Stem Cells Can Restore Movement in Paralyzed Patients

By Pat Anson, PNN Editor

Stem cells derived from body fat can improve sensation and restore movement in patients paralyzed by a severe spinal cord injury, according to a small clinical trial at the Mayo Clinic. One man who was paralyzed from the neck down after a surfing accident is now able to walk again after getting stem cell therapy.

"This study documents the safety and potential benefit of stem cells and regenerative medicine," first author Mohamad Bydon, MD, a Mayo Clinic neurosurgeon, said in a press release. "In spinal cord injury, even a mild improvement can make a significant difference in that patient's quality of life."

The ten patients who participated in the Phase 1 study had adipose (fat) stem calls removed from their abdomen or thigh. After several weeks, 100 million new mesenchymal stem cells (MSCs) grown in a laboratory petri dish were injected into each patient’s lumbar spine. It’s believed the cells then migrate to the injured part of the spine. Participants were regularly followed for the next two years to assess their response to treatment.

The study findings, published in the journal Nature Communications, show that 7 of the 10 patients showed improvement based on the American Spinal Injury Association’s Impairment Scale. Improvements included increased sensation when tested with a pinprick or light touch, increased muscle strength, and the recovery of voluntary bowel function. Three patients showed significant improvement, four had a moderate improvement, and three had no response.

This Mayo Clinic video shows how the process works:

Perhaps the most dramatic improvement was in Chris Barr, a California man who was paralyzed in 2017 while surfing near San Francisco. He broke his neck in eight places when his head hit the ocean floor.

Barr was the first person enrolled in the Mayo study. Eighteen months after the stem cell injection, Barr was able to walk again and continues to show improvement in his mobility and quality of life.

"I never dreamed I would have a recovery like this," Barr told ABC News. "I can feed myself. I can walk around. I can do day-to-day independent activities."  

No serious adverse events were reported from the stem cell treatment. The most common side effects were headaches and musculoskeletal pain that went away after over-the-counter medications were taken.

Since safety is the primary goal of a Phase 1 study, further research will be needed to assess the improvements in movement and sensation. The use of fat-derived stem cells for spinal cord injury is considered experimental by the Food and Drug Administration.

According to the National Spinal Cord Injury Statistical Center, nearly 300,000 Americans currently suffer from a spinal cord injury, costing the healthcare system over $40 billion annually.  The estimated lifetime cost for each patient can reach millions of dollars.

The spinal cord has limited ability to repair itself. Patients who suffer a significant injury typically experience most of their recovery in the first six to 12 months. Improvements generally stop 12 to 24 months after an injury. Only about 5% of people who are paralyzed can expect to regain any feeling or movement.

"For years, treatment of spinal cord injury has been limited to supportive care, more specifically stabilization surgery and physical therapy," Dr. Bydon says. "Many historical textbooks state that this condition does not improve. In recent years, we have seen findings from the medical and scientific community that challenge prior assumptions. This research is a step forward toward the ultimate goal of improving treatments for patients."

Opioid Guidelines Leave Some Surgery Patients in Pain

By Pat Anson, PNN Editor

In recent years, many U.S. hospitals have adopted policies that reduce or eliminate the use of opioids during and after surgery.

Patients at Houston Methodist Hospital, for example, are getting acetaminophen (Tylenol) for post-operative pain after hernia repairs and other minimally invasive surgeries. And dozens of hospitals in Michigan have adopted guidelines for post-operative pain that have significantly reduced the use of opioids.

But a new study presented at the annual meeting of the American College of Surgeons suggests that policies that discourage the use of opioids for post-operative pain may be neglecting patients that need opioids for better pain control.

“The key findings of our study are that we were able to successfully reduce how many opioids we were prescribing for patients after operations using evidence-based guidelines,” said lead author Cornelius Thiels, DO, a surgical oncology fellow at Memorial Sloan Kettering Cancer Center and a researcher at the Mayo Clinic.

“However, the other finding of our research is that there’s still additional room to improve in terms of making sure all patients after surgery have their pain well controlled.”

