More than 19 million Americans have tested positive for COVID-19 and more than 330,000 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.
- 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.
The Role of Regenerative Medicine and Cell Therapies in Battling 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 100 published review articles highlight the promise or potential of MSCs in treating patients with COVID-19; and
- At least 100 clinical trials exploring the use of RMCTs for patients with COVID-19—79 of which are focused specifically on the use of MSCs—are listed on www.clinicaltrials.gov.
What We’re Doing to Tackle COVID-19
Alliance for Cell Therapy Now and members of its Research Advisory Board have been working hard to help COVID-19 patients. The following is a short list of what our organization is doing—with the guidance and leadership of our Advisory Board—to help patients in need:
- Clinical Trials and Results Tracking. Developed and launched a COVID-19 clinical trial tracker, highlighting clinical trials being conducted that are exploring the use of RMCTs—including MSCs—for patients with COVID-19, and their results.
- FDA-Approved, Multi-Center Clinical Trial. 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 which received IND approval from the FDA in August 2020.
- Outcomes Database. Developed and launched an outcomes database—or registry—to capture outcomes data from multiple studies—including clinical trials and use under expanded access protocols—involving the use of RMCTs for patients with COVID-19.