[Scam] Stem Cell Injections?

[Michael Scally MD]

Scams ... Crap ...



Inside Mark Berman’s clinic in Rancho Mirage, California, is a sign he’s obliged by law to post. It reads “Not FDA Approved.”

Patients who come here to the California Stem Cell Treatment Center can get treatments for ailments ranging from sports injuries to muscular dystrophy. For upward of $5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, process it, and inject it back into them.

This is called “fat-derived stem cell therapy”; the premise is that the stem cells in your fat can jump-start the healing process. “The stem cells could be good for repairing everything from Alzheimer’s to paralysis to neurodegenerative conditions,” says Berman. “These cells are miraculous for helping heal. We don’t have a choice. We have to use them.”

The problem is there’s not much evidence to back up the claims Berman is making. And it’s not just him — there are more than 100 clinicians in the Cell Surgical Network, a group he co-founded in 2010 to promote the same kind of adult stem cell regenerative medicine he practices. According to a 2017 report by three Food and Drug Administration scientists in the New England Journal of Medicine looking at the benefits and risks of this kind of stem cell therapy, “This lack of evidence is worrisome.”

Fat-derived stem cells “may have a positive effect,” says Brad Olwin, a professor of molecular, cellular and developmental biology at the University of Colorado Boulder with more than 30 years of experience working with stem cells. “They may be beneficial; it’s clearly a possibility. The problem is the research hasn’t been done.”

So little evidence exists, in fact, that the Department of Justice, on behalf of the FDA, is suingBerman’s clinic as well as a clinic in Florida for experimenting on patients with misleading products. The complaint was filed in May 2018 and the investigation is ongoing, according to the DOJ.

Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize regulation in the field. But despite these efforts to streamline a path to legitimacy for stem cell clinics, unregulated medical procedures persist, at times leading to patient harm.

 

[T-Bagger]

Scams ... Crap ...



Inside Mark Berman’s clinic in Rancho Mirage, California, is a sign he’s obliged by law to post. It reads “Not FDA Approved.”

Patients who come here to the California Stem Cell Treatment Center can get treatments for ailments ranging from sports injuries to muscular dystrophy. For upward of $5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, process it, and inject it back into them.

This is called “fat-derived stem cell therapy”; the premise is that the stem cells in your fat can jump-start the healing process. “The stem cells could be good for repairing everything from Alzheimer’s to paralysis to neurodegenerative conditions,” says Berman. “These cells are miraculous for helping heal. We don’t have a choice. We have to use them.”

The problem is there’s not much evidence to back up the claims Berman is making. And it’s not just him — there are more than 100 clinicians in the Cell Surgical Network, a group he co-founded in 2010 to promote the same kind of adult stem cell regenerative medicine he practices. According to a 2017 report by three Food and Drug Administration scientists in the New England Journal of Medicine looking at the benefits and risks of this kind of stem cell therapy, “This lack of evidence is worrisome.”

Fat-derived stem cells “may have a positive effect,” says Brad Olwin, a professor of molecular, cellular and developmental biology at the University of Colorado Boulder with more than 30 years of experience working with stem cells. “They may be beneficial; it’s clearly a possibility. The problem is the research hasn’t been done.”

So little evidence exists, in fact, that the Department of Justice, on behalf of the FDA, is suingBerman’s clinic as well as a clinic in Florida for experimenting on patients with misleading products. The complaint was filed in May 2018 and the investigation is ongoing, according to the DOJ.

Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize regulation in the field. But despite these efforts to streamline a path to legitimacy for stem cell clinics, unregulated medical procedures persist, at times leading to patient harm.

My friend with MS did it based off of a few testimonials he saw. The success rates are few and far between, if any.

 

[NorthMich]

Makes one wonder if it even works?

 

[Demondosage]

$550
$1000
$2000
$10-15k
$35k

What's up with the differences in cost?

Ok, went for a visit with a different doc to get another look at it. For elbow region it's about 5k, it depends on location and also region you're in.

