FDA OKs 1st Stem Cell Human Trial for COVID-19

April 3, 2020 — A human clinical trial of an experimental stem cell therapy for coronavirus patients has been approved by the U.S. Food and Drug Administration.

The stem cell treatment is derived from human placentas and is being developed by New Jersey biotech company Celularity. The early-stage trial will include up to 86 coronavirus patients with symptoms who will receive infusions of the stem cell therapy to assess the its safety and whether it prevents the patients from developing more severe illness, The New York Times.

The stem cells from the placenta used in this treatment are “natural killer” cells that guard a developing fetus or newborn from viruses in the mother. Celularity has been testing this treatment approach in cancer patients.

Initial results from the early trial are expected 30 to 60 days after the first patients receive their dose, Dr. Robert Hariri, Celularity’s founder and chief executive, told The Times.

If the early trial is successful, the company would conduct a placebo-controlled study that would evaluate the drug’s efficacy against the disease, Hariri said.

Hariri is a longtime friend of White House advisor Rudy Giuliani, who has touted the therapy in tweets and on a podcast, the Times reported.

And at least one expert warned the therapy could pose safety risks. Patients with coronavirus can develop severe reactions in which their immune systems go overboard in attacking cells in their lungs, causing harmful inflammation, Paul Knoepfler, a stem cell researcher at the University of California, Davis, told The Times.

One risk with the natural killer cells is that they could worsen existing respiratory problems “by massive killing of the patients’ respiratory cells,” he warned.

Other cell therapies tested in China are designed to weaken the immune response, The Times reported.