New Drug Could Improve Effectiveness of Stem Cell Therapy

By Pat Anson, PNN Editor

Scientists have developed an experimental drug that can lure stem cells to damaged tissues and help them heal -- a discovery being touted as a major advancement in the field of regenerative medicine.

The findings, recently published in the Proceedings of the National Academy of Sciences (PNAS), could improve the effectiveness of stem cell therapy in treating spinal cord injuries, stroke, amyotrophic lateral sclerosis (ALS), Parkinson’s disease and other neurodegenerative disorders. It could also expand the use of stem cells to treat conditions such as heart disease and arthritis. 

“The ability to instruct a stem cell where to go in the body or to a particular region of a given organ is the Holy Grail for regenerative medicine,” said lead author Evan Snyder, MD, director of the Center for Stem Cells & Regenerative Medicine at Sanford Burnham Prebys Medical Discovery Institute in La Jolla, CA. “Now, for the first time ever, we can direct a stem cell to a desired location and focus its therapeutic impact.”

Over a decade ago, Snyder and his colleagues discovered that stem cells are drawn to inflammation -- a biological “fire alarm” that signals tissue damage has occurred. However, using inflammation as a therapeutic lure for stem cells wasn’t advisable because they could further inflame diseased or damaged organs, joints and other tissue.

To get around that problem, scientists modified CXCL12 -- an inflammatory molecule that Snyder’s team discovered could guide stem cells to sites in need of repair— to create a drug called SDV1a. The new drug works by enhancing stem cell binding, while minimizing inflammatory signals.

“Since inflammation can be dangerous, we modified CXCL12 by stripping away the risky bit and maximizing the good bit,” Snyder explained. “Now we have a drug that draws stem cells to a region of pathology, but without creating or worsening unwanted inflammation.”

To demonstrate its effectiveness, Snyder’s team injected SDV1a and human neural stem cells into the brains of mice with a neurodegenerative disease called Sandhoff disease. The experiment showed that the drug helped stem cells migrate and perform healing functions, which included extending lifespan, delaying symptom onset, and preserving motor function for much longer than mice that didn’t receive the drug. Importantly, the stem cells also did not worsen the inflammation.

Researchers are now testing SDV1a’s ability to improve stem cell therapy in a mouse model of ALS, also known as Lou Gehrig’s disease, which is caused by a progressive loss of motor neurons in the brain. Previous studies conducted by Snyder’s team found that broadening the spread of neural stem cells helps more motor neurons survive — so they are hopeful that SDV1a will improve the effectiveness of neuroprotective stem cells and help slow the onset and progression of ALS. 

“We are optimistic that this drug’s mechanism of action may potentially benefit a variety of neurodegenerative disorders, as well as non-neurological conditions such as heart disease, arthritis and even brain cancer,” says Snyder. “Interestingly, because CXCL12 and its receptor are implicated in the cytokine storm that characterizes severe COVID-19, some of our insights into how to selectively inhibit inflammation without suppressing other normal processes may be useful in that arena as well.”

Snyder’s research is supported by the National Institutes of Health, U.S. Department of Defense, National Tay-Sachs & Allied Disease Foundation, Children’s Neurobiological Solutions Foundation, and the California Institute for Regenerative Medicine (CIRM).

“Thanks to decades of investment in stem cell science, we are making tremendous progress in our understanding of how these cells work and how they can be harnessed to help reverse injury or disease,” says Maria Millan, MD, president and CEO of CIRM. “This drug could help speed the development of stem cell treatments for spinal cord injury, Alzheimer’s, heart disease and many other conditions for which no effective treatment exists.”

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. 

Stem Cell Osteoarthritis Studies Advance

By Pat Anson, PNN Editor

A Canadian doctor is recruiting patients for a "first of its kind" stem cell research project for osteoarthritis. The Phase II study could further advance the use of regenerative medicine in treating osteoarthritis, a joint disease for which treatment options are currently limited to pain medication, steroid injections or joint replacement surgery.

"This is a potential game changer in the management of osteoarthritis," says lead investigator Dr. Grant Pagdin.  "Evidence is building that regenerative procedures using the combination of biologic materials we are investigating here have the potential to reduce joint pain and improve function.” 

Pagdin is recruiting 255 Canadians with osteoarthritis from 19 to 79 years of age. The purpose of the study is to demonstrate the effectiveness of combining platelet-rich plasma (PRP) derived from a patient’s own blood with stem cells derived from their body fat (adipose tissue) or bone marrow.  

Participants will be randomly assigned to one of three groups that will receive injections of PRP and adipose stem cells, PRP and bone marrow stem cells, or PRP with both types of stem cells. Three injections of the biologic material will be made into an arthritic joint. Participants will then be followed for up to 24 months to see which treatment worked better

Meanwhile, a California stem cell company has announced that enrollment has officially ended for a similar study of stem cells. Thirty-eight patients with knee osteoarthritis have been recruited by Personalized Stem Cells (PSC) for a Phase I trial to have adipose stem cells injected into one knee. The study was originally set to have up to 125 patients, but was scaled back due to COVID-19 concerns.

"While stem cells have previously been used successfully in the treatment of osteoarthritis, our goal is to produce high quality data and ultimately receive FDA approval so that arthritic patients have access to PSC's quality tested stem cell treatments," Dr. Robert Harman, PSC’s CEO, said in a statement.

PSC hopes to submit results from the study to the FDA by the end of 2020, after which a Phase II blinded, placebo-controlled study will be launched.

In addition to the osteoarthritis knee study, PSC recently received FDA approval to launch a small clinical trial for the treatment of COVID-19 patients with stem cells. The company also plans to pursue FDA approval of stem cells for the treatment of back pain and traumatic brain injuries, as well as arthritis affecting other joints.

A small Phase II clinical trial recently found a single injection of adipose stem cells can significantly reduce osteoarthritis knee pain for up to a year with no serious side effects, according to findings published in the American Journal of Sports Medicine.

