Stem Cells Restore Function in Patients Paralyzed by Spinal Cord Injuries

By Pat Anson, PNN Editor

Intravenous injection of mesenchymal stem cells (MSCs) in patients paralyzed by spinal cord injuries led to significant improvement in their motor functions, according to a team of researchers at Yale University and Sapporo Medical University in Japan.

The study findings, published in the Journal of Clinical Neurology and Neurosurgery, focused on 13 patients who suffered spinal cord injuries (SCIs) after falls or trauma. Some lost the ability to use their arms and legs, while others suffered coordination and sensory loss, or experienced bowel and bladder dysfunction.

For more than half of the patients, substantial improvements in motor function were observed within weeks of being injected with autologous MSCs derived from their own bone marrow. Although this was a small observational Phase 2 study, researchers are excited by the findings.

"The idea that we may be able to restore function after injury to the brain and spinal cord using the patient's own stem cells has intrigued us for years," said senior author Stephen Waxman, MD, a professor of neurology, neuroscience and pharmacology at Yale. "Now we have a hint, in humans, that it may be possible."

One of the patients profiled was a 34-year-old man who was left partially paralyzed and bedridden after a fall. He received an intravenous injection of MSCs 47 days after his injury. Two weeks after the infusion, voluntary movement was restored to his lower extremities and he was walking with the support of a walker.

In another case, a 47-year-old man left bedridden after a diving accident showed rapid improvement after a stem cell infusion. He was able to drive a wheelchair the next day, walk and climb stairs after two weeks, and eat independently after eight weeks.

Other patients paralyzed after similar injuries were able to breath again without assistance, regain control of their bowel functions, and perform independent living tasks such as dressing and grooming.

“Although this initial case study was unblinded and uncontrolled, the SCI patients appeared to demonstrate a tendency of relatively rapid improvement of neurological function that was often apparent within a few days following infusion of MSCs,” researchers said.

“We would emphasize that this case series describes an early study on a small number of patients. In addition to being unblinded and uncontrolled, this study has a number of limitations. We cannot rule out observer bias nor a contribution of surgical intervention to recovery in cases where this intervention occurred, or spontaneous recovery.”

Other case studies have also shown that stem cells can restore motor and sensory function in patients paralyzed by spinal cord injuries.

The Mayo Clinic reported in 2019 that a California man paralyzed from the neck down in a surfing accident was able to walk again after being injected with his own stem cells. Researchers emphasized the man was a “super-responder” and that other paralyzed patients injected with stem cells don’t have such a dramatic recovery.

According to the National Spinal Cord Injury Statistical Center, over 17,000 Americans suffer spinal cord injuries each year. 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.

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.

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.

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“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.