TUESDAY, Jan. 5, 2021 (HealthDay News) -- Stem cells derived from a baby's umbilical cord can help save the lives of the sickest COVID-19 patients, results from a small new clinical trial suggest.
Severely ill COVID patients who received two intravenous doses of stem cells three days apart were much more likely to survive and recover quickly, researchers found.
"The results are quite spectacular," said senior researcher Dr. Camillo Ricordi, director of the Diabetes Research Institute and Cell Transplant Center at the University of Miami Miller School of Medicine. "It's probably the best trial ever done for a COVID cure, because we have 100% survival in subjects less than 85 years of age versus 42% survival in the control group."
The clinical trial involved 24 COVID patients at one of two Miami-area hospitals who had developed severe acute respiratory distress syndrome, a condition in which the body's immune response to a serious infection causes the lungs to fill with fluid.
Half were randomly chosen to receive two separate IV infusions of 100 million stem cells, while the others received a placebo IV.
After one month, 91% of patients in the stem-cell-treated group had survived compared to 42% in the control group. Among patients younger than 85 years old, everyone treated with stem cells survived.
The stem cells also sped recovery time. More than half of stem-cell patients were able to leave the hospital within two weeks and more than 80% recovered by day 30, compared with less than 37% in the control group.
The therapy also proved safe, with no infusion-related serious adverse events.
Ricordi and his colleagues thought to use stem cells in COVID treatment because they had already been looking into ways the cells might help people suffering from other diseases in which the immune system causes extreme inflammation.
Previous studies have shown that stem cells are a promising therapy to blunt an overactive immune response and excessive inflammation, which damage the body's organs.
"Our results confirm the powerful anti-inflammatory, immunomodulatory effect of [umbilical stem cells]. These cells have clearly inhibited the 'cytokine storm,' a hallmark of severe COVID-19," lead researcher Giacomo Lanzoni said in a University of Miami news release. "The results are critically important not only for COVID-19 but also for other diseases characterized by aberrant and hyperinflammatory immune responses, such as autoimmune Type 1 Diabetes."
Lanzoni is an assistant research professor at the university's Diabetes Research Institute.
Research out of China and Israel had indicated that stem cells might be used to treat COVID-19 patients, but those results drew widespread skepticism because none had been randomized, Ricordi noted.
Ricordi's team has approval from the U.S. Food and Drug Administration to try stem cells as a treatment for type 1 diabetes, which is much more complicated because the infusion must take place in specific arteries that will steer the cells directly to the pancreas.
To treat COVID-19, "we could just do a simple blood transfusion, and all the cells just go automatically to the lungs," Ricordi said.
The treatment appears very promising and should be tested in larger trials, said Dr. Amesh Adalja, senior scholar with the Johns Hopkins Center for Health Security in Baltimore.
"You obviously want to see bigger studies to make sure your results are sound," said Adalja, who wasn't part of this research. "This positive study provides a path to bigger studies to understand how well this works in larger groups of patients."
Adalja expressed some skepticism that umbilical cord stem cells could be a treatment that makes its way out of large academic hospitals and into smaller community medical centers.
"It's one thing to be able to do it in an academic medical center. It's another thing to be able to do it in community hospital," Adalja said. "Is this a scalable type of intervention?"
Ricordi thinks stem cells could become a widespread treatment, given that one umbilical cord recovered from a healthy newborn can generate more than 10,000 therapeutic doses.
The team has just filed paperwork with the FDA for a larger trial involving 120 patients, Ricordi said.
"In the meantime, we will be able to offer compassionate use to hospitals in North America requesting our assistance, to ship these cells to them," he said.
Because the research is supported by a $3 million grant from North America's Building Trades Unions and additional funding from The Cure Alliance, the therapy can be offered at low cost, Ricordi added. No pharmaceutical companies are involved.
It wouldn't be the first time an academic center made a promising COVID-19 treatment widely available, Adalja noted.
"Because of the expanded access programs that were put in place by the Mayo Clinic, for example, many community hospitals that wouldn't ordinarily have access to convalescent plasma did get access to it," Adalja said. "You could envision something similar to do, but I think the next step would be larger randomized controlled trials before we would go that far."
Results from the new trial were published Jan. 5 in the journal Stem Cells Translational Medicine.
The U.S. Food and Drug Administration has more about cord blood therapies.
SOURCES: Camillo Ricordi, MD, director, Diabetes Research Institute and Cell Transplant Center, University of Miami Miller School of Medicine; Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore; University of Miami, news release, Jan. 5, 2021; Stem Cells Translational Medicine, Jan. 5, 2021