More than 27 million Americans live with osteoarthritis, a progressive condition caused by the breakdown of joint cartilage. Osteoarthritis causes pain, physical disability, lower quality of life, and is associated with early death and cardiovascular problems.

FDA's Stem Cell Reformation Must Go Beyond COVID-19

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.

 

FDA Approves Stem Cell Trials for Coronavirus

By A. Rahman Ford, PNN Columnist

As the U.S. comes to terms with the severe and often deadly consequences of the COVID-19 outbreak, novel medical interventions are being sought to stem the tide of casualties.

President Trump has touted the use of hydroxychloroquine to treat coronavirus, while the Food and Drug Administration has approved clinical trials for the anti-viral drug remdesivir and blood plasma from those who have recovered from COVID-19.

The FDA has also quietly approved clinical trials of stem cell therapy. The use of stem cells is intriguing because of their established immunomodulatory properties and their ability to repair injured tissue, such as the lungs that are ravaged by more severe cases of coronavirus.

A key driver of death among coronavirus cases is Acute Respiratory Distress Syndrome (ARDS), which is characterized by an explosive acute inflammatory response in the lungs, also known as a “cytokine storm.”

Currently, the main therapeutic intervention for ARDS is mechanical ventilation. However, ventilators are invasive, in short supply and they increase the risk of bacterial infections.

Several stem cell companies are following the lead of Chinese scientists, who used injections of mesenchymal stem cells (MSCs) derived from umbilical cord blood to successfully treat patients with coronarvirus infections.  

A small study recently published in the journal Aging and Disease confirmed the safety and effectiveness of MSCs in treating 7 patients in a Beijing hospital with COVID-19 pneumonia. The study’s authors found that MSC injections inhibit the overactivation of the immune system, regulate inflammatory response, promote tissue repair and improve lung function.

The FDA recently approved an investigational new drug application from Australia-based Mesoblast for intravenous infusion of its MSC product called remestemcel-L.

“The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial,” Mesoblast Chief Medical Officer Dr. Fred Grossma said in a statement.

Remestemcel-L has been under development by Mesoblast for several years. It is believed to counteract inflammatory processes by inhibiting production of pro-inflammatory cytokines by white blood cells, while promoting the production of anti-inflammatory cells. The safety and therapeutic effects of remestemcel-L infusions have been evaluated in over 1,100 patients in various clinical trials.

Texas-based Hope Biosciences has also received FDA approval for a Phase II clinical trial to evaluate the safety and efficacy of MSCs in providing immune support against COVID-19. The company uses a patient’s own stem cells – referred to as autologous cells – to treat trial participants who are at a higher risk of developing severe COVID-19 symptoms.

“Most people who have been severely affected by COVID-19 had preexisting conditions. We are pre-treating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus,” said Donna Chang, President and CEO of Hope Biosciences.

Celltex Therapeutics, another Texas-based company, has applied to the FDA for emergency expanded access to its autologous MSCs to treat COVID-19. Celltex uses proprietary technology that isolates, multiplies and stores MSC’s derived from fat tissue for use in regenerative therapy for a number of conditions, including vascular, autoimmune and degenerative diseases.

New Jersey-based Celularity has received FDA approval to begin a trial of stem cells derived from human placentas – what the company calls “Natural Killer” cells. Celularity’s product – CYNK-001 – has already been used safely in patients with leukemia and multiple myeloma.

Natural killer cells play a key role in the body’s natural defense against viral infections. Former New York Mayor Rudy Guliani recently discussed the trial with Celularity founder and CEO Robert Hariri on his YouTube channel.

The FDA’s current effort to speed these therapies to Americans who need them is laudable. However, its effort could be enhanced exponentially by loosening its restrictions on autologous stem cells more generally. When the health of so many Americans is imperiled and the avenues for treatment are so few, waiting is not an acceptable option.

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.

Non-Profit Offers Free Stem Cell Therapy to Veterans

By A. Rahman Ford, PNN Columnist

No group is more worthy of the revolutionary benefits of stem cell therapy than America’s military veterans. While the U.S. Department of Veterans Affairs (VA) thinks “the field is in its infancy and much more research is needed” before stem cells are offered as treatment, brave practitioners are stepping forward to help veterans NOW.

Dr. Joseph Kanan and his staff at the Tullahoma Chiropractic Center are providing free stem cell therapy for veterans who suffer from chronic pain. Kanan – in partnership with Veterans in Pain – recently performed his first pro bono procedure on a veteran named Ryan, who has severe hip pain. Stem cell injections into Ryan’s hip, which are not covered by insurance, normally would have cost $6,500. Ryan got them for free.

“I think veterans do a lot for our country and there are very few doctors that are performing medical procedures like this,” Kanan told The Tullahoma News. “We were very glad to be able to do this for him.”

Kanan says his Tennessee clinic performs stem cell therapy for veterans twice a month and has had good results so far. One patient was able to avoid a knee replacement and reported consistent improvement one year after the procedure. Patients can expect to experience 10 percent improvement every month for 10 months.

Veterans in Pain is a non-profit that connects military veterans with civilian physicians who provide free regenerative medicine treatments for chronic pain. VIP has provided $250,000 worth of services since 2019.

(Update: Veterans in Pain no longer directly links individual veterans with stem cell providers. The organization’s focus has shifted to advocacy — specifically changes in legislation to make stem cell therapy more accessible to veterans.)

VIP founder and president Micaela Bensko is herself a stem cell therapy recipient. She spent years in a wheelchair after an accident in her driveway left her with severe spine damage that led to arachnoiditis, a chronic inflammation of spinal nerves. A friend suggested stem cell therapy, which inspired Bensko to establish VIP as a resource for veterans. 

Veterans in Pain connects each veteran with a volunteer physician in their area. If one cannot be located, the cost of transportation and accommodations are covered for treatments, as they were for Ryan. Veterans associated with VIP visit schools, organizations and corporations sharing their story of recovery. Most of VIP’s funding is provided by small individual donations, grants and grassroots fundraising. 

