Have We Reached the Stem Cell Tipping Point?

By A. Rahman Ford, PNN Columnist

One morning while watching TV, I was astonished by one of the commercials that ran.  It was an ad for stem cell therapy.  That was when it dawned on me – stem cells had finally hit the mainstream.  It was no longer a procedure of myth and mystery that people saw as strange or taboo.  It was now real, obtainable and, dare I say, normal. 

The public discourse over the legitimacy of stem cell therapy (SCT) has taken a clear turn in recent years, away from fearmongering and misrepresentation, and toward medical innovation and less restrictive federal regulation. 

Stem cell therapy may have officially reached its tipping point.

The term “tipping point” was popularized by Malcolm Gladwell.  He describes it as “that one dramatic moment in an epidemic when everything can change all at once.”  For Gladwell, certain large-scale social phenomena – which he terms “epidemics” or “contagions” – take hold through small, incremental changes that tend to happen in a hurry.  

Gladwell asserts that, like medical epidemics, “tipping point” social epidemics obey three laws:

  1. Law of the Few: They are driven by a handful of people

  2. Stickiness Factor: At a certain point a message “sticks” in the memory

  3. Power of Context: Human beings are sensitive to their environment 

Three groups of people facilitate successful social epidemics:

  1. Mavens, who possess the specific information or knowledge

  2. Connectors, who bring people together and disseminate that information

  3. Salesmen, who persuade others to believe the information. 

It’s ironic that Gladwell uses examples of medical epidemics to describe a theory that could be applied to a modality with the curative power of SCT. The increasing and diverse number of patient testimonials online shows how SCT has reached its tipping point.

Roar Africa CEO Deborah Calmeyer used her own stem cells to repair a bone chip on a toe she injured falling down a flight of stairs at a Manhattan restaurant.  After two years, her pain was gone and the cartilage completely healed. 

Grandmother Andrea Coleman of Charlotte, NC used her own stem cells to heal her arthritis pain, pain which she described as “10+.”  Less than two months after the therapy, her pain was at a “2 or a 3.”  And how did she find the clinic?  Her husband did a simple online search.

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High school wrestlers like JD Peralta of small-town Clovis, California used SCT to heal a torn ACL and meniscus. 

South Florida mother Marty Kelly credits SCT with curing her non-verbal autistic son Kenneth.  At eight years old, Kenneth couldn’t talk or reread and was still in diapers. Now, after nine treatments, 17-year-old Kenneth is about to graduate high school.  How did Marty Kelley find out about SCT?  She “stumbled” across a little boy in Orlando who also benefitted from the therapy. 

Finally, Superman actor Dean Cain used SCT to heal chronic pain from a knee injury he suffered playing college football.  He even invited DailyMailTV cameras to record the procedure.  Cain also credits SCT with controlling his father’s Parkinson’s Disease. 

When Superman becomes an SCT connector and salesman, you know you’ve reached the tipping point.

Small Clinics and Large Hospitals Tip the Scales

More and more clinics are offering SCT.  This proliferation is occurring despite the restrictive FDA regulatory regime that dictates stem cells should be “minimally manipulated” and only for approved treatments. Clearly, the medical professionals are not overly concerned with FDA policing and investigation. This is similar to marijuana which, while still illegal under federal law, is legally sold in dispensaries in dozens of states without fear of a crackdown.  

This perception that the FDA has adopted a permissive, laissez-faire stance is telling and evidences another SCT tipping point.

Not only is the number of small clinics increasing, but the availability of SCT in large, mainstream hospitals is further evidence of a tipping point.  As Liz Szabo points out in Kaiser Health News, major hospitals like the Swedish Medical Center – Seattle’s largest non-profit health provider – have begun offering SCT with infomercial-like advertisements.  The Mayo Clinic, Cleveland Clinic and the University of Miami have also entered the field to provide options to patients who have exhausted mainstream remedies. 

