Injection of Donor Cells Gives Long-Term Relief from Degenerative Disc Disease

By Pat Anson, PNN Editor

A single injection of cells and fluid derived from human donor tissue was successful long-term in relieving pain and restoring physical function in patients with degenerative disc disease, according to new research presented at the annual meeting of the Society of Interventional Radiology in Phoenix.

The injections, known as viable disc allograft supplementation, encourage cells in damaged discs to regenerate with healthy tissue. Degenerative disc disease is one of the leading causes of chronic lower back pain.

“The significant improvement in pain and function is promising for patients living with chronic low back pain – a condition that can greatly impact a person’s quality of life,” said lead author Douglas Beall, MD, chief of radiology at Clinical Radiology of Oklahoma. “Back pain is the leading cause of limited activity and workplace absenteeism. This treatment may help patients return to a normal activity level for a longer period time.”

Fifty patients participated in the VAST trial, with 46 patients receiving allograft treatment and four receiving saline injections as a placebo. VIVEX Biologics, a regenerative medicine company that processes donated cells and tissue to treat musculoskeletal injuries, wounds and burns, sponsored the study.

After three years, 60 percent of patients who received allograft treatment reported more than 50% improvement in pain and 70% had significant improvement in their function scores. No patients suffered adverse effects.

In healthy patients, discs cushion the spine’s vertebrae, facilitating movement and flexibility. But discs can wear out over time and cause the bones of the spine to rub together and pinch nerves, causing pain and disability. By age 60, most people have at least some disc degeneration.

“Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived,” said Beall, who is a medical consultant for VIVEX. “We need better treatments for this condition since conservative care is not providing the long-term outcomes that patients deserve. Injectable allograft treatment might be the answer for many people.”

Beall says allograft injections could decrease the use of pain medication by patients with chronic lower back pain. The treatment requires no incisions and patients are able to go home on the same day.

Other companies are also developing new injections to treat degenerative disc disease. In clinical trials, Australia-based Mesoblast says injections of its proprietary stem cell product provided long-term relief for people with lower back pain caused by disc disease. The company recently announced the FDA designated its stem cell injection as a Regenerative Medicine Advanced Therapy, which is designed to help speed up its development.   

Injections of an experimental gel developed by ReGelTec also show promise as a treatment for disc disease. The hydrogel is heated before injection to more easily fill cracks and tears in the affected discs. When the gel cools and hardens, it helps restore the disc’s structural integrity.   

Promising Results for Stem Cell Treatment of Degenerative Disc Disease

By Pat Anson, PNN Editor

An Australian regenerative medicine company has released positive results from a Phase III randomized trial showing that a single injection of its proprietary stem cell product can provide long-term relief for people with chronic lower back pain caused by degenerative disc disease.

Mesoblast Limited said the results are so promising it plans to meet with the U.S. Food and Drug Administration to discuss ways to accelerate approval of the drug as a treatment that reduces the use of opioid pain medication.

The company’s stem cell product -- remestemcel-L -- has been under development for several years. It uses mesenchymal precursor cells taken from the bone marrow of healthy donors to reduce inflammation by inhibiting the production of pro-inflammatory cytokines by white blood cells.

Sixty percent of the patients in the clinical trial who were injected with remestemcel-L reported minimal or no pain after 12 months. After 24 months, 54 percent reported little or no pain, with the greatest pain reduction in patients in the early stages of degenerative disc disease. Many patients also significantly reduced their use of opioids during the study period.

“The durable pain reduction for at least two years from a single administration indicates that rexlemestrocel-L has the potential to change the treatment paradigm for chronic low back pain due to inflammatory disc disease, a condition that affects as many as seven million patients across the United States and Europe, and to prevent or reduce opioid use and dependence,” Dr. Silviu Itescu, CEO of Mesoblast, said in a statement.

Over 400 patients were enrolled in the Phase III trial, which was conducted at 48 sites around the world, mostly in the United States. Although Mesoblast told physicians and patients not to change any medications during the trial, after 24 months there was a 40% reduction in opioid use in patients injected with rexlemestrocel-L. Those who were given a placebo saline injection increased their daily opioid consumption.

In a previous study of patients with chronic lower back pain who did not respond to conventional treatment, a single injection of remestemcel-L also reduced pain for at least two years.

The FDA has prioritized the development of new pain treatments that reduce the use of opioids. Although the agency has taken a dim view of some stem cell therapies as “unproven and potentially dangerous,” Mesoblast believes the FDA will be more open-minded about its rexlemestrocel-L treatment. Last year the agency approved an investigational new drug application for rexlemestrocel-L as a therapy for COVID-19.

“We now have two studies that show significant pain reduction and we’re fully prepared to have a discussion with FDA on a path forward,” said Mesoblast Chief Medical Officer Dr. Fred Grossman. “We’re going to get into discussions to see if there’s an accelerated path. Or, if we do need to do another study, we now have a very defined patient population where we see significant pain reduction.”