According to the National Institutes of Health, nearly two-thirds of veterans report having chronic pain, with about 9% having severe pain. Chronic pain among veterans is closely associated with mental health conditions such as depression, anxiety, poor sleep and substance abuse disorders. Many veterans suffer from more than one condition.

Because of red tape and a shortage of pain management specialists at the VA, many veterans suffering from chronic pain are left devoid of proper diagnosis and treatment, causing many to self-medicate or search for answers on their own.  Chronic pain can lead to substance abuse, a common and growing trend among veterans. A 2017 study found that 30% of military suicides were preceded by alcohol or drug abuse.

The dire plight of military veterans suffering from chronic pain is yet another compelling reason for the FDA to loosen its regulation of stem cell therapy. Our heroes are counting on it.

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.

Chinese Scientists Using Stem Cells to Treat Coronavirus Patients

By Pat Anson, PNN Editor

As scientists around the world scramble to develop vaccines, therapeutic treatments and diagnostic tests for the coronavirus, Chinese doctors are having some initial success using stem cells to treat — and possibly cure — coronavirus infections.

Dr. Dongcheng Wu, who runs a stem cell lab in Wuhan, China – the epicenter of the COVID-19 outbreak – says he has successfully treated nine critically ill patients hospitalized with coronavirus pneumonia.

The patients had acute lung inflammation and serious breathing problems when they volunteered for experimental injections of Mesenchymal stem cells (MSCs) derived from human umbilical cords. All nine reportedly recovered within days.

“This treatment could potentially save thousands upon thousands of lives, so naturally we are very happy with these results,” Wu told the Daily Mail. 'Yes, it is a cure, but it is still very early in the process and we still have work to do.”

Wu is the chief science officer for Blue Horizon International (BHI), a New York-based foundation that supports research in stem cell therapy and cellular regenerative medicine.

BHI is currently recruiting 48 coronavirus patients in China for a placebo-controlled study of MSC injections.

In studies on mice, researchers found that MSC cells migrated to the lungs, where they significantly reduced inflammation and repaired damaged tissue.

BLUE HORIZON INTERNATIONAL

“So we thought what the heck, let's give it a shot. We gave nine patients, who were in hospital with severe, acute pulmonary dysfunction, we gave them core blood stem cells via IV and 100 percent of them got better, so of course we were astounded,” Dr. Brian Mehling, co-founder of BHI, told the Daily Mail.

The BHI study is not the first to use stem cells to treat coronavirus patients. According to the South China Morning Post, over a dozen clinical trials are underway in China using stem cells as a treatment for COVID-19.

Last month, a 65-year old woman infected with coronavirus was fighting for her life in an intensive care unit when she was injected with stem cells. Within days, her vital signs returned to normal, she began walking again, and tested negative for the COVID-19 virus.

Like Dr. Wu’s patients, the woman received MSC cells derived from the umbilical cords of newborn babies.

“Although only one case was shown here, it could be very important and inspire similar clinical practices in treating critically ill COVID-19 patients,” researchers reported in ChinaXiv, a Chinese website that publishes studies that have not yet been peer-reviewed.

Stem Cells ‘Could Cure’ Coronavirus Patients

Another new study, published in the journal Aging and Disease, found that MSCs given to seven coronavirus patients in Beijing “could cure or significantly improve” their symptoms.

“The pulmonary function and symptoms of these seven patients were significantly improved in 2 days after MSC transplantation. Among them, two common and one severe patient were recovered and discharged in 10 days after treatment,” researchers reported. “Thus, the intravenous transplantation of MSCs was safe and effective for treatment in patients with COVID-19 pneumonia, especially for the patients in critically severe condition.”

A Beijing doctor, who asked not to be identified, said there was growing discussion in the Chinese medical community about stem cells as a treatment for coronavirus.

“The stem cell industry may have some vested interest to promote their technology in this crisis, but if it really works, it should be made available to more patients,” she told the Morning Post.

Chinese stem cell researchers appear to be far ahead of their counterparts in the United States, where stem cell therapy remains controversial and there are more regulatory hurdles. Virtually all of the coronavirus stem cell studies listed in a U.S. database of clinical trials are being conducted in China.

Texas-based Celltex Therapeutics recently asked the Food and Drug Administration for permission to conduct a clinical study in the U.S. on the safety and efficacy of MSCs as a treatment for coronavirus.

David vs. Goliath: California’s Stem Cell Program Demonizes Small Clinics

By A. Rahman Ford, PNN Columnist

In a recent article published in Stem Cells Translational Medicine, officials with the California Institute for Regenerative Medicine (CIRM) call for nationally uniform standards for stem cell products to facilitate the ”responsible delivery of regenerative medicine.”

Some of their recommendations are reasonable. However, CIRM’s insistence upon uniformity and their demonization of small stem cell clinics in a contrived narrative is sophomoric, disingenuous and counterproductive.

CIRM was created in 2004 when California voters passed Proposition 71, the California Stem Cell Research and Cures Initiative. Supporters of Prop 71 lamented how the federal government had failed to provide adequate funding for stem cell research, so the state needed to step in and provide $295 million in bonds to advance stem cell treatments to patients with unmet medical needs.

CIRM is currently at a financial crossroads. To date, CIRM has funded over 1,000 research, training and community engagement projects. However, with its initial funding almost gone, it is now seeking an additional $5.5 billion through a ballot initiative. While CIRM has been strong in research, no CIRM-funded trial has won FDA approval. According to Nature, CIRM has funded 55 clinical trials but only one therapy is likely to hit the market any time soon.

Indeed, a 2018 San Francisco Chronicle investigation found that CIRM’s achievements “fall far short of what Prop. 71’s promoters promised.” Furthermore, “the bulk of CIRM grants have gone to basic research, training programs and building new laboratories, not to clinical trials testing the kind of potential cures and therapies the billions of dollars were supposed to deliver.”

Thus, while it’s noteworthy that CIRM-funded scientists have published over 330 scholarly articles in some of the top academic journals, practical results remain negligible to non-existent.