In new York PRP shots cost out the ass, in southeast area I pay 500$ a shot. I've done it twice now and honestly I'm not even sure it does much at this point. I may have the same success rate just taking time off.

So the tricep tendon near the elbow is pretty much fucked. The doctor said they can do surgery to detach it, reattach it and let it heal in a more positive environment, or I can take time off and see what it does on its own.

Nobody is cutting my tendon, I'll take my chances and heal it

 

[Michael Scally MD]

Stem Cell Twitter ...

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About Us - The Niche

 

[Michael Scally MD]

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something!

According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit.

Further, they are both filing motions asking for summary judgment and asked for more pages to make their respective arguments.

Things are moving fast now. Everything is due tomorrow to the court.

A decision could be announced within a matter of a few weeks. This is much sooner than most people thought since otherwise the trial start date was in May.

I bet that USRM will ask for dismissal of the case and the feds will ask for summary judgment in favor of a permanent injunction.

What will actually happen?

I believe USRM is almost certainly going to lose.

Even with a likely appeal coming after that summary judgment, I predict USRM will be subject to a permanent injunction before the end of this year. No more fat stem cell injections. In fact, if as expected the government wins this case in a few weeks, USRM’s clinic biz could be nearly immediately subject to the injunction so it could be done as a stem cell clinic within a month.

That would be a good thing given the risks to patients and other issues. Recall that USRM is a publicly-traded company that has been linked to the blinding of several patients, and is facing other problems such as an SEC investigation.

What if USRM unexpectedly wins this particular court case? Stranger things have happened in the stem cell world, but even if USRM pulls a rabbit out of a hat on this case, I’d imagine FDA would appeal and probably win there. I’m no lawyer though so what do I know? Maybe a year from now USRM will still be selling fat stem cells for a host of health conditions and I’ll just be scratching my head.

 

[Demondosage]

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something!

According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit.

Further, they are both filing motions asking for summary judgment and asked for more pages to make their respective arguments.

Things are moving fast now. Everything is due tomorrow to the court.

A decision could be announced within a matter of a few weeks. This is much sooner than most people thought since otherwise the trial start date was in May.

I bet that USRM will ask for dismissal of the case and the feds will ask for summary judgment in favor of a permanent injunction.

What will actually happen?

I believe USRM is almost certainly going to lose.

Even with a likely appeal coming after that summary judgment, I predict USRM will be subject to a permanent injunction before the end of this year. No more fat stem cell injections. In fact, if as expected the government wins this case in a few weeks, USRM’s clinic biz could be nearly immediately subject to the injunction so it could be done as a stem cell clinic within a month.

That would be a good thing given the risks to patients and other issues. Recall that USRM is a publicly-traded company that has been linked to the blinding of several patients, and is facing other problems such as an SEC investigation.

What if USRM unexpectedly wins this particular court case? Stranger things have happened in the stem cell world, but even if USRM pulls a rabbit out of a hat on this case, I’d imagine FDA would appeal and probably win there. I’m no lawyer though so what do I know? Maybe a year from now USRM will still be selling fat stem cells for a host of health conditions and I’ll just be scratching my head.

Curious if any of this will effect marrow transplants. If Im not mistaken arent the stem cells from marrow different than these fat cell injects?

 

[Michael Scally MD]

Curious if any of this will effect marrow transplants. If Im not mistaken arent the stem cells from marrow different than these fat cell injects?

Correct.

 

[Michael Scally MD]

The Birth-Tissue Profiteers
How well-meaning donations end up fuelling an unproven, virtually unregulated two-billion-dollar stem-cell industry.
The Birth-Tissue Profiteers

For more than half a century, the regenerative possibilities of stem cells—which the body stores to repair damaged tissue and organs and restore blood supply—have tantalized the medical community. Bone-marrow transplants for cancer patients, which rely on blood stem cells, fulfill this potential. But alongside legitimate, scientifically proven treatments, an industry has sprung up in which specialized clinics offer miracle remedies from poorly understood stem-cell products.