The researchers evaluated 138 patients who had one of 12 elective surgeries after the Mayo Clinic adopted guidelines in 2018 that call for “multimodal pain control,” a combination of opioids with non-opioid pain relievers such as ibuprofen, naproxen and acetaminophen. Those patients were compared with 603 patients who had the same procedures before the guidelines, when opioids were used more widely.

While most patients in the post-guideline group were satisfied with their pain control after discharge, a significant number were not.

In telephone surveys conducted about four weeks after discharge, the percentage of patients in the post-guideline group who were dissatisfied with their pain control was more than double that of the pre-guideline group (9.4% vs. 4.2%). The percentage who said they were not prescribed enough pain medication was also higher (12.5% vs. 4.9%).

“There is a small subset of patients who we’re not optimally managing yet, and this study confirmed that this is a small number,” Thiels said. “However, I think that’s a critically important subset of patients.”

Thiel says about half of patients need opioid medication after major surgeries, and doctors need to do a better job identifying who they are.

“Our goal is to give them the exact right amount so that we limit the number of un-used opioids in our community while also making sure we don’t reduce it down too far and then leave them in pain,” he said. “The right answer may be more non-opioid based pain medications, better patient education and setting of expectations, or in some cases patients may actually require slightly more opioid medications, and that is OK.”  

Opioid addiction is actually rare after surgery.  A large 2016 Canadian study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in the British Medical Journal found only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or had a non-fatal overdose.

Therapy Dogs Give Relief to Fibromyalgia Patients

By Pat Anson, PNN Editor

It’s well-known that having a pet or support animal can provide significant psychological benefits to people suffering from stress, anxiety or loneliness. A new study at the Mayo Clinic suggests that pet therapy can also help people with fibromyalgia.

To gain a better understanding of the physiological and emotional benefits of pet therapy, researchers monitored the hormones, heart rate, temperature and pain levels of 221 patients enrolled in the Mayo Clinic Fibromyalgia Treatment Program. Half of the participants spent 20 minutes interacting with a therapy dog and its handler, while the other half served as a control group, spending the same amount of time with the handler only.

The research findings, recently published in Mayo Clinic Proceedings, are striking. People who interacted with a therapy dog had a statistically significant increase in levels of salivary oxytocin – a hormone released by the pituitary gland that is known as the “cuddle hormone” or “love hormone.”

They were also more relaxed, their heart rates decreased, and they reported more positive feelings and fewer negative ones compared to the control group. Over 80% agreed or strongly agreed that animal therapy was helpful to them.  

Pain levels declined in both groups, but there was a larger decrease in those who interacted with the therapy dogs. On average, severe pain scores in that group dropped to more moderate levels.

“Given that individuals with FM (fibromyalgia) suffer pain chronically, this reduction, even if numerically minimal, could help to provide symptomatic relief and quality of life improvement,” researchers concluded. “Overall, the study showed that a 20-minute human-animal interaction (treatment group) as well as a human-human interaction (control group) could improve the emotional and physiological state of patients with FM; however, those who interacted with a therapy dog showed a more robust improvement.”

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Its cause is unknown and many treatments prove ineffective. 

Therapy Dogs Calmer

The Mayo Clinic study was unique in another way – because researchers monitored and collected saliva from the dogs to see how they responded to the therapy sessions. Although therapy dogs are used in a wide variety of clinical settings, little is known about the impact of therapy sessions on the emotional state of the dogs.

Researchers say the 19 dogs involved in the fibromyalgia study -- all members of the Mayo Clinic Caring Canines program – did not show signs of stress, appeared to be more relaxed, and had significantly lower heart rates at the end of the sessions, a sign that they enjoyed interacting with patients.

"We need to expand our understanding of how animal-assisted activity impacts therapy dog's well-being, and this sizeable study with 19 dogs of various breeds provided solid evidence that animal-assisted activity done in the right condition does not have negative impacts on well-trained therapy dogs," said François Martin, PhD, a researcher for Purina, which sponsored the study.

"This only encourages us to do more research to continue to demonstrate the power of the human-animal bond on people while ensuring assistance animals also experience positive wellness as a result of their work."

You don’t need a trained therapy dog to enjoy the benefits of having a pet. A recent survey of older adults found that dogs, cats and other pets help their owners enjoy life, reduce stress, keep them physically active, and take their minds off pain.