Promises Laid Upon False Premises

California’s scientific and physical infrastructure has benefited greatly from CIRM, but sick and disabled Californians have not. The fact that CIRM’s accomplishments have been so minimal makes their claims about acting in “the best interest of the patient” all the more curious.

Lead author Geoffrey Lomax, PhD, a Program Manager at CIRM, and colleagues argue that clinics offering stem cell treatments are in need of increased regulatory oversight. Toward that end, they recommend a new policy framework with technical, organizational and ethical benchmarks aimed at developing a standard of care for the stem cell industry. It pledges adherence to the FDA clinical trial process and chastises clinics for flaunting long-established rules for drug approval.

“There are documented examples of unproven stem cell interventions causing harm to patients. In the majority of examples, the intervention deviates from the norms of responsible medical practice. Numerous authoritative bodies have raised concerns over the potential for medical and financial harm to result from these practices,” Lomax wrote.

Generally speaking, some of their recommendations make sense. For example, they recommend that doctors, nurses and technicians providing stem cell treatments possess specialized training and expertise. They also recommend that providers educate and evaluate patents throughout the treatment process. Finally, the authors support the creation of a stem cell registry to facilitate the reporting of adverse events resulting from stem cell treatments.

However, these common-sense recommendations are overlaid by a rigid, forced adherence to an anachronistic model of medical treatment. This model is the FDA clinical trial process, which treats a patient’s own stem cells as “drugs.” That is unfortunate, because stem cell therapies are revolutionary, paradigm-shifting and defy old conceptions about drugs and medicine.

Perhaps the most glaring sin is CIRM’s demonization of small clinics offering stem cell treatments. These clinics are producing the real-world results that CIRM has not. This “us vs. them” approach occludes truth and impedes progress to the detriment of those most in need. It is unnecessary to diminish the value of others’ efforts to bolster or justify one’s own. Cooperation, not contrived competition, is in the best interest of patients.

Furthermore, forced uniformity in stem cell policy standards may not be the answer. Let us not forget that it was the state of California in 1996 that led the way on medical marijuana, amidst a cacophony of marijuana opponents who decried the potential for a “wild west” of rogue marijuana dispensaries that would prey upon desperate patients.

Now, years later, we see that none of those calamities materialized. For CIRM to now use the same argument and same invective toward stem cell clinics seems disingenuous and hypocritical.

Lomax fails to see that from the patient perspective the narrative is not “heroic” CIRM vs. the “villain” clinics, but more of a story of the “Goliath” CIRM vs. the “David” clinics. We all know how that story turned out.

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.

FDA Scoffs at ‘Third Way’ Forward in Stem Cell Therapy

By A. Rahman Ford, PNN Columnist

In a commentary recently published in the journal Stem Cells and Development, Jeffrey Gimble, MD, and his co-authors make a measured critique of the FDA’s cautious regulation of autologous stem cells, including cells derived from adipose tissue, a person’s own body fat.  

Gimble, who is the co-founder of Obatala Sciences, a Louisiana stem cell company, shares the FDA’s concerns about the rapidly evolving field of regenerative medicine and proposes a “third way” forward that protects patients, while loosening federal regulation of the industry.

Gimble and his co-authors take aim at “rogue” predatory clinics offering stem cells in a “wild west” medical landscape. In their view, a “combustible mix of unmet needs, an ambiguous regulatory pathway, untested therapies, and clinics rapidly rushing in to fill a void” is at the root of several cases of patients being injured by stem cell procedures.

Sadly, the authors are parroting fictionalized, unsubstantiated stem cell propaganda to support their position.

Gimble and his colleagues contend that autologous cell therapies should be exempt from the FDA’s conventional clinical trial process, which was intended for pharmaceuticals, not a person’s own stem cells.

In their view, primary authority for policing stem cell practitioners should be at the state level, with accreditation agencies, state medical boards and specialty societies. In essence, they want the FDA to relinquish oversight of stem cell therapy.

Gimble and his co-authors recommend the FDA re-evaluate how it categorizes tissues as “structural” or “cellular” to recognize the different safety profiles of stem cells products.  They also think the FDA should work with accreditation agencies like AABB and FACT to develop meaningful accreditation standards, along with a national registry for stem cell therapies.

An Imperfect Way Forward?

This measured “third way” seeks to carve a compromise between the FDA’s regulationist faction and “wild west” stem cell providers -- a new ideological center that synthesizes the aspirations of two opposing parties in an effort to achieve a compromise.

It must be stated that there are serious questions as to whether the authors’ proposed polarity is in fact an artifice created for the specific purpose of legitimizing their “third way.” Upon serious inspection, the authors’ stated “dangers” of stem cell clinics may actually be a disingenuous straw man created for their own business interests.

To promote their own agenda and to gain favor with the FDA, Gimble and his co-authors seem to have thrown stem cell clinicians like Dr. Mark Berman under the proverbial bus. Berman, who is a defendant in a FDA lawsuit over his use of autologous cells, recently won a victory in federal court. The judge found that the FDA may not have regulatory authority over Berman’s procedures and that a trial needs to be held to resolve the issue.

FDA Scoffs at Compromise

Nevertheless, the impetus behind the authors’ recommendations is to move forward with bringing stem cells to patients faster and in a safer manner. Regrettably, the FDA does anything but take the authors seriously. In a lengthy response to the Gimble article, Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, merely reiterates the agency’s firmly-established regulationist position.

After commending the authors for their “desire to accelerate the scientific investigation and development of stem cell therapies,” Marks demonstrates the FDA’s backward-looking posture by stating the agency’s regulation of stem cells “is distinct from the practice of medicine” and should be left alone.

“This is an existing paradigm that has been in place for decades,” Marks wrote. “Autologous cellular therapies do hold tremendous promise, but they will only find their way into routine clinical practice to bring benefit to all patients if they are held to the same standards to demonstrate safety and efficacy as other unproven medical products.”

Marks attempts to bolster his argument by citing patient safety, the dearth of research on adipose-derived stem cells and the unethical “bad actor” clinics that exploit desperate patients. However, the spirit of his position reveals a resistance to any sort of change whatsoever.

