By A. Rahman Ford, PNN Columnist

The COVID-19 crisis has been a catalyst for new regulatory flexibility at the U.S. Food and Drug Administration. The FDA is pushing aggressively to develop new vaccines and treatments for coronavirus, including dozens of clinical trials of stem cell therapies on critically ill patients.

Mesoblast recently dosed its first patients on ventilators in a 300-patient trial using its Remestemcel-L stem cell product to treat acute respiratory distress syndrome (ARDS). Pluristem Therapeutics is using placenta-derived stem cells in another trial, while The Cure Alliance is using umbilical-cord derived stem cells. GIOSTAR has a trial approved for its mesenchymal stem cells under the FDA’s “compassionate use” program. And Athersys has begun a large trial using stem cells derived from bone marrow on patients with moderate to severe ARDS.

A stem cell reformation of sorts is underway at the FDA due to the coronavirus pandemic. But what about the chronic pain crisis? About 50 million American lives with chronic pain, as opposed to 1.3 million confirmed cases of coronavirus in the U.S. to date.

The reformation is not only the result of COVID-19, but due to the simmering pressure of the American people, who have long demanded greater democracy and autonomy in medical treatment. The voice of the people and the virulence of the pandemic have merged into a veritable stem cell Martin Luther, the German monk who rejected the teachings of the Catholic Church during the Protestant Reformation.

Like those told to wait for the promise of stem cell therapy to materialize while being inundated with propaganda about “unproven” cellular treatments, Christians in the Midieval era were told to wait for a salvation controlled by an entrenched religious establishment -- when the salvation they sought was always right inside of them. 

One aspect of our current medical crisis is not new. Americans suffering with intractable chronic pain have endured perpetual crisis for a seeming eternity, waiting for the FDA to abandon its rigid, doctrinaire, one-size-fits-all approach to medical care in favor of more flexible, forward-thinking and tailored treatments.

The COVID-19 crisis — and Americans' consequent demand for solutions — has forced the FDA's hand. This demand compelled the FDA to reconsider its bureaucratic veneration of regulatory relics that denied the revolutionary novelty of stem cells.

The FDA deserves some credit for finally acknowledging the need for exploration and innovation in its clinical trial procedures. But now the agency must recognize that chronic pain - like COVID-19 - is a national medical crisis that necessitates a similar creative solution.

Stem cell regulatory innovation must not end with coronavirus. In fact, it must continue and accelerate. Yes, the current progress is heartening. However, more must be done. And needs to be done immediately. The chronic pain crisis demands it.

The FDA's current push for stem cell innovation must proceed beyond the therapeutic necessity of coronavirus. The agency needs to reform its restrictions on the use of our own stem cells for treating arthritis, neuropathy, degenerative disc disease and other chronic pain conditions.

This reform must no longer be the subject of directionless academic debate or an issue for consideration by medical "ethicists" and self-proclaimed protectors of the common good. The time for debate and delay has ended. The time for decisive action has arrived.  

At the core of the matter are the cries of millions of Americans in a critical crisis of pain that existed well before the face masks, latex gloves, hand-washing, social distancing and trillions of dollars in federal appropriations that COVID-19 has spawned.

To the FDA and Commissioner Stephen Hahn, your effort in pursuing stem cell therapy for COVID-19 treatment has not gone unnoticed. Now it is time to relax FDA regulations on the use of our own stem cells. Devolve regulatory authority to the states and their oversight, and let physicians and patients decide when stem cell therapies are appropriate.

This is the next logical step in the FDA's reformation. It is a necessary step. It is the right step.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The opinions expressed in this column are those of the author alone and do not inherently reflect the views, opinions and/or positions of Pain News Network.