More Risks on Stem Cell Injections

Many patients and their doctors are hoping against all hope that these stem cell injections will work. I too hope and pray these stem cell injections will work if injected into the meibomian gland. However, it has never been tried and there are still big concerns.

While we proceed with submitting an IRB for our research for Stem Cell Injections into Meibomian Glands (STIM) and look for funding (in efforts to avoid charging patients) it is important for all patients to know the risks before they agree to have any stem cell injection.

In the meantime, if anyone knows of a generous donor who wants to help us get to the bottom or whether stem cells work or not for Meibomian Gland Disease, please let us know. Our alternative is to charge patients per treatment likely around $5000, which we prefer not to do. Currently, our protocol is to treat only one eye’s upper and lower lid and use the non-treated eye’s lids as controls.

Still if I had a loss of glands and chronic eye pain, I would pay this to see if it works, knowing the risks we currently know and knowing that all the risks may not even be known by researchers. I know that once the glands are scarred, there is less of a chance even STIM will work so I would want to be injected while I have even a stub of Meibomian Gland visible on Meibography. But we do not know if STIM will not work on fully scarred glands. The only thing we do know is that if one has fully scarred glands, the cornea will suffer from chronic signs of dryness and scar will eventually develop on the cornea which can decrease vision in some patients, lead to chronic eye pain in many, and loss of vision in others as well.

Please let me know if you want to be put on our list of patients to contact regarding STIM. Patients from around the country are contacting me to ask about this procedure. Please encourage your friends and family to donate to Visionary Eye Foundation via Paypal. It is tax deductible. I did a medical/surgical mission trip to Bolivia with their help. They do surgical missions to help blind children and adults yearly, so it is worthy project which I also donate to every year. They will likely be able to help us with a grant for this project.

The below articles are a must read for anyone considering any type of Stem Cell injection. Stem Cell Injections is the wild frontier of medicine. My advisor Dr. Judah Folkman at Harvard often said that his work on angiogenesis was like the wild frontier of medicine. He was laughed out of many national meetings in his attempt to show that angiogenesis was the basis for cancer growth and metastasis. The biggest issue with Stem Cell injections is the lack of definitive proof it works and the fact that most patients have to pay out of pocket for this still not fully proven technology. Still there are many patients that tell me they were able to avoid surgery after a stem cell injection. Is this true? Is it a placebo effect? Where is the cellular proof? With Meibomian Gland Stem Cell Injections (MeGSCI), we will have proof of “yes it works” or “no it does not” with meibography photos pre and post injection.

Sandra Lora Cremers, MD, FACS

Stem Cell Soup – The Importance of Knowing What Is In It

“I don’t even know what’s in the soup,” was the shocking quote from the founder of a chain of clinics highlighted in a recent Associated Press article about the increasing prevalence of clinics offering unproven stem cell therapies. The “soup” referred to the mixture of cells and fluid he extracted from a patient’s fat for re-injection into the same patient’s knees, one of many “stem cell” procedures being tried for more than 20 diseases and conditions.

Clinics that offer such “soup” and other so-called “stem cell treatments” that have not been rigorously tested have been the focus of considerable attention lately. In recent months, two highly-publicized scientific reports document the rapid, world-wide, growth of such clinics. In the U.S., the Food and Drug Administration (FDA) released draft guidance documents to clarify regulatory expectations, including that cells harvested from fat and introduced into a different part of the body are subject to FDA oversight, and held a public hearing in September to hear comments on the proposed guidance.

The FDA hearing was a chance for the ISSCR and others to reiterate the importance of regulating stem cell treatments, including those using one’s own cells. The reasons why unproven treatments are still available for sale is nuanced. However, the widespread scientific concerns that these unproven treatments continue to proliferate in the absence of rigorous scientific support are not.

A fundamental concern is the lack of characterization of these treatments. This begins with the use of the term “stem cells.” Cells should only be defined as stem cells if rigorous criteria are met: a demonstrated capacity to self-renew (to give rise to more stem cells) and to give rise to specialized cell types such as blood cells or muscle cells.