Marks and the FDA are living in the past. They consider your cells to be unproven medical products. Apparently, they have yet to realize that the stem cell poles have already shifted.

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. 

Mayo Clinic Research Shows Stem Cells May Treat Paralysis

By A. Rahman Ford, PNN Columnist

In a case report recently published in Mayo Clinic Proceedings, a 53-year-old California man paralyzed from the neck down in a surfing accident experienced dramatic improvement after an injection of his own stem cells.  

Chris Barr can walk again and has shown other improvements in his motor and sensory functions. His case is significant, because currently there is no FDA-approved therapy that can reverse the devastating life-changing effects of paralysis from spinal cord injuries.

Barr’s inspiring story can be seen in this video produced by the Mayo Clinic:

Barr was one of 10 paralyzed adults enrolled in a Phase I clinical trial that looked at the safety, side effects and ideal dose of stem cells. Early findings show that patient response varied. Mayo researchers call Barr a “superresponder” because his treatment was so successful.

"In this case report, the first patient was a superresponder, but there are other patients in the trial who are moderate responders and nonresponders," says first author Mohamad Bydon, MD, a Mayo Clinic neurologic surgeon. "One of our objectives in this study and future studies is to better delineate who will be a responder and why patients respond differently to stem cell injections.”

According to the National Spinal Cord Injury Statistical Center, about 288,000 Americans currently suffer from a spinal cord injury (SCI). Over 17,000 Americans suffer SCI’s each year, costing the health care system over $40 billion annually.  The estimated lifetime cost for each patient can range from the hundreds of thousands into the millions of dollars, and their life expectancy rates fall far below those without SCI.

Chronic pain is a serious problem that can result from SCI, affecting about two-thirds of patients, with one out of three reporting their pain as severe. With the inherent limitations of medical interventions such as surgery, medication and physical rehabilitation, new strategies are needed to improve functional outcomes and quality of life.

Although stem cells have  successfully been used to treat inflammatory conditions that affect the spinal cord, such as arachnoiditis, published reports on their safety and effectiveness in treating SCI‘s are scant.

Animal studies have demonstrated effectiveness in treating SCI with embryonic stem cells and human neural stem cells. Mesenchymal stem cells (MSC’s) derived from bone marrow have also been successfully used to treat SCI in rats, as have human umbilical cord-derived stem cells. And adipose stem cells derived from fat have been used to improve functional recovery in dogs with SCI.

Barr’s Impressive Results

After being paralyzed in the surfing accident, Chris Barr’s condition initially improved after a posterior cervical decompression and fusion. However, that improvement plateaued after six months. Barr had complete loss of motor function below the site of his injury, including bowel and bladder sensation.

Barr enrolled in the Mayo study nine months after his injury. His stem cells were collected by taking a small amount of fat from his abdomen. Over eight weeks, the cells were grown in the laboratory to 100 million cells. Those MSC cells were then injected into Barr’s lower back, 11 months after his injury.

The results from the therapy were impressive and long lasting. Eighteen months after stem cell injection, Barr’s total upper extremity motor score increased from 35 to 44. There was also considerable improvement in his total lower extremity motor scores, from 36 to 49. Improvement in sensory scores was likewise remarkable.

Barr reported significant improvement in his quality of life, as well as mental and physical health. He was able to walk further, faster and for a longer period of time. His range of motion for shoulder flexion and shoulder abduction also improved.

“Given the multidimensional complexity of SCI, cell-based therapies have offered substantial promise as a therapeutic strategy because of the multifactorial roles that stem cells can potentially provide,” Bydon wrote.

Bydon and his colleagues caution in generalizing from Barr’s remarkable results, although there is cause for optimism. The Mayo team plans to continue analyzing patient responses, and further results will be published on the other nine trial participants.

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. 

This column is not intended as medical advice and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

WWE Superstars Use Stem Cells to Smackdown Pain

By A. Rahman Ford, PNN Columnist

As a child, I was a big fan of professional wrestling. While I don’t follow it as religiously as I used to, I have noticed a rather interesting trend. Several former wrestlers are opting for stem cell therapy to heal painful injuries. And some travel to foreign countries to get stem cell treatments they can’t get in the U.S.

Many people consider professional wrestling a fake sport, but to wrestlers their injuries are very real. Bleacher Report’s Ryan Dilbert has reported on the toll wrestling can take on the body.  He recalled how Diamond Dallas Page was “power bombed” by Kevin Nash, rupturing two vertebrae in his back.  Page was injured so badly he couldn’t finish the match.

"I was in excruciating pain," Page said. "I was on my back, and I crawled to the corner. I didn't go back in the ring."

Three-time World Wrestling Entertainment (WWE) women’s champion Beth Phoenix once finished a match with a broken jaw.

"Fans may see us once or twice a year," said Phoenix, who is now retired. "They don't realize that we go on these grueling tours. We're on the road 300 days a year. There's no recovery time. It's a test of your physical and mental endurance."

A 2014 study in the journal PLOS One found that professional wrestlers had “an alarmingly high premature mortality rate.” Wrestlers were 4.5 times more likely to die than the general population. The authors cited chronic pain and drug addiction as likely culprits.

“It is reasonable to assume chronic musculoskeletal injuries resulting in abuse of pain-relieving prescription drugs play a role in the premature drug-related deaths and possibly suicide among some wrestlers. It is also plausible that the painful injuries are self-treated with high doses of non-steroidal anti-inflammatory drugs (NSAIDs),” they said.

Consider what happened to these three professional wrestlers:

Former Olympic gold medalist Kurt Angle became addicted to painkillers after he fractured his back. At his worst, Angle was taking 65 extra-strength Vicodin a day.

Former WWE Superstar Lance Cade became addicted to hydrocodone after suffering a shoulder injury. He died six months after completing a drug rehab program, with hydrocodone found in his system at the autopsy.

Former WWE Superstar Ashley Massaro committed suicide in May of this year. The 39-year old suffered from migraines and bouts of depression, which she maintained were a result of wrestling injuries.

