Recently, Personalized Stem Cells (PSC) was asked by the White House Task Force to apply to the FDA for expedited review of their application for using stem cells to treat patients with COVID-19. Stem cell therapy is a distinct approach that treats lung inflammation caused by COVID-19 to critically ill patients in the hospital.
PSC teamed up with Calidi Biotherapeutics, an oncology company, to gain momentum in the production of this therapy. Calidi Biotherapeutics donated pre-tested, viable stem cell lines to PSC , something that would otherwise take weeks to obtain.
Physicians in both China and Israel have published notable positive results from treating patients with COVID-19 with stem cells. In fact, Israel announced the results of compassionate use of stem cells in seven COVID-19 patients, reporting 100% recovery. PSC is using this experience by their Chinese collaborators in Wuhan and Beijing to create the best treatment protocol possible for their clinical trials in the United States.
On March 30th, PSC submitted their emergency assistance application to the FDA and its formal IND submission this week. PSC already has FDA-inspected stem cell manufacturing facilities that are producing stem cell doses for clinical trials. The use of stem cell research for COVID-19 patients is also going to be considered for compassionate use.
Dr. Bob Harman, CEO of PSC, states, “Stem cell doses can be released for clinical trial use in May, depending on FDA clinical trial approval.” The first trial will be conducted in San Diego, California in a controlled capacity to hospitalized patients. Compassionate use could allow a significant number of patients to be treated.
PSC is an “essential services company” and their momentum is not slowing. In fact, they are following a meticulous protection program to ensure the safety of all of their employees. It is their passion that brings stem cell therapy to patients in need. Every possible resource is being utilized to support physicians on the front-line who are saving patients’ lives.