Anticipated Impact of Stem Cell and Other Cellular Medicine Clinical Trials for COVID-19

Abstract

Aim: There is a critical need for safe and effective treatments for COVID-19. One possible type of treatment is cellular medicine such as stem cell therapy, but its potential is unclear. Here, our aim was to assess the potential impact of the many cellular medicine trials for COVID-19. Materials & methods: We collected and analyzed data for defined criteria from trial registries. Results: Our data suggest that relatively few of these COVID-19 trials will produce high-level evidence, but that on average they may be somewhat more rigorous than typical cell therapy trials unrelated to COVID-19. Conclusion: Most COVID-19 cellular medicine trials have relatively low potential for rapid, concrete impact. We discuss the findings in the context of the cellular medicine field overall.

Ethical issues and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic

“…Multiple studies have reviewed clinical trial registries to describe and evaluate the evolving landscape of cell-based clinical research targeting various symptoms of COVID-19 ( Kim and Knoepfler, 2021 ; Liao et al., 2020 ). Based on searches conducted in August 2020, one study found 70 clinical trials examining various stem cell-based interventions—predominantly MSCs—and another 9 exploring the use of NK cells to target COVID-19 symptoms ( Kim and Knoepfler, 2021 ).…”

“…Multiple studies have reviewed clinical trial registries to describe and evaluate the evolving landscape of cell-based clinical research targeting various symptoms of COVID-19 ( Kim and Knoepfler, 2021 ; Liao et al., 2020 ). Based on searches conducted in August 2020, one study found 70 clinical trials examining various stem cell-based interventions—predominantly MSCs—and another 9 exploring the use of NK cells to target COVID-19 symptoms ( Kim and Knoepfler, 2021 ). Most trials were relatively small (mean: 51.8 participants) and only 22% (18/79) were randomized, double blinded, and controlled, leading the authors of this analysis to conclude that ongoing clinical trials that utilized cell-based interventions for COVID-19 symptoms were likely to have “relatively small collective clinical impact” ( Kim and Knoepfler, 2021 ).…”

“…Based on searches conducted in August 2020, one study found 70 clinical trials examining various stem cell-based interventions—predominantly MSCs—and another 9 exploring the use of NK cells to target COVID-19 symptoms ( Kim and Knoepfler, 2021 ). Most trials were relatively small (mean: 51.8 participants) and only 22% (18/79) were randomized, double blinded, and controlled, leading the authors of this analysis to conclude that ongoing clinical trials that utilized cell-based interventions for COVID-19 symptoms were likely to have “relatively small collective clinical impact” ( Kim and Knoepfler, 2021 ). These results prompt concerns that many studies testing cell-based products to treat or prevent COVID-19 exhibit troubling signs of pandemic research exceptionalism, much like the broader effort to develop COVID-19 therapeutics, with one FDA report estimating that only “6% of clinical trials are yielding results the agency deems actionable” ( Baumann, 2020 ).…”