A New Jersey biotech startup says it has received clearance from the Food and Drug Administration to begin testing a potential treatment for people who have been infected with the coronavirus.
The company, Celularity, announced Thursday that the FDA has given it permission to begin Phase I and II clinical trials on adults who have tested positive for Covid-19. Trials will begin immediately at medical facilities across the country.
The company's proprietary therapy uses stem cells derived from human placentas. The treatment is administered intravenously.
"With our initial clinical study, we will gain an understanding of the impact [this therapy] can have on patients recently diagnosed with Covid-19," said co-founder Dr. Robert Harari in a statement. "We are hopeful to contribute to flattening the Covid-19 curve."
Celularity believes this is the first immunotherapy to receive FDA approval to treat adults infected with Covid-19. The FDA has approved other treatments, such as the use of the anti-malarial drugs hydroxychloroquine and chloroquine, for use against Covid-19. A team of researchers in Portland is currently awaiting FDA approval to begin testing a potential vaccine.
Warren, New Jersey-based Celularity was co-founded in 2016 by serial entrepreneur Peter Diamandis and Dr. Robert Harari with the stated goal of extending the human lifespan. It emerged from stealth mode in 2018 with $250 million in funding from parent company Celgene, biotech firm Sorrento Therapeutics, and others. In addition to Covid-19, the company is attempting to develop stem cell treatments for cancer and other illnesses.