Washington, DC (September 13, 2021) – A new report released by Alliance for Cell Therapy Now, an independent, non-profit organization guided by leaders representing academic and medical institutions, industry innovators, and patients, makes the case for increased federal investment in cell-based therapies for patients with COVID-19.
As the nation continues to face the unprecedented and growing challenges of the coronavirus pandemic, the number of Americans that are contracting COVID-19, becoming hospitalized, and in many cases—dying—is high and continuing to grow. More than 40 million Americans have tested positive for COVID-19 and more than 650,000 Americans have died.
There is an urgent need for new treatments to help reduce the severity of illness, the number of hospitalizations, and death related to COVID-19. Evidence from numerous clinical studies shows that cell-based therapies can play a key role in helping severely ill patients with COVID-19, given their immunomodulatory and anti-inflammatory characteristics.
At least 130 clinical studies have been launched that explore the use of cell-based therapies for patients with COVID-19, 52 (or 40%) of which are being conducted in the United States. At least 175 peer-reviewed articles have been published that describe the promise or potential of these therapies for treating COVID-19 patients.
While results from clinical studies are promising, the vast majority of such studies (89%) are either Phase 1 or Phase 2 studies. Large-scale, randomized, placebo-controlled clinical trials are needed to confirm early results and help bring safe and effective treatments to patients in need.
The largest barrier to conducting clinical research related to cell-based therapies is the high cost of conducting these studies. The financial barriers associated with clinical trials are particularly problematic for academic and research institutions and small biotechnology companies, who are responsible for nearly all of the clinical trials being conducted for COVID-19 both in the U.S. and abroad. Federal funding is needed to help bring promising cell-based therapies to patients with COVID-19 and other serious and life-threatening conditions.
The Administration recognizes the lack of reliable and accessible treatments for COVID-19 and the need for investment in the development and manufacturing of therapies. Both the January 21, 2021 Executive Order and the American Rescue Plan (which formed the basis for the COVID-19 relief package passed by Congress and signed into law in March 2021) contained policies to accelerate the development of novel therapies to treat COVID-19. In early September 2021, the Administration released a COVID-19 action plan that also contained actions that support the development and administration of treatments to reduce hospitalizations and save lives.
Several Democratic and Republican members of the House of Representatives and the Senate have called for greater investment in the development and manufacturing of cell-based therapies to support patients in need.
As Congress considers appropriations for the coming year, as well as a reconciliation package this Fall, it should designate funds for research on cell-based therapies to augment limited options currently available, to help seriously ill patients with COVID-19, as well as patients with other serious and life-threatening conditions.
About Alliance for Cell Therapy Now
Alliance for Cell Therapy Now (ACT Now) is an independent, non-profit organization guided by leaders representing academic and medical institutions, industry innovators, and patients, that is working to advance safe and effective regenerative medicine and cell therapies for patients in need. See www.allianceforcelltherapynow.org