“WWE used narcotics as a tool to allow me and other wrestlers to perform through our injuries. If we took enough pills the pain went away (temporarily) and we were able to wrestle. Obviously, this worsened our injuries and required us to take more pain medication the next time,” Massaro said in an affidavit for a recently-dismissed federal lawsuit.

‘Substantial Benefit’ From Stem Cells

Some professional wrestlers are turning to stem cell therapy as an alternative to pain relievers. WWE Superstar Ronda Rousey received stem cells to treat an ACL injury to her knee.  In a documentary, Rousey said the damage to her knee was so severe that for several years she could not even comfortably step backwards. Rousey says stem cell therapy “really helped a lot.”

IMPACT Wrestling World Champion Brian Cage recently traveled to Colombia for stem cell treatment for a back injury.

“The injury was awful. One of the most painful moments of my career. I literally thought my career might be over,” Page told the Lords of Pain. “I was doing everything under the sun to try and recover from that, including going to Columbia and getting the stem cells, and I do believe it did have a substantial benefit to it.”

Wrestlers Melissa Santos, Rey Mysterio, Ryback and Angle also made the trip to Colombia for stem cell treatments. Ryback says he is now 100% healed. And Angle recently told fans on Facebook that he’s doing better.

“My shoulders feel great. My neck and back are struggling a bit but I’m optimistic about them getting better just like my shoulders. It usually takes 3-6 months to feel improvement. It’s been 2 months,” Angle said.

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. 

This column is not intended as medical advice and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Rare Autoimmune Disease Goes Into Remission After Stem Cell Therapy

By A. Rahman Ford, PNN Columnist

New research at Northwestern University and the Mayo Clinic confirms that we can heal ourselves with our own stem cells. A small study published in the journal Neurology found that treating a person with stem cells derived from their own blood or bone marrow can reverse a rare autoimmune disease called neuromyelitis optica (NMO).

Also known as Devic Disease, NMO is a chronic neurological disorder that causes inflammation in the optic nerve and spinal cord. Common symptoms are eye pain that can rapidly lead to blindness, and pain in the spine, legs or arms that can lead to paralysis. Bladder and bowel control may also be affected.

Neuromyelitis optica is often misdiagnosed as multiple sclerosis (MS). The normal course of treatment is high-dose corticosteroids and immunosuppressants.

In the study, 13 patients with NMO were first given drugs to suppress their immune system, followed by an infusion of hematopoietic stem cells (HSCT).

The results were significant and durable. After 57 months, most patients were in remission and were off all immunosuppressive drugs.

A biological marker in the blood that correlates with NMO disease activity also disappeared.

“There is marked difference between a transplant and the drug,” said lead author Dr. Richard Burt, a professor of medicine and chief of immunotherapy and autoimmune disease at Northwestern University Feinberg School of Medicine. “The transplant improved patients’ neurological disability and quality of life. They got better, and the disease maker disappeared for up to five years after transplant.”

Two of the patients relapsed after the HSCT infusion and had to go back on drug therapy.

According to Northwestern Now, Dr. Burt is a pioneer in the field of using autologous stem cells to treat autoimmune disease. Previous research by Burt has shown that HSCT can reverse relapsing-remitting multiple sclerosis, systemic sclerosis and chronic inflammatory demyelinating polyneuropathy.

When interviewed  by The Daily Northwestern about the implications of Burt’s work, Feinberg Associate Neurology Professor Dr. Roumen Balabanov predicted that chronic autoimmune diseases would be treated through “a single, radical approach” that would allow patients to live normal lives without being dependent on medications to control their symptoms.

“The point of this treatment being radical is that the patients will actually have normal lives,” Balabanov said. “They don’t have to take those lifelong medications.”

Those lifelong drugs can cost up to $500,000 per year. Conversely, the HSCT transplant costs about $100,000.

Dr. Burt is currently on sabbatical to teach his HSCT protocol at stem cell clinics around the country and to write a book. Actress Selma Blair recently had her multiple sclerosis treated by Burt’s clinic. She has been very public about her experience on social media and in interviews.

Recently the Scottish Health Technologies Group recommended HSCT be approved in Scotland to treat relapsing-remitting multiple sclerosis.

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 information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

A Very Uncharitable Pew Stem Cell Policy Report

By A. Rahman Ford, PNN Columnist

The Pew Charitable Trust – an institution whose stated mission is to “encourage democratic participation” in accordance with its founders’ “emphasis on innovation” – has released a 52-page report on the FDA’s framework for regulating stem cells and regenerative medicine.

Far from democratic, the report is really a thinly-veiled hit piece on stem cell therapy – one of the few fields of medicine where innovation is actually occurring.

“In many cases, there is little reliable evidence to support claims that these so-called stem cell treatments will have any effect—or indeed that they contain stem cells at all, despite the claims made about them,” the Pew report found. “Beyond the potential physical, psychological, and financial harm to patients, the widespread availability of these unproven treatments could negatively affect the entire field of regenerative medicine.”

On its surface, the report’s professed aims of consumer safety and regulatory clarity are laudable and necessary. However, the report is clearly biased against stem cell clinics and fails to seriously consider the patient perspective in policymaking. And Pew’s curious selection of regenerative medicine “stakeholders” not only diminishes the report’s legitimacy, but reveals troubling undercurrents of industry and agency influence.

Ambiguity and Controversy in Regulatory Policy

The Pew report begins innocuously enough, by laying out the general landscape of regenerative medicine, federal regulation and FDA guidance. The report correctly notes the “complex and rapidly evolving” nature of regenerative medicine, as well as the legal ambiguity that pervades the FDA’s jurisdiction over enforcement.

The report accurately describes the controversy surrounding the FDA’s interpretation of “minimal manipulation” and “homologous use” standards, which determine whether a stem cell product is exempt from the agency’s pre-market approval requirements. It also notes that the FDA’s examples of what uses do or do not meet those standards – as stated in its guidance – are “inconsistent or arbitrary.”

The report’s recommendations are entirely based on stakeholder interviews. All 11 stakeholders supported the FDA’s crackdown on clinics, even though there are plenty of critics who think it is stifling innovation and patient access to stem cell therapy.

