First-ever cell therapy treatment to fight covid-19 awaits FDA approval for clinical trials

The Food and Drug Administration is expected to approve a whole new type of treatment weapon to be tested amidst the global struggle against Coronavirus as the disease continues to break countries worldwide. U.S.-based company Celularity that deals in therapeutics declared that its cancer treatment, CYNK-001, is waiting for FDA’s investigational new drug status for COVID-19 to start the human trials. Once it earns the approval, it will enter a preliminary stage clinical trial to check if it can help the people suffering from the virus. Immunologists said that the treatment is viable but have also warned that it could help cure only the most severe cases of the Coronavirus. If this new strategy proves to be effective, Celularity has prepared itself to rapidly increase the production.

Celularity has already raised $311 million in venture capital funding and has attracted the support of major industries and entrepreneurs such as John Sculley, former CEO of Pepsi and Apple. Creating personalized NK cells from a patient’s blood is a really difficult and lengthy process, which is why Celularity developed CYNK-001. The company transforms placental stem cells into NK cells, which they then keep on ice, ready for transfusion into any patient, at any time. Now Celularity is hoping that its NK cells might also help patients suffering from Coronavirus. When the virus invades a body, the immune system produces a number of specialized cells that hunts down and destroys the intruders. But recognizing the virus and raising an army takes from days to a week. Meanwhile, the NK cells act as the sentinels that preventing the virus from replicating. This general capability to target any kind of diseased cells is what makes NK cells so effective against the viruses of all kinds. The company hopes that the additional NK cells will stop Covid-19 from spreading in the body, which would buy enough time for the immune system to start producing its own antibodies and permanently stop the infection in the body.

With the FDA’s approval, it will immediately start recruiting patients for a combined Phase I/Phase II clinical trial to test whether CYNK-001 is effective and safe for the patients with Coronavirus. The trial is estimated to last for 11 months, starting from recruitment to analysis. This cell therapy will be joining hundreds of other treatments that are currently undergoing FDA-approved testing for Covid-19. If it proves to be effective, Celularity will ramp up production capacities rapidly. Even if NK cells are unable to bring the Covid-19 virus to heel, the lesson gained will still be useful to the researchers.

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