President Trump Should Consider Stem Cell Therapy for His COVID-19

By A. Rahman Ford, PNN Columnist

President Trump remains hospitalized at Walter Reed Medical Center after being diagnosed with COVID-19 last week, along with First Lady Melania Trump. The president suffered from fever, congestion and fatigue, and received supplemental oxygen therapy before being admitted Friday.

Details about his current condition and treatment are scant, but Trump has reportedly received an experimental antibody drug and started a course of the antiviral drug remdesivir. In a video posted on Twitter Saturday night, the president said he was “starting to feel good” but the next few days would be “the real test.”

With few effective treatments available for coronavirus, the president and his doctors should seriously consider stem cell therapy, which is being investigated in dozens of clinical trials as a treatment for coronavirus. Other experimental therapies like hydroxychloroquine, remdesivir and blood plasma are not effective for all patients.

Coincidentally, President Trump has long been an advocate for stem cell therapy. In his 2017 State of the Union Address, he acknowledged the medical plight of a woman who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis. Trump said seriously ill patients “should have access to experimental treatments” without traveling overseas and urged Congress to pass the Right to Try Act so that Americans can get help “right here at home.”

Stem cell therapy may be the safest and most effective treatment for the most life-threatening symptom of COVID-19, acute respiratory distress syndrome (ARDS), an inflammatory “cytokine storm” in the lungs that makes breathing difficult. The conventional intervention for ARDS – mechanical ventilation – is invasive, overused and can increase the likelihood of bacterial infections.

Stem cells have intrinsic immune supporting properties that can ease the deleterious effects of ARDS. They could also potentially heal any tissue damage that ARDS may cause to lungs.

Research Supports Stem Cells for COVID-19

Even if President Trump’s symptoms are mild, the prophylactic use of stem cells to prevent disease spread is worthy of investigation. Celltex Therapeutics is currently conducting a Phase 2 multi-center, double-blind, randomized, placebo-controlled trial to evaluate the prophylactic effectiveness of autologous, adipose-derived mesenchymal stromal cells (MSC).

A recent review of the scientific literature on MSC therapy concluded that “Cellular based therapies hold great promise for the treatment of COVID-19.” Another study echoed that finding, saying “MSCs possess both regenerative and immunomodulatory properties, the latter of which can be harnessed to reduce the severity and longevity of ARDS in patients under intensive care due to SARS-CoV-2 infection.”

Researchers in China have called MSC therapy a “promising strategy” for COVID-19, but cautioned that “there is not enough clinical evidence to prove the effectiveness of MSCs in the treatment of ARDS.”  They called for large-scale, multicenter trials to further explore the safety and efficacy of MSCs.  

Other recent studies have concluded that stem cells “may possibly be one of the most ideal therapeutics” for COVID-19 and “might be considered for compassionate use in critically ill patients.”

FDA Approved Trials

Early in the pandemic, the FDA approved several clinical trials of stem cells for treating COVID-19. These trials are now at various stages of progress, ranging from investigational new drug (IND) applications, to active recruitment of patients, to late stage clinical studies. Trial sponsors include: VetStem, M.D. Anderson Cancer Center, Personalized Stem Cells, Hope Biosciences, Thomas Advanced Medical, Restem, University of Miami, Mesoblast, NantKwest, Baylor College of Medicine, Athersys, Masonic Cancer Center, Celltex and Pluristem Therapeutics.

More recently, Baylx had its IND application approved for umbilical cord-derived MSC cells and Stemedica Cell Technologies’ IND application for intravenous allogeneic MSCs. The FDA has even cleared Pluristem Therapeutics’ existing stem cell product for treating ARDS, allowing the company to treat up to 100 severely affected COVID-19 patients outside of a clinical trial.

There are also several ongoing international trials of stem cells, including studies in Jordan, United Arab Emirates, Pakistan, Mexico and Brazil.

President Trump and First Lady Melania owe it to themselves – and to us – to consider every possible treatment for COVID-19. The administration should also ensure that all Americans have access to stem cell therapy for COVID-19, by expediting clinical trials, expanding compassionate use, and granting emergency use authorization for advanced stem cell products, as was done for convalescent plasma. Ultimately, the president and FDA should relax restrictions on the use of our own stem cells for indications beyond COVID-19.

We all wish the President and First Lady a full and speedy recovery.

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. 

Compounded Pain Creams Ineffective for Chronic Pain

By Pat Anson, PNN Editor

Compounded topical pain creams work no better than placebo creams and should not be used to treat chronic pain, according to a new study published in the Annals of Internal Medicine.

Researchers at the Walter Reed National Military Medical Center enrolled nearly 400 people with chronic neuropathic, joint or muscle pain in the study. Some received pain creams specially compounded to treat their type of pain, while others received a placebo cream.

The compounded pain creams included a blend of FDA-approved drugs such as ketamine, lidocaine and gabapentin, or a combination of muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs). The creams were applied to the affected areas three times a day.

One month after treatment began, researchers found no significant differences in the pain scores of patients who used the real pain creams and those who used the placebo ones.

“We found that specially formulated compounded pain creams provided little benefit in our study participants,” said lead author Steven Cohen, MD, Director of Pain Research at Walter Reed.

“Overall, the response rate was lower than that afforded by stand-alone creams shown to be effective for specific conditions, such as NSAIDs and lidocaine. Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain.”

While some of the medications in pain creams may be effective when taken orally or intravenously, Cohen and his colleagues say they are not absorbed through the skin in sufficient doses to be effective. Another drawback is their cost, which can reach thousands of dollars.

A recent report from the Office of Inspector General for the Department of Health and Human Services found that over 500 pharmacies that billed Medicare for compounded topical creams had suspiciously high costs. One pharmacy in Florida billed Medicare for $1.8 million in pain creams in 2016.

Medicare spending for compounded creams, gels and ointments has skyrocketed, rising from $13 million in 2010 to $323 million in 2016. Price hikes and a growing number of prescriptions for pain creams drove the increase, the Inspector General’s report found.

Medicare paid an average of $751 per tube of compounded lidocaine and $1,506 for a tube of the NSAID diclofenac. Non-compounded tubes of those same drugs averaged $445 and $128, respectively.

Last year the FDA said it would inspect compounding facilities to assess whether drugs that are essentially copies of FDA-approved medications could be sold commercially at less cost.