The Global Institute of Stem Cell Therapy and Research (GIOSTAR) has announced that the FDA has authorized emergency use of its stem cell therapy for hospitalized COVID-19 patients.
The San Diego–based organization has offered stem cell therapy for COVID-19-related symptoms since April 2020.
The compassionate use authorization will enable GIOSTAR to offer stem cell therapy on a case-by-case basis. A physician, GIOSTAR medical director and the FDA must jointly authorize the treatment.
The three parties will assess patients individually to determine if stem cell therapy is appropriate.
GIOSTAR reports that its therapy helped seven COVID-19 patients recover from the infection within 14 days after the patients received IV-based allogeneic mesenchymal stem cells. The research was published in Aging and Disease.
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