This issue is particularly concerning as it relates to the use of the term “mesenchymal stem cells” (MSCs) to describe the desired cells extracted from a patient’s fat. Not only is there considerable skepticism in the field about whether these MSCs manifest so-called “stemness” but there is no way to know how many MSCs are even in the “soup” extracted from fat.

The identification of MSCs requires the cells to be grown in a laboratory for days under special conditions or the use of specific MSC markers to identify and isolate them, although the reliability of these markers is still being debated. What this means for the patient is that the same-day treatments with the “soup” are likely to be a mixture of fat and other specialized cell types with no reliable information on whether MSCs are present and if so, how many are present.

Additionally, stem cells from different tissues have different functions and there is still debate about whether MSCs from all tissue sources (fat versus bone marrow, for example) have the same properties. Furthermore, research on other adult stem cells has shown that stem cells can decline in frequency and function as they age. How these and other biological factors might influence the effects of MSCs is unknown.

The lack of rigorous evaluation of the “soup” and similar “treatments” raises many questions that can only be addressed by rigorous scientific study and clinical trials. Authentic patient testimonials can highlight individual results, but they fail to capture all patients’ experiences, and thus fail to give a complete assessment of the therapy. This commercial marketing strategy is reminiscent of the infomercials where an enthusiastic user excitedly promotes the product’s benefits while the small print at the bottom of the screen reads, “results may not be typical.”

The increase of purported stem cell treatments with little to no evidence of clinical utility, and in some cases a disregard of the known cell- or tissue- biology, has led many scientific organizations to take action. The ISSCR has released updated professional guidelines for its members and the stem cell community that contain explicit condemnation of “…unproven stem cell-based interventions outside of the context of clinical research…” Other organizations, such as the American Thoracic Society, the Australasian College of Sports Physicians, among other groups, have released cautionary statements that speak to specific unproven treatments within their specialty areas.

The ISSCR has also developed an informational website, a CloserLookatStemCells.org, designed to help people understand the basics of stem cell science and more. It provides facts about the research and probative questions to consider when evaluating potential clinical trials or stem cell interventions.

Stem cells offer the potential to treat many intractable disease and injuries but there is still a lot to learn about their therapeutic potential. The clear path forward for this relies upon rigorous testing of the safety and effectiveness of the potential treatment in clinical trials and the sharing of experimental and clinical data to ensure that clinical applications are evidence-based.

2. This article also points out the experimental nature of stem cell injections.

https://www.pressreader.com/usa/los-angeles-times/20170402/281973197498274

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Stem cell therapy costs $15,000 — and may not work

But on a recent Wednesday morning, the Durgelohs were at the DoubleTree hotel in Del Mar, where their bill was paid by StemGenex. Durgeloh was still wearing a bandage on his midriff, where a StemGenex doctor had performed liposuction to obtain stem cells that subsequently were reinjected into his body, ostensibly to regenerate his damaged bones and tissues. They were preparing to fly home, infused with the hope communicated by the clinic staff, who “seemed very optimistic,” Durgeloh told me.

A lawsuit in San Diego federal court suggests that StemGenex may have given the Durgelohs nothing but hope. Three StemGenex patients — two with diabetes and one with lupus — say they were misled by the medical group’s marketing pitch to pay $14,900 each in 2015 and 2016 for therapies that have had no effect.

The lawsuit, which seeks class-action status, claims that StemGenex has made its money by “targeting the ill and the elderly” with “false, fabricated and purposefully misleading” claims about patient satisfaction. Selena Moorer, a lupus patient from Florida, and her two co-plaintiffs say StemGenex has “no reasonable basis for its marketing claim that the Stem Cell Treatments were effective to treat diseases as advertised.” The lawsuit names StemGenex, Alexander and Andre Lallande, the group’s chief medical officer, as defendants. The company denies the claims made in the lawsuit.

Durgeloh’s treatment was typical of the procedures offered as stem cell therapy. He says he received injections directly into his hips, his ailing knees and his back, with whatever was left over suffused into his body via an IV drip.

What’s most important to know is that there’s no accepted scientific evidence that treatments using cells from adipose fat tissue layers work.