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.

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.

Is Tramadol Just as Addictive as Other Opioids?

By Pat Anson, PNN Editor

Patients recovering from surgery who take the opioid tramadol have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids, according to a large Mayo Clinic study.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have been increasing because it is widely perceived as a “safer” opioid with less rick of addiction. The new study, published in The BMJ, appears to debunk that claim, at least for surgery patients.

Mayo Clinic researchers looked at health data for over 350,000 patients who were prescribed opioids after undergoing 20 common surgeries in the U.S. between 2009 and 2018. A little over 7% of the patients were still refilling opioid prescriptions 90-180 days later. When the researchers dug a little deeper into the data, they found that patients taking tramadol had a 6 percent higher risk of prolonged use compared to other opioids.  

"This data will force us to reevaluate our postsurgical prescribing guidelines," says lead author Cornelius Thiels, DO, a general surgery resident in Mayo Clinic School of Graduate Medical Education. "While tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids."

Tramadol is a synthetic opioid that was classified as a Schedule IV controlled substance by the Drug Enforcement Administration in 2014, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse.

Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

Over half (53%) of the patients in the Mayo Clinic study were prescribed hydrocodone, about a third (37.5%) received oxycodone (also a Schedule II drug) , and only 4% received tramadol.

"We found that people who got tramadol were just as likely as people who got hydrocodone or oxycodone to continue using opioids past the point where their surgery pain would have been expected to be resolved," said senior author Molly Jeffery, PhD, the scientific director of research for the Mayo Clinic Division of Emergency Medicine. "This doesn't tie to the idea that tramadol is less habit forming than other opioids."

Jeffery and his colleagues say the DEA and FDA should consider reclassifying tramadol to a level that better reflects the risk of prolonged use.

"Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention," said Thiels.

In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.

Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is an unscheduled drug in Canada, but Health Canada is currently reviewing its status.

Elite Hospitals Offering Unproven Stem Cell Treatments

By Liz Szabo, Kaiser Health News

The online video seems to promise everything an arthritis patient could want.

The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and “regenerative medicine” for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, “It’s completely healed.”

Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.

“I don’t have any pain that stops me from doing anything I want,” Hyland says.

The video’s cheerleading tone mimics the infomercials used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said Dr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine.

But the marketing video wasn’t filmed by a little-known operator. It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area.

Swedish is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

Hospitals say they’re providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The Food and Drug Administration is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to several cases of blindness and at least 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a handful of exceptions, as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.

Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic's campus in Florida.

‘Expensive Placebos’

While hospital-based stem cell treatments may be legal, there’s no strong evidence they work, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published a series of articles describing the size and dynamics of the stem cell market.

“FDA approval isn’t needed and physicians can claim they aren’t violating federal regulations,” Turner said. “But just because something is legal doesn’t make it ethical.”

For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay more than $700 a treatment for platelets and up to $5,000 for fat and bone marrow injections. As a bonus, doctors don’t have to wrangle with insurance companies, which view the procedures as experimental and largely don’t cover them.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business. It preys on people’s desperation.”

— Dr. James Rickert

“It’s an out-of-pocket, cash-on-the-barrel economy,” Turner said. Across the country, “clinicians at elite medical facilities are lining their pockets by providing expensive placebos.”

Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It preys on people’s desperation.”

In a joint statement, Pourcho and Swedish defended the online video.

“The terminology was kept simple and with analogies that the lay person would understand,” according to the statement. “As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.”

But Knoepfler said the guests on the video make several “unbelievable” claims.

At one point, Dr. Pourcho says that platelets release growth factors that tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and “so you don’t get, say, eyeball in your hand.”

Knoepfler, who has studied stem cell biology for two decades, said he has never heard of “any possibility of growing eyeball or other random tissues in your hand.” Knoepfler, who wrote about the video in February on his blog, The Niche, said, “There’s no way that the adult brain could send that kind of stem cells anywhere in the body.”

The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called “New Day Northwest.”

Although much of the show is produced by the KING 5 news team, some segments—like Pourcho’s interview—are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.

After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn’t labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.

“The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material,” Rose said. “We value the public’s trust.”

Increasing Scrutiny

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson’s disease and other serious diseases.