These clinics are multiplying in the United States. According to a tally by Leigh Turner, an associate professor of bioethics at the University of Minnesota, there were twelve such clinics advertising to consumers in 2009; in 2017, there were more than seven hundred. Unproven cellular therapies are a two-billion-dollar global business, according to a recent paper co-authored by Massimo Dominici, the lead investigator at the cellular therapy lab at the University of Modena and Reggio Emilia, in Italy.

This burgeoning business is largely unregulated. Technically, manufacturers are required to submit stem-cell therapies for review as a drug, and to provide evidence of their safety and efficacy, but the U.S. Food and Drug Administration hasn’t enforced the rule consistently. The former F.D.A. commissioner Scott Gottlieb acknowledged in an interview that the agency’s laissez-faire attitude has made it easier for stem-cell clinics to proliferate.

“This is an example where the F.D.A., for a long period of time, took enforcement discretion, then the field grew,” he said. “Then it becomes hard to step in and actually apply the regulation.”

Many clinics offer stem cells taken from a patient’s own bone marrow or fat. But they’re being challenged by a newer technology: amniotic stem cells.

One appeal of amniotic stem-cell treatments is convenience. They don’t require patients to undergo liposuction or bone-marrow extraction; instead, manufacturers harvest the cells from tissues donated by women who have recently given birth, and the cells are then frozen and shipped to clinics.

There is no special training needed to administer amniotic treatments, either—a nurse practitioner on staff can give injections—so chiropractors, beauticians, and sports-medicine doctors can enter the field with relative ease.

A procedure such as an injection into a joint might take about ten minutes and cost between five and ten thousand dollars. For systemic diseases, such as lupus, some clinics also administer the cells intravenously, which can cost more than ten thousand dollars per session.

Because amniotic-stem-cell treatments don’t undergo the clinical trials required for F.D.A. approval, there’s little data or research on them. Their efficacy is highly questionable and, in one case where bacteria contaminated the supply, the lack of accountability in the industry has led to serious infections for a dozen patients.

An investigation by ProPublica and The New Yorker found disgraced doctors who were recast as salespeople, manufacturers that cloaked themselves in pseudo-science and had few scientists on staff, and clinics that offer to treat conditions like multiple sclerosis or kidney disease without specialized training.

Unscientific methods, deceptive marketing, price gouging, and disregard for patients’ well-being were rampant across the amniotic-stem-cell-therapy industry.

 

[Michael Scally MD]

A judicial ruling this month that will stop questionable stem-cell treatments at a clinic in Florida is widely seen as a warning to a flourishing industry that has attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures.

But with little regulatory oversight for the hundreds of clinics operating these lucrative businesses across the country, it’s too soon to tell how far the impact might reach.

The decision, by a federal court on June 3, empowered the Food and Drug Administration to stop U.S. Stem Cell, a private clinic in Sunrise, Fla., from injecting patients with an extract made from their own liposuctioned belly fat. https://www.courtlistener.com/recap/gov.uscourts.flsd.527228/gov.uscourts.flsd.527228.73.0.pdf

The clinic had claimed that the extract contained stem cells with healing and regenerative powers that could treat a range of illness and injuries, from back problems to Parkinson’s disease, arthritis, and heart and lung diseases.

In granting the F.D.A.’s request for an injunction against the clinic, Judge Ursula Ungaro agreed with the agency that extracting stem cells from fat requires so much processing that it essentially transforms them into a drug. That alteration firmly places such treatments under the jurisdiction of the F.D.A., which has the authority to regulate drugs.

 

[T-Bagger]

A judicial ruling this month that will stop questionable stem-cell treatments at a clinic in Florida is widely seen as a warning to a flourishing industry that has attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures.

But with little regulatory oversight for the hundreds of clinics operating these lucrative businesses across the country, it’s too soon to tell how far the impact might reach.

