Federal Funding for Clinical Trials for COVID-19

More than 14 million Americans have tested positive for COVID-19 and nearly 280,000 Americans have died. In its most severe form, COVID-19 leads to acute respiratory distress syndrome (ARDS)—a life-threatening lung injury that allows fluid to leak into the lungs and makes it difficult for patients to breathe.

According to citations provided by the Centers for Disease Control and Prevention (CDC), anywhere from 20 to 42 percent of hospitalized patients and 67 to 85 percent of patients admitted to the ICU develop ARDS, and 39 to 72 percent of patients admitted to the ICU die. Elderly patients and minorities are at greatest risk of serious complications and death. While significant progress is being made on vaccines, and therapies are beginning to emerge, few—if any—therapies have shown significant benefit for severe cases. There is an urgent need for new modalities–that are broad-acting and safe—to help severely ill patients with COVID-19.

Early evidence shows that regenerative medicine and cell therapies (RMCTs)—and in particular, mesenchymal stromal cells (MSCs)—can play a key role in helping severely ill patients with COVID-19, given their immunomodulatory and anti-inflammatory characteristics. Early findings indicate better outcomes for seriously ill patients with COVID-19 that develop ARDs. Safety is well-documented.

While early clinical studies are promising, larger-scale, randomized, placebo-controlled clinical trials are needed urgently to confirm early results and rapidly bring safe and effective treatments to patients in need. The key barrier to conducting such trials is lack of federal funding. Of the more than $10B in supplemental funding Congress appropriated for vaccines and therapies, no funds have been directed towards promising regenerative medicine and cell therapies for patients with COVID-19. It is urgently important for Congress to direct at least some portion of funding designated for BARDA, the NIH, or other federal agencies who fund research and development of therapeutics, within the next COVID relief package or within FY 2021 appropriations legislation to advance much-needed therapies for patients in need.

Making the Case for Federal Funding for RMCTs for Patients with COVID-19

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