But as we reported last year, many clinics offering the treatments capitalize on the public’s impression that stem cells have become some sort of medical miracle.

Dr. Mehmet Oz warned his vast television audience about this misconception in February, when he aired a lengthy undercover investigation of stem cell clinics and called for government regulation. StemGenex wasn’t mentioned in the piece.

StemGenex, in its reply to the Moorer lawsuit, asserts that the plaintiffs “cannot prove” that its “representations regarding the efficacy of its stem cell treatments are actually false.” The plaintiffs, it continues, “do not cite to a single scientific study that disproves [StemGenex’s] advertised claims.”

StemGenex may not have to prove that in a court of law, but that’s not the way federal regulation works. At nearly $15,000 a pop, the companies should have to show that a treatment works.

The FDA has been grappling with this very point in pondering how to regulate the burgeoning industry. There are more than 500 clinics offering stem cell treatments in the U.S., according to a survey released last year by stem cell scientist Paul Knoepfler of UC Davis and bioethicist Leigh Turner of the University of Minnesota.

Right now, there’s no consensus how these clinics should be regulated.

In 2015, UC San Diego researchers described stem cell treatment as “medicine’s Wild West.” As Hermes Taylor-Weiner and Joshua Graff Zivin observed, “Because FDA guidelines are ambiguous, stem-cell clinics have in effect been operating without regulation.”

The proliferation of the clinics has forced the FDA to take a closer look.

The government agency maintains that using stem cells extracted from a patient’s fat requires licensing as a drug, device or biological product, which means the clinics have to demonstrate that the products are safe and effective, possibly via a clinical trial.

The clinics obviously disagree. Steven Brody, chief scientific officer of StemGenex, testified at an FDA hearing in September that if the FDA took a hands-off approach, “this would help our patients have access to stem cell therapies.”

In March, the New England Journal of Medicine reported the “devastating outcome” for three elderly women injected with fatderived stem cells directly into their eyeballs by a clinic in Florida as a treatment for macular degeneration. The treatment left the patients totally or mostly blind.

Stem cell clinics typically are cagey about what patients should expect. They “neither claim their treatments are effective nor explicitly state that they’re unfounded,” Taylor-Weiner and Zivin observed. “Their language is intentionally imprecise and exploits the vulnerability of patients with debilitating diseases.”

Indeed, a disclaimer on the StemGenex home page states, “Stem cell therapy is not FDA approved,” and, “StemGenex Medical Group and affiliates do not claim that treatment using autologous stem cells are a cure for any condition, disease, or injury.”

That’s a striking admission for a treatment costing nearly $15,000 out of pocket and might help explain why health insurers shun the treatments.

The emotional video testimonials from patients posted on the StemGenex website carry disclaimers that the results experienced by those patients “may not be typical or expected …. You should not expect to experience these results.”

When I asked Jamie Schubert, a StemGenex spokeswoman, to point me to a scientific study or any other evidence that its treatments work, she replied that “anecdotal feedback” from patients indicates that “their symptoms have improved and their quality of life has increased.”

There are other red flags. One of the medical group’s physicians, plastic surgeon Scott Sessions, was placed on three years’ probation by the California Medical Board in February. He was accused of negligence related to cosmetic surgery and other procedures he performed on two patients at an unrelated facility in 2011 and 2013.

Schubert told me Wednesday that “Dr. Sessions has informed us that he is in compliance with all requirements of the probationary terms of the medical board.” But the very next day, his name, photograph and bio had disappeared from the StemGenex website. Sessions didn’t respond to a request for comment.

The same thing happened with the logo of the American Board of Surgery, which had been prominently displayed on the StemGenex site, implying the company had the certification board’s seal of approval. After I mentioned to Schubert that a board official told me that display was “a complete misuse of our logo,” it vanished. Schubert called it “an error.”

People’s health needs are not suitable for unregulated Wild West experimentation, and anecdotal feedback isn’t proof that “cutting edge” treatments are safe and effective.

The course couldn’t be clearer for the FDA and state medical regulators across the country: If these stem cell clinics are endangering their customers’ health and draining their pocketbooks for quack remedies, shut them down.

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Los Angeles Times

2 Apr 2017