The decision, by a federal court on June 3, empowered the Food and Drug Administration to stop U.S. Stem Cell, a private clinic in Sunrise, Fla., from injecting patients with an extract made from their own liposuctioned belly fat. https://www.courtlistener.com/recap/gov.uscourts.flsd.527228/gov.uscourts.flsd.527228.73.0.pdf

The clinic had claimed that the extract contained stem cells with healing and regenerative powers that could treat a range of illness and injuries, from back problems to Parkinson’s disease, arthritis, and heart and lung diseases.

In granting the F.D.A.’s request for an injunction against the clinic, Judge Ursula Ungaro agreed with the agency that extracting stem cells from fat requires so much processing that it essentially transforms them into a drug. That alteration firmly places such treatments under the jurisdiction of the F.D.A., which has the authority to regulate drugs.

That’s why US companies have moved out of the US and moved to Costa Rica where they can continue to do this crap.

 

[Michael Scally MD]

[OA] How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments

Providers capitalize on patient testimonials to market unproven stem cell treatments (SCTs).

We evaluated 159 YouTube videos and found patients discussed health improvements (91.2%), praised providers (53.5%), and recommended SCTs (28.9%).

In over a third of the videos, providers posed questions to patients, thereby directing narratives and making them a powerful marketing tool.

Hawke B, Przybylo AR, Paciulli D, Caulfield T, Zarzeczny A, Master Z. How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments. Stem Cell Reports 2019;12:1186-9. Redirecting

 

[Michael Scally MD]

 

[LeoTC]

Yea, see this is what I'm afraid of. I know I'm probably looking at 10-15k for one inject to the elbow area and it's not proven enough for me to feel comfortable spending that kind of money on a MAYBE.

I think what I'm going to do is continue with the PRP shot series when needed. I had my 2nd PRP shot a few days ago and I'm basically treating the elbow as if I had surgery. I've tried training through it for several months after the first PRP inject, but I think it's something I'm just going to have to train around.

The MRI shows the damage but it's difficult to say how much damage there really is. The orthopedic docs can't really say "20% damage, 35% damage, etc"

I don't even know if PRP works but I've heard it helps dumb down the pain each time and promotes faster healing. I'm at the orthopedic doc now, I'll get a price on stem cells and report back, the hospital here just got approved to do it a month ago

Look into having the procedure done in Cuba. They tend to offer some of the cheapest procedures, while maintaining a high standard of care.

A lot of misconceptions about Cuba, but they have some world class providers.

 

[Demondosage]

Look into having the procedure done in Cuba. They tend to offer some of the cheapest procedures, while maintaining a high standard of care.

A lot of misconceptions about Cuba, but they have some world class providers.

Thank you, as of tonight I may need a surgery for a detached tricep tendon. It felt like it was healing but I took mg son rollerskating and I fell and nailed my elbow hard as fuck. It's swollen to hell and back and I'm wondering if the tendon didn't come detached. I'm going back to ortho doc tomm, I'm at the point where I'm abt to just have surgery done and get area cleaned out, bone spur removed, and lay off while it heals in the right environment. Fuck getting older!!!

 

[Demondosage]

Motherfucking thing!!! I fell and felt a cpl snaps and now I'm swollen as fuck!!! What scares me is it's not really the elbow, it's the area just above it where the fucking damage was to begin with!!!

 

[Michael Scally MD]

U.S. Stem Cell must stop injecting fat extracts into patients, an unproven treatment that federal officials say blinded some patients.

A federal judge on Tuesday issued a permanent injunction against U.S. Stem Cell, a Sunrise, Fla., clinic accused of blinding three patients by injecting a fat extract into their eyes.

The company is just one of hundreds of businesses that have sprung up around the country offering to treat a wide array of illnesses with products they say contain stem cells that have healing and regenerative properties. Medical experts say there is no proof that such treatments work.

Many of those clinics, like U.S. Stem Cell, use extracts from fat. Others use patients’ own bone marrow, and some use cord blood or other birth tissue like amniotic membranes.