Rather than reduce regulation, Pew suggests that additional stakeholders like the Federal Trade Commission, National Institutes of Health and state governments should assist the FDA in its crackdown, adding even more layers of regulatory control.

The report also endorses the online censorship campaign against clinics and goes out of its way to essentially classify Texas and Alabama as “rogue states” for trying to actually expand the availability of stem cell therapy.

Rather than support a balanced and judicious approach that would both promote safety and innovations such as autologous stem cells, the report calls for “tighter control of the industry” to “lend legitimacy to the field and provide regulatory certainty, both of which are essential for developers seeking investment, as well as for payers that will eventually make insurance coverage decisions for these new treatments.”

To be sure, the resolution of regulatory ambiguity is a good thing for all parties. But the ambiguity should not be resolved in a manner that disadvantages the sick and disabled, as well as the small clinics that lack economic leverage to influence agency rule-making. Unfortunately, the Pew report privileges the wealth and influence of the healthcare industry in determining what policies are best. Patients and their interests are unceremoniously relegated to the back of the policy-making bus.

A Suspicious Selection of Stakeholders

As previously stated, the Pew report’s recommendations were derived from stakeholder interviews. Quite laughably, the report maintains that a “broad range of perspectives” were included. Of course, no practicing clinicians were included. Nor were any patient advocates interviewed. However, industry and academia were represented. In fact, one stakeholder was the former Chief Biotechnology Officer and Head of Scientific Strategy and Policy for Johnson & Johnson. Yes, that Johnson & Johnson.

The same Johnson & Johnson that, according to the New York Times, faces more than 100,000 lawsuits over its products. The same Johnson & Johnson that currently faces thousands of lawsuits over claims its baby powder has caused mesothelioma and ovarian cancer. The same Johnson & Johnson that recently agreed to pay a $117 million settlement for deceptive marketing of pelvic mesh implants and $8 billion for playing down the risks of the antipsychotic drug Risperdal. And yes, the same Johnson & Johnson that was found liable in the Oklahoma opioid trial.

So when the Pew report argues that stem cell clinics should be censored and persecuted for offering “dangerous” products and engaging in “deceptive” marketing practices, it is the absolute height of hypocrisy.

To make matters worse, that same former J&J “stakeholder” – who now sits on the board of biotech firm MacroGenics – worked for the FDA for 20 years reviewing and approving biologic products. This is the epitome of policymaking incest.

To appreciate the Pew report’s true motives, all one need do is peruse its references. The report’s end-notes are littered with citations to the work of the most public and commonly interviewed stem cell critics, all of whom are on the record as card-carrying regulationists.

Pew’s cherry-picking of sources reveals its true agenda. It is a meticulously-manicured industry-slanted propaganda piece masquerading as rational, objective stem cell policy.

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 information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The FDA v. Your Stem Cells: An Insider’s View

By A. Rahman Ford, PNN Columnist

Mark Berman, MD, is a key player in the escalating conflict between stem cell therapy providers and the Food and Drug Administration.

Berman is co-founder of the California Stem Cell Treatment Center, a California-based clinic that specializes in stromal vascular fraction (SVF) stem cells, which are autologous cells derived from adipose tissue --- a patient’s own body fat.

Berman and his partner are defendants in a federal lawsuit filed by the FDA. The lawsuit claims that SVF products are considered “drugs” and “biological products” under the  Food, Drug and Cosmetic Act, and thus subject to federal regulation.

In June of this year, a federal judge in Florida upheld the agency’s position in a similar lawsuit against another stem cell company.

Berman maintains that FDA regulations for autologous cells are illegal and wants to set the record straight on the motives behind the agency’s crackdown on stem cells generally and against him and his partner, specifically.

DR. MARK BERMAN

In Berman’s view, the FDA’s assault against autologous stem cells has far less to do with the health, safety and welfare of patients, and much more to do with three other factors:

  1. The pharmaceutical industry’s influence over FDA regulations.

  2. The unfairness of the FDA’s clinical trial process, which preserves the position of large companies at the expense of smaller ones.

  3. The medical establishment’s fear of the paradigm-shifting, market-disrupting effect of healing with one’s own stem cells.

Basic Training in Stem Cell Therapy

Berman was in many respects an accidental recruit to stem cell therapy. A cosmetic surgeon with a private practice in Beverly Hills since 1983, Berman is well known as one of the pioneers of facial rejuvenation using fat grafting.

In 2008, Berman was introduced to equipment developed by Dr. Hee Young Lee of Medikan that harvests fat in specialized syringes. Berman was intrigued and decided to purchase the equipment, which Dr. Lee said could also be used to isolate stem cells.

“Who knew? Plastic surgeons actually pioneered and advanced adipose stem cells,” says Berman.

Over the next couple of years, Berman learned more about adipose-derived SVF and how to isolate it. He also started discussing stem cell trials on orthopedic cases with Dr. Tom Grogan, a colleague in orthopedic surgery.

After a fact-finding mission to Japan in 2010, Berman and Grogan agreed to see patients. One of those patients was Berman’s wife, Saralee, who had significant hip pain after years of running marathons. Saralee was treated with adipose-derived SVF and “has remained pain free to this day,” according to Berman.

Another patient came to Berman for a face lift and said she wanted to get it done because she was scheduled to have both knees replaced in the 2-3 months. Instead, Berman and Grogan treated her knees with SVF cells for free. She demonstrated marked improvement and long-term freedom from pain.

“After seven years, we did a touch-up procedure on her and she continues to be pain free and functional,” says Berman.

In 2010, Berman and urologist Elliot Lander, MD, founded the California Stem Cell Treatment Center. Although successful, Berman and Lander never thought their SVF business would last.

“We figured we’d be good for two or three years of service and then ‘cells in a bottle’ would come along and replace adipose-derived SVF,” Berman told PNN. “It turns out that personal cell therapy may be a massively transformative technology for a variety of reasons and we’re here to stay unless the FDA can illegally have their way with us to protect Pharma and Academia.”

