Celularitys subsidiary, LifebankUSA, maintains a repository of placental and cord blood, containing stem cells for potential therapeutic use. (LifebankUSA / Robert Hariri via Twitter)

Seattles Infectious Disease Research Institute and a New Jersey company called Celularity have been cleared by the Food and Drug Administration to start trials of an experimental cell-based therapy for COVID-19.

The immunotherapy treatment makes use of natural killer cells, or NK cells, which play a key role in the bodys natural defense against viral infections. Celularitys NK cell product, known as CYNK-001, is derived from placental stem cells for treating viral diseases as well as some types of blood cancers and tumors.

CYNK-001 has been safely given to patients in early trials for treating leukemia and multiple myeloma. Now the FDA has given investigational new drug clearance for its use to be extended to COVID-19, the disease caused by the coronavirus outbreak.

To date, efforts to treat COVID-19 cases have been primarily focused on antiviral medications, Corey Casper, who is CEO of the Infectious Disease Research Institute as well as a clinical professor of global health at the University of Washington, explained in a news release.While these are important, patients with serious disease may not respond completely to antiviral medications because they are experiencing damage already inflicted on the bodys vital organs.

About 80 to 100 patients diagnosed with pneumonia due to a COVID-19 infection will be enrolled at medical centers in the U.S., potentially including sites in Washington state. Participants in the study will be provided with infusions of CYNK-001.

The hypothesis is that administering NK cells to patients with moderate to severe COVID-19 will allow the immune cells find the sites of active viral infection, kill the virus, and induce a robust immune response that will help heal the damage and control the infection, Casper said. Beyond its promise as a critically needed treatment for COVID-19, the biology of NK cells indicates a possibility that this immunotherapy could be used as an off-the-shelf treatment for future pandemic infections.

Initial results are expected about 30 to 60 days after the first patients receive the cells. If the results are encouraging, a more rigorous clinical trial would follow.

Last weekend, Rudy Giuliani, President Donald Trumps personal attorney, touted the treatment on Twitter, saying that this therapy has real potential. This week, the FDA gave its clearance for the preliminary tests on an expedited basis.

In a statement issued today, Celularitys chairman and CEO, Robert Hariri, thanked the FDAs Center for Biologics Evaluation and Research for their tireless effort to guide us through the process of clearing the drugs use for COVID-19.

The New York Times quoted Paul Knopfler, a stem cell researcher at the University of California at Davis, as saying that Celularitys approach carried some risk. Its conceivable that the NK cells could exacerbate problems by massive killing of the patients respiratory cells, he told the Times.

The FDA has cleared testing of several other therapies for COVID-19, including use of the drugs hydroxychloroquine and remdesivir as well as blood plasma from recovered patients. In addition, the first U.S. clinical trial of a COVID-19 vaccine is underway at Seattles Kaiser Permanente Washington Research Institute.

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Celularity and Infectious Disease Research Institute will try out COVID-19 cell therapy - GeekWire