Researchers at the University of Miami Miller School of Medicine have received approval from the United States Food and Drug Administration to start a small clinical trial using stem cells against COVID-19.
The trial will evaluate the use of umbilical cord-derived mesenchymal stem cells to address the symptoms of life-threatening lung inflammation suffered by people with the severe form of the disease caused by Coronavirus.
Dr. Camillo Ricordi, director of the Diabetes Research Institute and Cell Transplant Centre at the school and the principal investigator on the trial, said the cells derived from one umbilical cord, which are typically discarded after a woman gives birth, could generate enough stem cells to treat over 10,000 patients.
Stem cells have the capability of becoming specialized cells that sometimes repair damage, and the type taken from umbilical cords — known as mesenchymal stem cells — are adaptable to a number of uses.
“There is no time to waste,” said Dr. Ricordi. “Patients who die from COVID-19 have a median time of just 10 days between first symptoms and death. In severe cases oxygen levels in the bloodstream drop, and the inability to breathe pushes patients toward their end very quickly; any intervention that might prevent that trajectory would be highly desirable.”
Ricordi is particularly optimistic about that potential for the type of life-threatening lung condition that can accompany COVID-19, because IV infusions of the stem cells are known to naturally flow to the lungs.
Beyond that, Ricordi said the mesenchymal stem cells are known to have anti-inflammatory qualities that help calm so-called “cytokine storms,” when a patient’s immune system is kicked into overdrive and does more damage than the virus itself.
“It’s practically injecting an army of cells that can fight some of the most severe complications of the virus infection,” Ricordi told the Miami Herald.
The 24-patient trial will begin this week in Miami, with half of the patients receiving the stem cell therapy and the other half serving as the control group. Those patients will not receive stem cell infusions but will still be administered advanced medical treatment, Ricordi said.
As an established diabetes researcher, Ricordi has already developed notable treatments with stem cell therapy, including one trial that allowed patients with Type 1 diabetes to avoid insulin after receiving stem cell transplants.
After seeing small but promising studies in China and Israel, Ricordi said he is “very optimistic” because he works with those researchers.
The China study looked at 10 patients in Beijing from January 23 to February 16, observing the effects of the treatment for two weeks after stem cell injections in seven of those patients. For all seven, the researchers found that lung function and other symptoms significantly improved two to four days after the treatment.
Ashok K. Shetty, associate director of the Institute for Regenerative Medicine at Texas A&M University College of Medicine and co-editor of the the Aging and Disease medical journal, said in an editorial that the Chinese study showed promise.
“This study demonstrated that intravenous infusion of MSCs is a safe and effective approach for treating patients with COVID-19 pneumonia, including elderly patients displaying severe pneumonia,” Shetty said.
Ricordi said UM already has the manufacturing capability in place to treat the patients in the trial, and that could be expanded quickly. He added that if the trial is expanded, he believes the team would have the ability to treat all of the COVID-19 patients at UM and its partner Jackson Health System, Miami’s public hospital.
The doctors should be able to tell if that expansion is coming soon.
“This is not a study you have to follow up with in six months, because the results are immediate,” Ricordi said. “In one week, you know: Is it working or not?”
To that end, Ricordi said UM researchers and doctors are already preparing to expand the trial to more patients.
“We are already doing cell production anticipating this,” he said. “We are planning for success, but of course we have to see how it does with our patients.”