Early on, Berman and Lander treated orthopedic conditions associated with chronic pain – arthritis, back pain and inflammatory conditions. Not only did their patients experience pain relief, they began reporting improvement in other ancillary ailments as well.

“We quickly realized that by filtering the SVF, we could provide the cells via an IV for any variety of conditions,” Berman recalls. “Acute concussion heals overnight. Chronic traumatic brain injury may improve in many cases. Parkinson’s frequently responds well. We’ve had some good response with multiple sclerosis, Alzheimer’s and muscular dystrophy. ALS has not had good results. We’ve seen improvements with chronic heart conditions, COPD, and radiation necrosis following cancer treatments.”

Combating the ‘Unproven’ Disinformation Campaign

Their discoveries led Berman and Lander to publish a SVF safety study involving over 1,500 patients with various degenerative, inflammatory, and autoimmune conditions. They also formed the Cell Surgical Network, a network of physicians who use the same equipment and protocols taught by Berman and Lander. To date, the network has treated over 12,000 patients.

Berman maintains with conviction that “there’s no drug as safe as your own cells.” In fact, he and his family have all had successful personal stem cell treatments, as have most of the affiliate physicians in his network.

Yet news stories about “unproven stem cell procedures” persist. And Google recently went so far as to ban advertising for “unproven or experimental medical techniques,” including most stem cell therapies.

“It is sad and ridiculous that we can safely and effectively treat many people right now, but we’ve been fighting this false press that stem cells are dangerous and unproven when there’s virtually no danger and plenty of proof,” Berman says. 

“Saying it’s unproven denies how science advances. Most science does not rely upon placebo trials, something Pharma routinely takes advantage of to get a new version of an old drug on the market to exploit the public.”

The FDA As Proxy for Big Pharma

Berman has a theory why he and his partner have become targets of the FDA. It has to do with the power and influence of the pharmaceutical industry.

“When corporations get so big, and in this case actually finance government agencies, they end up controlling them in a variety of ways. They have many inside people that can facilitate their needs, but they also have pushed the FDA to write draconian regulations to keep smaller players out of the club as much as possible,” Berman explained.

“Physicians have the obligation to try to help their patients when they can – not to sit around while some sanctimonious academics or Big Pharma or FDA regulatory people decide we can try,” he adds.

Berman poses an intriguing question.

“Isn’t it interesting that no major pharmaceutical company has applied for an IND (new drug application) for personal cell therapy?” he asks.

“The answer is obvious: because they can’t own it.”

Berman believes FDA regulations are designed to protect Big Pharma from competition.

The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.
— Dr. Mark Berman

“Surgeons used to perform a lot more coronary bypass surgery, but Pharma developed stents and drugs to compete for the same patients,” he says. “Pharma and academia are the only two voices that matter to the FDA. The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.”

Berman and Lander intend to fight the FDA in court to the very end. A hearing date was scheduled for this month, but has been postponed until early next year.

“They’re trying hard to ruin us through the press and through these extensively long and unfair court proceedings that have been dragging out for over a year. If it’s not clear, we’re fighting for the basic civil and constitutional rights of our patients,” Berman says.

“We should be achieving new heights in healthcare and freedom yet there are so many people more interested in controlling us than letting us naturally rise to thrive.”

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 information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Stem Cell Therapy for Lower Back Pain Moves Closer

By A. Rahman Ford, PNN Columnist

There’s good news on the horizon for those who suffer from lower back pain due to disc degeneration.

Mesoblast, an Australian biotech company, has partnered with Grunenthal, a large German pharmaceutical company, to commercialize an investigational stem cell product called MPC-06-ID -- a stem cell formula comprised of mesenchymal cells derived from the bone marrow of healthy volunteers. Mesoblast could receive up to $1 billion from Grunenthal if the treatment is successful.

MPC-06-ID is currently in a Phase III placebo-controlled trial in the U.S. In the trial, millions of stem cells grown in a laboratory are injected into the patients’ degenerated discs with the goal of reducing inflammation and causing the discs to regenerate.

In previous trials, 47% of those who received the injection had a significant reduction in pain 12 months later. The results persisted for three years.

The estimated study completion date for the Phase III trial is March 2021. So, unfortunately, there is a bit of a wait. But Mesoblast is hopeful the study findings will result in FDA approval.

The company is also studying a stem cell product for chronic lower back pain. More on Mesoblast’s products and how they treat back pain can be found here.

What does this mean? First and foremost, it’s great news for people suffering from back pain. This is a population that is woefully underserved by conventional medicine. Limited options include analgesics like opioids, which are increasingly difficult to obtain, and spinal surgery that is costly, often ineffective and can even exacerbate the problem. I have previously written about these issues here.

Clinicians around the country have been using stem cell therapy (SCT) for years to treat back pain and even difficult spinal conditions like arachnoiditis. However, these clinics have been operating under the scythe of potential persecution for using products not approved by the FDA.

Not only has this placed them squarely in the crosshairs of regulatory authorities which issue warning letters and file lawsuits, but it has also subjected them to internet censorship by Google and others.

The Mesoblast-Grunenthal partnership is indicative of the fact that major corporate investment in SCT is increasing -- and that can be a great thing for consumer choice. More and more biotech investors are recognizing that SCT is the future of medicine, especially when it comes to treating conditions caused by chronic inflammation. Forbes reports that the market size of the SCT industry was $8.65 billion in 2018, with a projected annual growth rate of 8.8%.

We saw recent evidence of this trend with Bayer’s acquisition of Bluerock Therapeutics’ and its stem cell treatments for Parkinson’s disease and other chronic illnesses. And Boston-based Vertex Pharmaceuticals recently acquired Semma Therapeutics for $950 million in a bet that its SCT products could cure type 1 diabetes.

Why is the SCT market so robust? Transparency Market Research attributes it to a “rise in consumer awareness.” In other words, people are desperate for relief and looking for new treatments. Suffice it to say, any additional treatment option for those suffering from back pain is more than welcome.

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 information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.