Cell Therapy Companies Making Media Claims to Treat COVID-19

Authored by the CellTrials.org Team

We present a table that compares media coverage in the western hemisphere versus clinical trial registration for cell therapy companies that propose to treat some aspect of COVID-19. According to our CellTrials.org database of COVID-19 clinical trials through 15 April 2020, out of 44 cell therapy trials launched since the start of the pandemic, almost 40% have industry sponsorship. However, most of the cell therapy trials registered to date for COVID-19, as well as their sponsors, are in China. In the table below we focus on the cell therapy companies that are receiving attention in western media.

• This table was assembled based on Google News searches on the keywords “cell therapy” (in English) through April. We do not claim this list is comprehensive, and it is a snapshot of a rapidly evolving situation.
• For those companies with media coverage, we checked our CellTrials.org database to see if they have registered a clinical trial for COVID-19. Because this field is moving rapidly, we also looked online to see if the company announced that they had received approval for a trial from the relevant government agency in their country.
• This sampling resulted in 17 companies or company partnerships.
• The type of therapeutic cells is mesenchymal stromal cells (MSC) for 12 (70%) of the companies. A few companies are employing therapies based on immune cells (NK, T-cells), and one company employs a cardiac-derived cell line.
• The MSC therapies rely on a wide variety of cell sources: bone marrow, adipose tissue, umbilical cord blood, umbilical cord tissue, placenta, and induced pluripotent cells.
• Only 6 companies have registered clinical trials so far, and 2 are pre-pandemic trials that have been extended to treat COVID-19 patients.
• We noticed that several companies started media announcements well in advance of the trial clearance by regulators.
• We are presently in a period of upheaval where some companies are bypassing the normal procedures for IND approval and registration of clinical trials. Instead, they have obtained FDA Expanded Access (“Compassionate Use”) exemptions or have applied for the FDA’s new COVID-19 Emergency Use Authorizations (EUA).
• Media reports indicate that several companies have entered clinical applications immediately upon receiving FDA approval, before registering their trial. This is reasonable and even desirable during a pandemic, but it makes it harder for us to track ongoing studies based on trial registrations.
• Several publicly traded cell therapy companies have had big jumps in their share price simply by announcing plans to treat COVID-19.
• We are starting to see media reports where companies announce preliminary study results via press release, oftentimes from the same companies that have not yet registered trials establishing the endpoint goals of their study.
• All of these disruptions in the process of entering clinical studies and reporting results of clinical studies make it harder than usual to evaluate the actual benefits of the studies.