More than 11 million Americans have tested positive for COVID-19 and nearly 250,000 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 multiple recent studies cited by the Centers for Disease Control and Prevention (CDC), 14 percent of patients in the U.S. were hospitalized. Among all hospitalized patients, 26 to 32 percent were admitted to the ICU. Anywhere from 20 to 42 percent of hospitalized patients and 67 to 85 patients admitted to the ICU develop ARDS. Anywhere from 39 percent to 72 percent of patients admitted to the ICU for COVID-19, die.
While progress is being made on both vaccines and therapies, to date no approved therapy shows 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. More than 80 published review articles highlight the potential of MSCs in treating patients with COVID-19. More than 90 clinical trials are now underway exploring the potential of RMCTs for patients with COVID-19–70 of which are focused specifically on the use of MSCs.
The Alliance for Cell Therapy Research Advisory Board has been working hard—both individually, and as a group—to help patients who have contracted COVID-19. The following is a short list of what our organization is doing, to help patients in need:
- Developed, designed, and gained the commitment of multiple academic and medical institutions to collaborate on a large-scale, multi-center, randomized, placebo-controlled clinical trial to explore the use of MSCs for seriously ill patients with COVID-19 and gained approval of an IND from FDA.
- Developed and launched an outcomes database—or registry—to capture cell characterization and outcomes data from multiple studies–including clinical trials and expanded access use–involving the use of RMCTs for patients with COVID-19.
- Developed and launch a COVID-19 clinical trial tracker, highlighting all clinical trials being conducted that are exploring the use of RMCTs–including MSCs–for patients with COVID-19.
- Tracking (published and unpublished) outcomes of clinical studies exploring the use of RMCTs for patients with COVID-19.
Ongoing results of these efforts will be published in the coming weeks.