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.

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.

Study Tests Stem Cells for Degenerative Disc Disease

By Pat Anson, Editor

An Australian biotech company is testing a new stem cell treatment for degenerative disc disease.

Mesoblast is enrolling patients in a Phase 3 study to see if a single injection of mesenchymal precursor cells (MPCs) taken from the bone marrow of healthy donors can relieve back pain and improve the mobility of patients with disc disease, which occurs when the cushions between vertebrae wear down because of aging, genetics or injuries.

Millions of MPCs are injected directly into the damaged disc in an outpatient procedure. Previous studies have found that MPCs have anti-inflammatory effects, and help strengthen and improve the stability of damaged discs. The treatment is being developed for patients who have exhausted other options for their back pain.

“Patients with this level of degeneration often try multiple treatments for relief, including pain medication, massage, physical therapy, chiropractic adjustments and acupuncture,” says lead investigator Kee Kim, MD, professor of neurological surgery and co-director of the University of California Davis Spine Center.

“For some of them, nothing seems to help, and we end up operating to remove the degenerated disc and fuse the spine to eliminate motion that may cause increased pain. We want to know if a single dose of this investigational therapy can offer relief without the need for surgery.”

UC Davis is one of 28 sites in the United States and Australia involved in the study. Participants with degenerative disc disease in the lower back will receive injections of either MPCs, MPCs with a carrier material (hyaluronic acid) or a placebo. Although the MPCs are collected from donors, tissue matching is not necessary.

Following treatment, participants will be evaluated by researchers six times over the course of a year. They also will be given the option to participate in an extension of the study to track their progress for three years after the initial injection.

Previous studies have found that MPCs have anti-inflammatory effects, and help strengthen and improve the stability of damaged discs. Researchers caution, however, that the treatment may not be effective for everyone.

“Many patients with back pain will not benefit from this stem cell therapy and may still require surgery,” Kim said. “For some patients, it could offer improvement. For these patients, it is worth exploring this alternative.”

You can find out more about the study by clicking here.

Stem Cell Study for Back Pain Begins

By Pat Anson, Editor

Enrollment has begun in a clinical study of an experimental stem cell therapy that could – if proven successful – revolutionize the treatment of low back pain caused by degenerative disc disease.

About 330 adults with chronic low back pain who have not responded to conventional therapy will be enrolled in the Phase III “Cascade” study at over two dozen medical centers in the United States. Participants will be injected in the lumbar disc with millions of Mesenchymal Precursor Cells (MPCs) – adult stem cells derived from donated bone marrow.

An earlier Phase II study showed that a single injection of a 6 million cell dose of MPCs reduced low back pain and improved function for at least 12 months. Participants also used fewer opioids for pain relief and required less treatment.

“If you look at the study as a whole, people who received the 6 million stem cell injection into the disc, 70 percent of them had a reduction of their pain of 50% or greater. These were clinically relevant changes,” said J. Scott Bainbridge, MD, lead investigator at Denver Back Pain Specialists, one of the clinics participating in the Cascade study.

"The clinical program is the first of its kind in the United States and we are very excited by the potential of these adult stem cells to provide a novel therapeutic approach."

Bainbridge says the stem cell injection takes up to two months to stop the pain and inflammation triggered by degenerative disc disease.

“It takes time for the stems cells to normalize the inflammatory condition,” Bainbridge told Pain News Network. “You’re taking a disc that is on a degenerative cascade or path. The stem cells regulate that, they change it from an inflammatory stage to an anti-inflammatory, homeostatic state. It turns on the engine, if you will, to start building and producing some of the things that will help the disc become hydrated and build back some of its structural integrity.”    

Degenerative disc disease is the most common cause of low back pain, which develops with the gradual loss of proteoglycan, a substance that cushions the bones of the spine and enables normal motion.

Conventional treatment includes pain medication, physical therapy or surgical intervention such as a spinal fusion. Bainbridge says stem cell injections have the potential to become a frontline treatment, to be used before a riskier treatment such as surgery.

The Cascade study is sponsored by Mesoblast Limited, an Australian company focused on cell-based regenerative medicine. Mesoblast is also developing stem cell treatments for rheumatoid arthritis and diabetic neuropathy, using “off-the-shelf” stem cells from healthy adult donors that do not require tissue matching.

“(There) is compelling evidence that Mesoblast’s stem cell technology has the potential to change the treatment of spinal disease from focusing on surgical reconstruction to biologic regeneration. Physicians and patients are seeking access to a new modality to treat patients with this highly debilitating disease for whom there are limited options,” said Hyun Bae, MD, Medical Director at the Cedars-Sinai Spine Center in Los Angeles, which participated in the Phase II study.

Unfortunately, it could take years for the therapy to win approval from the U.S. Food and Drug Administration. The Cascade study alone is expected to take about three years. For further information about the study and a list of the 25 clinics that are recruiting participants, click here.