Wednesday, April 22, 2020
US: Stem cell clinical trial for COVID-19 patients gets emergency federal approval
A team of doctors at the University of Miami (UM) Miller School of Medicine received emergency approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical trial to treat patients with severe lung inflammation as a result of COVID-19.
The doctors will use stem cells obtained from umbilical cord blood and will deliver them via intravenous (IV) infusion to 12 patients. IV infusions of stem cells are known to travel directly to the lungs, the location where damage is being caused in severe cases of COVID-19. When a patient contracts the virus, their body produces cytokines, proteins that play an important role in the immune response. Unfortunately, having too many cytokines, known as a "cytokine storm", leads to a severe immune reaction which causes damage to the lungs.
Umbilical cord stem cells are known to contain anti-inflammatory properties and the UM team hopes that the treatment can alleviate the "cytokine storm" and lung inflammation. The rationale for this approach is based off of a small study in China where seven patients received this treatment and showed improvement in lung function and symptoms. Despite these positive results, it is important to note that this trial is in very early testing and will need to demonstrate significant improvement in larger patient groups.
In an article from the Miami Herald, Dr. Camillo Ricordi, principal investigator of the trial, discusses how the results of the therapy will be observed very quickly if successful.
"This is not a study you have to follow up with in six months, because the results are immediate. In one week, you know: Is it working or not?"
In the same article from the Miami Herald, Dr. Ricordi discusses how the team of UM researchers and doctors are preparing to expand the trial to more patients if it is successful.
"We are already doing cell production anticipating this. We are planning for success, but of course we have to see how it does with our patients."
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