The Case for Federal Investment in Cell-BasedTherapies for...

The Case for Federal Investment in Cell-BasedTherapies for Patients with COVID-19
March 24, 2021

Early evidence shows that cell-based therapies, including mesenchymal stromal cells (MSCs), can play a key role in helpingseverely ill patients with COVID-19, given their immunomodulatory and anti-inflammatory characteristics.

A systematic review and meta-analysis of clinical trials led by researchers at the Mayo Clinic and including researchers fromthe Duke University School of Medicine, Emory University, Case Western Reserve University, and the University of Miami MillerSchool of Medicine, showed a positive trend toward improved pulmonary function, reduced lung inflammation, and reducedmortality for patients with ARDS who were treated with MSCs.
Several review articles published over the last year show similarresults.As summarized in Figure 1, at least 140 review articles have been published in peer-reviewed publications since March 2020that offer insights on the potential or promise of cell-based therapies for patients with COVID-19. The vast majority (96percent) describe the role of MSCs in treating COVID-19 patients. Review articles also describe the role of T-Reg cells, inducedpluripotent stem cells (iPSCs), natural killer (NK) cells, and progenitor cells in addressing COVID-19.

Researchers involved in 27 clinical studies involving the use of cell-based therapies for seriously ill patients with COVID-19 havepublished their results, 25 of which were published or are to be published in peer-reviewed journals.Across all 25 studies with results published in peer-reviewed journals, mortality rates averaged 8 percent, which is less than theaverage mortality rate for severely ill patients with COVID-19 in the ICU, which range from 39 percent to 72 percent.Nine of the 25 published studies were based on expanded access use of cell-based therapies for COVID patients. Only 5 of the25 published findings were based on randomized, controlled trials, and the other 11 studies did not include randomization.Therefore the conclusions that can be drawn from published findings to date are limited.

While results from early phase clinical trials and meta-analyses and systematic reviewsshow promise, the large-scale, randomized, placebo-controlled clinical trials that areneeded to confirm early results and ultimately bring safe and effective treatments toseverely ill COVID-19 patients will not occur without federal funding and support.

The Biden Administration has recognized the lack of reliable and accessible treatmentsfor COVID-19 and the need for investment in the development and manufacturing oftherapies both within the January 21, 2021 Executive Order and the American RescuePlan, which formed the basis for the COVID-19 relief package passed by Congress andsigned into law by the President in early March 2021.

Congress has also authorized nearly $40 billion in funding for vaccines, therapeutics,and other medical supplies within three COVID-19 relief packages—two of which werepassed and signed into law in 2020 and one of which was signed into law earlier thisyear.However to date, little or no federal funding provided through COVID-19 relieflegislation has been used to support clinical trials exploring the use of cell-basedtherapies for patients with COVID-19, despite the more than 100 clinical studiesthat have been initiated and the 140 published articles that describe the promise orpotential of these therapies for this deadly disease.

https://allianceforcelltherapynow.org/wp-content/uploads/2021/03/ACTN-Case-for-Federal-Funding-of-Cell-Based-Therapies-for-COVID-19_Final-for-Release.pdf

https://www.regmedfoundation.org/2021/03/26/cell-based-therapies-show-promise-for-seriously-ill-patients-with-covid-19/