In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called “bad actors.”

With more than 700 stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.

“There are clearly bad actors who are well over the line and who are creating significant risks for patients,” Gottlieb said.

“Products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket.”

— Scott Gottlieb, FDA Commissioner

Gottlieb, set to leave office April 5, said he’s also concerned about the financial exploitation of patients in pain.

“There’s economic harm here, where products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket,” Gottlieb said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there is a broad “spectrum” of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are “for just about anything.” Hospitals operate somewhere in the middle, Marks said.

“The good news is that they’re somewhat closer to the most rigorous academics,” he said.

The Mayo Clinic’s regenerative medicine program, for example, focuses conditions such as arthritis, where injections pose few serious risks, even if that’s not yet the standard of care, Shapiro said.

Rickert said it’s easy to see why hospitals are eager to get in the game.

The market for arthritis treatment is huge and growing. At least 30 million Americans have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet-rich plasma (PRP) injections for arthritis generated more than $93 million in revenue in 2015, according to an article last year in The Journal of Knee Surgery.

“We have patients in our offices demanding these treatments,” Shapiro said. “If they don’t get them from us, they will get them somewhere else.”

Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In a paper published this year, Shapiro described the hospital’s consultation service, in which doctors explain patients’ options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.

“Most of the patients do not get a regenerative [stem cell] procedure,” Shapiro said. “They don’t get it because after we have a frank conversation, they decide, ‘Maybe it’s not for me.’”

Lots of Hype, Little Proof

Although some hospitals boast of high success rates for their stem cell procedures, published research doesn’t back up those claims, Rickert said.

The Mayo Clinic website says that 40 to 70 percent of patients “find some level of pain relief.” Atlanta-based Emory Healthcare claims that 75 to 80 percent of patients “have had significant pain relief and improved function.” In the Swedish video, Pourcho claims “we can treat really any tendon or any joint” with PRP.

The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.

But PRP hasn’t been proven to help every part of the body, he said.

PRP has been linked to serious complications when injected to treat patellar tendinitis, an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.

“People will say, ‘If you inject PRP, you will return to sports faster,’” said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. “But that hasn’t been proven.”

A 2017 study of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that’s nothing to brag about, Rickert said, given that hyaluronic acid therapy doesn’t work, either. While some PRP studies have shown more positive results, Rickert notes that most were so small or poorly designed that their results aren’t reliable.

In its 2013 guidelines for knee arthritis, the American Academy of Orthopaedic Surgeons said it is “unable to recommend for or against” PRP.

“PRP is sort of a ‘buyer beware’ situation,” said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. “It’s the poor man’s approach to biotechnology.”

Tests of other stem cell injections also have failed to live up to expectations.

Shapiro published a rigorously designed study last year in Cartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70 percent of patients, Fu said.

A 2016 review in the Journal of Bone and Joint Surgery concluded that “the value and effective use of cell therapy in orthopaedics remain unclear.” The following year, a review in the British Journal of Sports Medicine concluded, “We do not recommend stem cell therapy” for knee arthritis.

Shapiro said hospitals and health plans are right to be cautious.

“The insurance companies don’t pay for fat grafting or bone-marrow aspiration, and rightly so,” Shapiro said. “That’s because we don’t have enough evidence.”

Rickert, an orthopedist in Bedford, Indiana, said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn’t be charged for these services until they’ve been tested and shown to work.

Orthopedists—surgeons who specialize in bones and muscles—have a history of performing unproven procedures, including spinal fusion, surgery for rotator cuff disease and arthroscopy for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.

Misleading Marketing

Some argue that joint injections shouldn’t be marketed as stem cell treatments at all.

Piuzzi said he prefers to call the injections “orthobiologics,” noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said.

Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There’s no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don’t know why some patients who receive platelet injections feel better, but others don’t.

So, it comes as no surprise that many patients have trouble sorting through the hype.

Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.

When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, “it seemed like an answer to a prayer,” said Walsh, of Stuart, Florida. “You’re so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.”

The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. “My only regret,” she said, “is that I wasted so much time and money.”