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

A serious argument can be made that the SCT tipping point has indeed been reached.  Gladwell’s theory fits the SCT movement well.  Although the SCT movement’s initial push was driven by the few, as Gladwell conceptualized, it is the stories of the many that drive it now. 

Context has also been important. The pain and suffering of countless Americans has provided the context that has forced more clinics and hospitals to provide SCT.  And progress has been quick. Just nine years ago I had to go all the way to China for my SCT.

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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 earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food.

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.

Stem Cells Reduce Pain from Knee Osteoarthritis

By Pat Anson, PNN Editor

A small new study has demonstrated that stem cells collected from a patient’s own bone marrow can significantly reduce pain caused by osteoarthritis of the knee.

In the first clinical trial of its kind in Canada, researchers collected mesenchymal stromal cells (MSCs) from the spines of 12 middle-aged patients with moderate to severe knee osteoarthritis. These “autologous” cells – stem cells derived from a patient’s own fat or bone tissue – were then processed and injected back into the patients’ knees at different doses.

Researchers then followed the patients for the next 12 months, using MRI imaging, biomarkers, molecular fingerprinting and the patient's own assessment of how they felt.

"Our goal was to test for safety as well as to gain a better understanding of MSC dosing, mechanisms of action and donor selection," said lead author Sowmya Viswanathan, PhD, Arthritis Program at the Krembil Research Institute, University Health Network in Toronto.

At the end of the study period, researchers said there were significant improvements in all 12 patients’ pain levels, stiffness and quality of life. The study also showed that the MSCs were safe at all the doses tested and that the higher the dose, the more effective the outcome.

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"We also obtained novel insights into a potential anti-inflammatory mechanism of action of these cells in osteoarthritic knee joints. We noted that donor heterogeneity is an important factor, and our assembled panel of genes helps us identify cells which are potent in osteoarthritis. These are important findings which we hope to translate into a larger, powered clinical trial as part of our next steps," said Viswanathan, who reported the findings in the journal Stem Cells Translational Medicine.

Over 250 million people worldwide suffer from knee osteoarthritis (OA), which causes thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

Knee replacement and arthroscopic knee surgeries are commonly used to treat knee OA, even though many studies show they have limited effectiveness. A 2017 study in The British Medical Journal  of over 7,400 patients who had knee replacement surgery found the procedure often had minimal effects on quality of life and wasn’t worth the cost.

Arthroscopic surgery is less invasive than a total knee replacement, but studies also show it is often not effective. In 2017, an international panel of experts reviewed 25 studies involving nearly two million patients and concluded that arthroscopic surgery does not improve long term pain or function in patients with knee conditions such as osteoarthritis.

Because these conventional treatments often fail, there is growing interest in the use of stem cells to treat knee problems. The FDA, however, takes a dim view of autologous stem cells and released guidance in 2017 that requires the cells to undergo “minimal manipulation.”

The FDA recently sent letters to 20 stem cell manufacturers and clinics warning them they were violating FDA regulations. The agency says the science behind autologous cells is still in its early stages and they have not been proven to be safe and effective.

“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation just because it originated from the person it was given back to,” then FDA commissioner Scott Gottlieb, MD, and Biologics Center Director Peter Marks, MD, said in a statement.

“We’ve seen too many cases of sponsors claiming that cells aren’t subject to FDA regulation just because the cells originated from the same patient to whom the eventual manufactured product is being given. And we’ve seen too many cases of companies making unsubstantiated claims that these treatments prevent, treat, cure or mitigate disease where the products have sometimes led to serious patient harm.”

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.

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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.”

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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.

Experimental Stem Cell Therapy Reverses MS

By Steve Weakley

A small but promising study has shown that an experimental stem cell therapy can dramatically slow the progression of multiple sclerosis. Some MS patients treated with their own stem cells even experienced a reversal of their symptoms that has lasted for years.

MS is a chronic, incurable and progressive disease that attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. The disease affects over 2 million people around the world.

