SAN DIEGO — A San Diego biotech company is seeking emergency FDA approval for an experimental trial of stem cell therapy for coronavirus patients.
Personalized Stem Cells Incorporated (PSC) in Poway said the therapy could reduce the most serious complications of the infection in the lungs.
PSC CEO, Dr. Bob Harman, said the company is asking to test the treatment on a group of 20 hospitalized COVID-19 patients in the first phase of a clinical trial.
"Stem cell doses will be ready for clinical trial use in May, depending on FDA approval," Harman said.
Harman said they've already scaled up production of stem cells in anticipation of FDA approval.
PSC Medical Director, Dr. Christopher Rogers, stated, "I believe this is the most promising therapy being explored by medical scientists at this time and stem cells may potentially reduce the most serious complications of coronavirus infection."
The FDA has a new program called the Coronavirus Therapeutic Accelerator Program (CTAP) to help speed up the launch of FDA clinical trials for hopeful COVID-19 therapies.
PSC was asked by the White House Coronavirus Task Force to apply to the FDA CTAP program for expedited review of their application.
PSC hopes to rapidly complete the CoronaStem 1 study and then proceed into a larger Phase 2 clinical trial and potentially into FDA compassionate use programs to reach more patients.
More information can be found on the PSC website.