Some critically ill COVID-19 patients at Cedars-Sinai Medical Center showed significant improvement after receiving an experimental treatment of lab-grown human heart tissue, researchers reported Tuesday.
Four of six coronavirus patients who were intravenously given cardiosphere-derived cells, or CDCs, got well enough to be discharged from the hospital, according to a case series published Tuesday by Cedars-Sinai and Capricor Therapeutics in the scientific journal “Basic Research in Cardiology.”
Dr. Eduardo Marban, executive director of the Smidt Heart Institute at Cedars-Sinai, reported that within four days of the infusions, four patients suffering from respiratory failure were able to breathe without support. In less than three weeks, those four were discharged from the hospital.
None of the patients showed adverse effects from the infusions, he said, and none died during the study period. Two of the six patients remained hospitalized in intensive care, as of April 28.
By comparison, six people died among a group of 34 comparable COVID-19 patients who were treated in Cedars-Sinai’s intensive care unit around the same time but did not receive cell therapy, hospital officials said. The patients in the case series were treated under emergency use provisions, which allow therapies not yet approved by the Food and Drug Administration.
The case series is believed to be the first peer-reviewed report on using the cell therapy in critically ill COVID-19 patients. Investigators said patient outcomes, while encouraging, are not sufficient to prove that the therapeutic is safe and effective for treating COVID-19 without a clinical trial and control group.
Dr. Raj Makkar, the principal author of the published case series, said a future clinical trial is being planned.
“The only way to establish the efficacy of our therapy is with a randomized clinical trial,” he said. “That is because some coronavirus patients get better on their own with standard treatments.”
The doctors said the therapeutic, known as CAP-1002, was previously used in clinical research focused on the treatment of heart failure, and it contains cells grown in the laboratory from heart tissue.
Now, researchers believe there are wider applications for CDCs.
“Previous studies provided strong evidence that CDCs have intense benefits for the immune system and inflammation in a number of diseases. They accomplish this by secreting exosomes — nanoscale vesicles with a variety of active contents that travel widely throughout the body,” Marban said.
For those critically ill with COVID-19, Marban said the treatment’s anti-inflammatory effect could be a critical boost since the body’s overreaction to the COVID-19 infection often delivers the fatal blow, especially in later stages of the disease.
“Friendly fire is what’s killing many coronavirus patients,” Marban said. “The immune system unleashes a so-called cytokine storm into the blood — overwhelming the body with infection-fighting proteins that can trigger multiple-organ failure and death.”
If CDCs counteract immune overreaction in coronavirus patients, the doctors said the cells potentially could help prevent or treat two other life-threatening conditions that can develop with COVID-19 patients: acute respiratory distress and inflammation of the heart muscle, known as myocarditis.
Doctors at Cedars-Sinai conducted the emergency use treatment in collaboration with the biotechnology company Capricor Therapeutics in Los Angeles, which manufactured CAP-1002. Funding for the study came from the Smidt Family Foundation.