An international team of researchers enrolled 110 patients in the study with relapsing-remitting MS, a version of the disease where symptoms appear for a few days or weeks, followed by periods of remission.

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Half of the patients were treated with standard MS medications as a control group, while the other half went through a four-step experimental procedure.

The experimental group was given chemotherapy to stimulate the production of hematopoietic stem cells that recharge the immune system. Those stem cells were then removed from the patients’ blood and frozen.  After that, a more powerful round of chemotherapy was used to wipe out the patients’ damaged immune systems, and the thawed stem cells were put back into their bodies by transfusion.

Over half of the 55 patients in the control group continued to see their disease progress, while only three patients got worse in the experimental stem cell group. The other 52 had fewer symptoms and a better quality of life. The findings were reported in the journal JAMA.

“It’s the best evidence comparing stem cell transplants to standard therapy,” Harry Atkins, MD, a stem cell scientist at Ottawa Hospital in Canada told Vox . “This is one of the first pieces of proof that, yes, patients who have aggressive MS do better after a transplant than with the standard therapy.”

“The stem cell therapy gets patients off lifelong treatments and gives them results that have never been seen before with this disease,” said lead author Richard Burt, MD, a stem cell researcher and physician at Northwestern University.

One of Burt’s patients who benefited from the stem cell transplant is 28-year old Amanda Loy, who told Vox that prior to treatment she needed a cane to walk and was unable to work.  Within a year of treatment her symptoms had disappeared.

“It sounds so dramatic, but (the treatment) gave me my life back,” said Loy, who now works as a full-time teacher, runs half marathons and plays soccer with her 10-year-old son. She no longer takes MS medication.

Researchers still don’t know if the stem cell therapy will work with other forms of MS or how long the benefits will last. But it’s the first treatment that has shown the potential to actually reverse the disease.

“I do think it’s going to change the natural history of MS,” says Burt. “When you use it in the right group of patients with MS, you get these really gratifying results.”

A recent study by Australian researchers found that another experimental stem cell therapy shows promise in treating patients with progressive multiple MS, the most difficult-to-treat form of the disease.

Scientists at the University of Queensland extracted immune cells from patients who had either primary or secondary progressive MS. The cells – known as T-cells – were then “trained” in a laboratory to target and kill cells infected with the Epstein Barr virus, which has long been associated with MS.

When the altered T-cells were injected back into the bloodstream of 10 patients, seven said their symptoms improved. They had more energy, improved concentration, slept better, and had improved vision and balance. There were no serious side effects.

12 Patients Sickened by Contaminated Stem Cells

By Pat Anson, PNN Editor

At least a dozen patients undergoing stem cell therapy developed bacterial infections after being injected with unapproved stem cell products, according to the Food and Drug Administration. Most of the patients were being treated for chronic back and joint pain.

All 12 patients were hospitalized, but there were no deaths. Seven of the infections were in Texas, four in Florida and one was in Arizona.  CDC investigators found E. coli bacteria in unopened vials at two of the stem cell clinics where the patients were treated.   

All of the patients received stem cells derived from umbilical cords that were initially processed by Genetech, a San Diego stem cell manufacturer.  The stem cells were recalled in October and the FDA sent a warning letter to Genetech last month saying its donor selection, manufacturing and safety standards were deficient.

“In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

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This week the FDA also sent letters to 20 other stem cell providers warning them that the agency would step up its enforcement of guidelines for cell-based regenerative medicine. The FDA has long taken a dim view of newer stem cell therapies that have not undergone clinical testing, but said it would use “enforcement discretion” as long as a new treatment does not pose a significant safety risk.

“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion,” Gottlieb said.  

Gottlieb has previously warned of “unscrupulous actors” in the stem cell industry that deceive patients with “dangerously dubious products.” Critics have complained the agency's "go slow" approach to regnerative medicine has delayed the development of promising new treatments for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.  