Kaiser Health News (KHN) is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Mayo Clinic: Opioid Prescribing Has Not Changed

By Pat Anson, Editor

Numerous studies have shown that opioid prescriptions are falling. The trend started in 2011 and appears to have accelerated since the release of the CDC’s 2016 opioid prescribing guidelines.

The volume of opioid medication filled last year fell by 12 percent, the largest decline in 25 years, according to the IQVIA Institute.  Prescriptions for hydrocodone – once the most widely prescribed drug in the country – have fallen by a third since their peak. Even the CDC has reported that opioid prescriptions have dropped by about 5% each year between 2012 and 2016.

Anecdotally, many patients tell us opioids are harder, if not impossible, to obtain. Nearly half of the 3,100 patients PNN surveyed last year said they were getting a lower dose. And one in four said they were no longer prescribed opioids.

But according to Mayo Clinic researchers, opioid prescribing hasn't changed that much and remains at high levels. In a study published in the British Medical Journal (BMJ), they report that opioid prescriptions for Medicare and privately insured patients have remained relatively stable over the past few years. And the average daily dose of opioids is well above what it was 10 years ago.

“If you’re hearing the message that prescription opioid use is starting to decline, I think we need to counter that message and say in most populations it really isn’t moving very much.” says lead author Molly Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Our data suggest not much has changed in prescription opioid use since about five years ago.”

Why the discrepancy? Jeffrey says most of the previous studies only looked at market-level data – the amount of opioids that drug makers reported producing and selling. She and her colleagues dug a little deeper, looking at insurance claims for 48 million U.S. patients between 2007 and 2016.  

Over that 10-year period, the rate of opioid use by privately insured patients remained relatively flat at 6 to 7 percent. The average daily dose for that group, about two pills of 5-milligram oxycodone, remained the same.

The rate of opioid use by Medicare patients 65 and older peaked at 15% in 2010 and decreased slightly to 14% by 2016. Their average daily dose, three 5 mg pills of oxycodone, also remained relatively unchanged.

Rates of opioid use by disabled Medicare patients also haven't changed much, peaking at 41% in 2013 and falling to 39% in 2016. Their average daily dose remains relatively high, about eight 5 mg oxycodone pills. 

“Our research of patient-level data doesn’t show the decline that was found in previous research,” says Jeffery. “We wanted to know how the declines were experienced by individual people. Did fewer people have opioid prescriptions? Did people taking opioids take less over time? When we looked at it that way, we found a different picture.”

The Mayo study includes an interesting disclaimer. While the researchers looked at data from patient insurance claims, they never surveyed or spoke to any patients about their opioid use. The researchers said they would “engage” with patients in future blog posts and press releases.

You can share your views with Molly Jeffery by email at jeffery.molly@mayo.edu or @mollyjeffery on Twitter.

Is Vitamin D Making Me Feel Better?

By Crystal Lindell, Columnist

This is the story of how I have turned into the crazy lady constantly telling everyone I meet to get their vitamin D level tested.

The thing about the vitamin D is that it could either be the cure I’ve been searching for, or have absolutely nothing to do with why I’ve been feeling better since about July. Either way though, I am feeling better these days.

Back in May, I went to visit a local weight loss clinic to try and lose some of the 60 lbs. I’ve gained since getting sick. While I was there they ran some routine blood work. And it turns out my vitamin D was low. Not like, “Oh, it’s just a little low, you should probably take a supplement” low.

My level was 6 ng/ml. It was literally the lowest the doctor at the weight loss clinic had ever seen.

To put it in perspective, the Vitamin D Council says it’s best to be between 40-80 ng/ml, while the University of Wisconsin recommends being between 30-80 ng/ml.

I had tested low before, like 19 ng/ml, but it was years before I suddenly woke up feeling like someone was stabbing me in the ribs. And I honestly don’t remember the doctor at the time impressing on me that it was any sort of an issue. I just figured it was like needing an oil change every 3,000 miles. Sure that’s the ideal, but your car isn’t going to just shut off if you wait until 5,000 miles.

So I told my primary care doctor about the results, and he and the weight loss doctor decided to put me on prescription-strength 50,000 IU vitamin D for three months, followed by a daily dose of 4,000 IU after that.

