' targeting inflammation and modulating the immune response. They’re used in treating autoimmune conditions like diabetes and lupus, and also possess antimicrobial, antibacterial, and antiviral properties, promoting tissue repair and regeneration.

Your work in the field of diabetes has brought your center to the forefront of using stem cells for COVID-19 treatment. Can you elaborate on this?

There are over 9,000 clinical trials involving stem cells worldwide, yet only 71 are focused on COVID-19. Our pilot study is the only one currently underway in Florida. The mesenchymal stem cells we are using, derived from umbilical cords, have already been tested in trials for Alzheimer’s disease and type 1 diabetes. My team has been working with these cells for 15 years, particularly in studies on type 1 diabetes, kidney transplants, and Alzheimer’s, in collaboration with the University of Miami’s neurology department.

One of the challenges with using MSCs for diseases like diabetes or kidney failure is that when injected intravenously, these cells tend to accumulate in the lungs, which act as the body's first filter. Typically, 95% of the cells get trapped there, which is problematic when you’re targeting other organs. However, since the lungs are our focus in COVID-19 treatment, this natural filter works to our advantage, and we don’t need to intervene further to redirect the cells.

Your team is collaborating with several groups worldwide, including in Italy. Can you tell us about your partnership with your home country and any future joint projects?

In Italy, I’m working with Prof. Massimo Dominici at the University of Modena and Reggio Emilia, where he’s leading a team across five centers. Their research aims to compare the effectiveness of MSCs derived from different sources, such as adipose tissue, placenta, and bone marrow. We’re also collaborating with teams in China, Israel, and the U.S., including Stanford and Harvard. Furthermore, we’ve initiated partnerships with research centers in South America and Europe.

These collaborations are essential, as they allow us to pool resources and expertise across borders to accelerate the development of effective treatments.

Given the urgency of the situation, how long will it take to determine the success of this trial?

Time is indeed critical. In keeping with our spirit of open collaboration, the trial protocol is already available online through CELLR4.org, the journal of the Cure Alliance, which is supporting our study. This is a nonprofit, academic initiative aimed at rapidly establishing a bank of MSCs, which will be distributed to hospitals free of charge and in the most efficient way possible.

Our current trial involves 24 patients, but we are scaling up cell production to supply more hospitals across the U.S. We expect to have initial results within three months, and we are optimistic that we’re moving in the right direction.