New Spinal Discs Grown from Stem Cells

By Steve Weakley

Scientists have moved a step closer to being able to replace degenerated spinal discs with new ones grown in a laboratory from a patient’s own stem cells.

Spinal discs are soft tissues that cushion the vertebrae and enable our backs to conform and perform the tasks of everyday movement. Over time, the discs can wear out and cause the bones of the spine to rub together and pinch nerves. This disc degeneration is one of the leading causes of back pain.

University of Pennsylvania researchers reported in the journal Science Translational Medicine that they have successfully grown and implanted replacement discs made from the stem cells of goats. The cells were grown in a laboratory in a disc shaped form and then implanted into the necks of goats.

After 8 weeks, MRI’s showed that the replacement discs functioned just as well or better than the goats’ original cervical discs. The implanted discs were left in for 20 weeks and became part of the animals’ own tissue.

Researchers told Medical News Today that this was a major step forward from previous experiments in which they implanted discs into rat tails. Goat discs are more comparable to humans in size, structure and function.

"I think it's really exciting that we have come this far, from the rat tail all the way up to human-sized implants," said co-senior author Harvey Smith, MD, a professor of Orthopaedic Surgery at the Hospital of the University of Pennsylvania.  

"Using a true tissue-engineered motion-preserving replacement device is not something we have yet done in orthopaedics. I think it would be a paradigm shift for how we really treat these spinal diseases and how we approach motion sparing reconstruction of joints.”

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Current treatments for degenerative discs include spinal fusion or artificial implants.  Both have limited benefits and usually cannot restore full functionality. Artificial implants also break down and have be replaced.

"The current standard of care does not actually restore the disc, so our hope with this engineered device is to replace it in a biological, functional way and regain full range of motion," said co-senior author Robert Mauck, PhD, a professor for Education and Research in Orthopaedic Surgery.

"This is a major step, to grow such a large disc in the lab, to get it into the disc space, and then to have it to start integrating with the surrounding native tissue. That's very promising."

The researchers say the next step is longer and more extensive tests on goats, before working on a bioengineered human model.  If those tests are successful, they eventually hope to test the implants in human trials.

"We have every reason to be optimistic, and if it works, we can change the way we think about treating some of these disc diseases," said Smith.

New Therapy Helps Improve MS Symptoms

By Pat Anson, PNN Editor

An experimental stem cell therapy developed by Australian researchers is showing promise in treating patients with progressive multiple sclerosis (MS), the most difficult-to-treat form of the autoimmune disease.

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness, difficulty walking, paralysis, loss of vision, fatigue and pain. Most patients go through periods of remission before the condition worsens and turns into secondary progressive MS. In primary progressive MS, the disease steadily gets worse from the start, with no periods of remission.

Scientists at the University of Queensland extracted immune cells from patients who had either primary or secondary progressive MS. The cells – known as T-cells – were then “trained” in a laboratory to target and kill cells infected with the Epstein Barr virus.

When the altered T-cells were injected back into the bloodstream of 10 patients, seven said their symptoms improved. They had more energy, improved concentration, slept better, and had improved vision and balance. There were no serious side effects.

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The Epstein Barr virus (EBV) has long been associated with MS, which is why the researchers targeted it. The virus also causes infectious mononucleosis, a glandular fever known as “mono.”

“Although this was an uncontrolled study, our finding of a substantial relationship between clinical response and EBV reactivity and polyfunctionality of the T-cell product, of which both the patients and examining neurologists were unaware, suggests that the clinical benefit might be due to the T cell therapy,” researchers reported in the journal JCI Insight.

“Our data add to the mounting evidence for a pathogenic role of EBV infection in MS. Because T-cells access all CNS (central nervous system) compartments, T-cell therapy targeting only EBV-infected B cells is a treatment modality that could offer favorable safety and durable efficacy.”

This was a Phase I trial, where the primary goal of researchers is to make sure a treatment is safe to use. More advanced studies with a larger number of patients are needed to see how well altered T-cells actually work on MS.