When I got home from my appointment, I looked through all my medical records — from Loyola University, the Mayo Clinic and the University of Wisconsin-Madison — and realized that not once had anyone thought to test my vitamin D.

I have literally had more than 35 blood tests, a handful of urine tests, and a more imaging than is probably healthy, but none of them were for vitamin D!

It turns out vitamin D is pretty important though, and has been shown to have direct links to chronic pain. It’s also not actually a vitamin, so much as a hormone. There’s all sorts of research on how low vitamin D can cause chronic pain, even specifically rib pain, which is what I have.

A recent study in The Pain Physician journal shows that, "Vitamin D, a hormone precursor essential for maintaining homeostasis of the musculoskeletal system, has long been proposed as an associated factor in CWP (chronic widespread pain). The most severe type of hypovitaminosis D, osteomalacia, features generalized body pain, especially in the shoulder, rib cage, and lumbar and pelvic regions."

And another study from the American Academy of of Pain Medicine showed that, “The prevalence and clinical correlates identified in this pilot study provide the basis for the assertion that vitamin D inadequacy may represent an under-recognized source of nociception and impaired neuromuscular functioning among patients with chronic pain.”

In other words, if low levels aren’t the cause, not having enough vitamin D can make chronic pain more severe. And, low Vitamin D can also make pain medications less effective.

According to an article on the Mayo Clinic website, “patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication — nearly twice as much — as those who had adequate levels.”

So I was cautiously optimistic that getting my vitamin D levels back up could at the very least make my pain medications more effective.

But for the first few months, I didn’t really feel much different. I only told a few people about the vitamin D because constantly talking about possible cures is exhausting — everyone wants it to work so much, and then when it doesn’t you feel like you have personally failed at something.

So I only told my mom, my boyfriend at the time, and my best friend. My then-boyfriend was hoping for a miracle by day two. But alas, nothing. My best friend was hoping for a miracle by month two. But alas, nothing. And my mom, who I live with, wasn’t really putting her hope in it all. She had seen too many things not work.

But then, in July, I started noticing things. Like little things. Like I could go for a walk and not die afterward. And then, in August, I cleaned the freaking bathroom! Seriously, I did the floors, washed the mirrors and scrubbed the tub, all without ending up in the hospital!! And by September, I was even able to make the four-hour round trip trek to work without having to spend the entire next day recovering.

Slowly, but surely, I have started feeling better. I mean, I’m not cured. And I’m not holding my breath that I ever will be. I’m also completely aware of the fact that I could backslide at any moment.

And, I still take morphine on a daily basis, for now anyway. But I have literally gone off almost all my other meds, including the sleeping pill amitriptyline and the nerve pain medication Cymbalta. As for the hydrocodone, I’m down to like one or two pills a week at the most. And sometimes, I can go the whole week without taking any at all — which is pretty much a miracle of God if there ever was one.

There’s also been some weight loss. I honestly never went back to the weight loss clinic because they wanted to put me on a weight loss drug, and over the last couple years I’ve come to a place where I just don’t want to be on any drugs unless I have to.

Even so though, feeling better has meant that I’ve been able to walk three to five miles about six days a week all summer, and I’m excited to report that since May I’ve lost 30 pounds! WHAT?

I had a visit with my amazing doctor last week, and we talked about whether or not the vitamin D deserved any credit for my newfound ability to shower almost every single day.

When I showed him that I had a whole bottle of hydrocodone left over — I honestly used to run out of the drug a week early each month — he literally said, “Congratulations!”

He tested my vitamin D, and I’m happy to report that I’m now at 35 ng/mL — a much healthier level than six. As my doctor remarked on the top of the lab results, “Your vitamin D level looks good. You can safely keep taking your current dose of vitamin D supplements.”

When we talked about it during the appointment, he told me that the vitamin D could be part of why I’m feeling better, or it could be that the nerve that they think was causing the pain had shifted somehow. Or it could be something else all together. Maybe it’s the placebo effect, or maybe it’s all those Taco Bell Cheesy Gordita Crunches I eat every other day that have something magical in them.

So yeah, I don’t know if the vitamin D is the reason I’m feeling better or how long-term this could be, but honestly, I don’t care. I’m just happy that I can clean the bathroom again.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It 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.