A simple search for keywords leaves the impression that there are hundreds of exosome clinical trials. But once we apply the requirements that the product meets the ISEV definition and has a clearly defined purification step, there are less than one hundred exosome clinical trials worldwide to date.
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We have published the first look at how the cytokine response to COVID-19 overlaps with the leading cytokines seen in Graft versus Host Disease (GvHD). Cytokine markers have proven predictive for disease severity and outcome during inflammatory disorders. Hence, the fact that MSC have proven effective at treating GvHD bodes well for MSC therapies of COVID-19.
CellTrials.org has launched the world's first database of exosome clinical trials and their publications. Although we use the popularized term exosomes, in fact we include all clinical trials that employ any form of Extracellular Vesicles (EV) and/or Conditioned Medium (CdM).
COVID-19 is a moving target for clinical trials: as the outbreaks move, either from one country to another or within a country, clinical trial managers must partner with different hospitals to recruit patients. Only those trial sponsors that are strong enough to form relationships with multiple hospitals will be able to accrue large numbers of patients for their trials.
CellTrials.org suggests that pulmonary fibrosis in COVID-19 survivors is a new opportunity for MSC therapy, and may be the most feasible and effective application of MSC to Coronavirus.
Despite COVID-19, nearly 30% more advanced cell therapy trials were registered during 2020 Q1 than in the previous year. The fraction of the non-COVID-19 trials that are recruiting is about the same as last year.
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. During this time of upheaval, some companies are bypassing the normal trial registration process and entering clinical applications based on Compassionate Use Exemptions or Emergency Use Authorizations.
CellTrials.org reveals that none of the previous clinical trials of MSC for ARDS were able to demonstrate efficacy. Companies rushing to treat COVID-19 patients with MSC are hyping their potential.
We forecast that CAR-immunotherapy sourced from universal donors is a growth field. The use of donor cells eliminates the patient apheresis step and the associated time delay to wait for autologous cells to be converted to CAR cells.
The number of CAR immunotherapy trials have risen 25-fold over the past decade. Clinical trials with some type of T-cells accounted for 70% of all immunotherapy clinical trials in 2019.