Although the injunction applies only to one company, it is widely seen as a warning to others that perform similar procedures.

https://27funs395cqh24ygs02lso4j-wpengine.netdna-ssl.com/wp-content/uploads/2019/06/936e5ebb-7674-4046-a898-a4528b6ea361.pdf (The injunction) stated that U.S. Stem Cell’s fat extracts are legally a drug, subject to regulation by the Food and Drug Administration. The clinic can no longer produce or market the extracts unless it meets the F.D.A.’s standards for good manufacturing practice.

U. S. Stem Cell had claimed that it could treat neurological, autoimmune, orthopedic and degenerative diseases, including Parkinson’s, amyotrophic lateral sclerosis (also known as A.L.S. or Lou Gehrig’s disease), lung and heart disease, back problems, arthritis and other ailments. The clinic had been performing liposuction on patients to suck out belly fat, then processing the fat to extract what it said were stem cells and then injecting the extract back into patients.

The company’s chief scientific officer, Kristin C. Comella, had argued that the extracts contained patients’ own cells, and therefore were not a drug and were exempt from regulation by the F.D.A.

…

The F.D.A. said the injunction “sends a strong message to others” who manufacture unapproved stem cell products.

In a statement, Dr. Norman E. (Ned) Sharpless, the acting F.D.A. commissioner, and Dr. Peter Marks, director of the agency’s biologics center, said: “We know that there are clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The F.D.A. has consistently stated that this is not true, and the result of this case proves that.”

The statement also said that the companies have been taking advantage of patients, “many in vulnerable positions with chronic or terminal diseases.”


Legal experts say the judge’s ruling suggests that the F.D.A. is also likely to win an injunction that it has requested against another stem-cell business, Cell Surgical Network, a California company with dozens of affiliates around the country.

 

[Michael Scally MD]

On June 24, 2019, a class action was certified against a San Diego stem cell clinic, StemGenex, Inc., its owners and related entities. The lawsuit claims fraud, false advertising and violations of consumer law relating to stem cell treatments aggressively marketed to people with a variety of diseases and medical conditions. Moorer v. StemGenex Medical Group Inc., et al., United States District Court for the Southern District of California, Case No.: 16-cv-2816-AJB-NLS, Hon. Anthony J. Battaglia.

The case centers around patient satisfaction ratings that were published by the company on its website and in marketing materials showing 100% of prior patients were “satisfied” with the treatments. The lawsuit claims that prospective patients purchased the treatments in reliance upon those figures, which were false.

StemGenex argued that their ads were simply an accurate reflection of next-day tallies of how people felt about the service and the company after they had just had the treatment. But it was revealed during the lawsuit that the clinic had in fact received complaints from unsatisfied patients, for whom the stem cell treatments had little or no effect. Often, patients were told that the best remedy would be to return for a second, expensive treatment.

The class is comprised of hundreds of customers throughout the United States, all of whom had the same type of treatment, a stem cell process which used each person’s own belly fat, and all of whom paid Defendants the same amount – $14,900 per treatment.

 

[T-Bagger]

@Michael Scally MD your thoughts on this?

First Paralyzed Person Treated With Stem Cells Regained His Upper Body Movement

 

[Michael Scally MD]

@Michael Scally MD your thoughts on this?

First Paralyzed Person Treated With Stem Cells Regained His Upper Body Movement

Highly doubtful as it has not been replicated ...

Asterias has merged with BioTime https://www.biotimeinc.com/

If you read the fine print at the Asterias website, one question that pops out is who exactly is a candidate for their study. The answer? People with injuries that are between two and six weeks old. This is the range they’re calling “sub-acute,” and the reason for that particular restriction is that when those scientists back in California tried putting their cells into rats with longer-term injuries (usually called “chronic SCI”), the rats didn’t get better. Some of them actually got worse.

This particular wrapper cell replacement project, then, is only aimed at people less than two months post-injury. So when your friends link you to the next story of how Asterias is on the brink of solving spinal cord injury with stem cells, you can tell them that this will, maybe someday, be a therapy for those unlucky people whose injuries are still in the future. May it be so. Research Matters: Stem Cell Reality Check - New Mobility