Stem Cell Injections?

Discussion in 'Men's Health Forum' started by Demondosage, Feb 20, 2019.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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.

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  2. T-Bagger

    T-Bagger Member

    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 likes this.
  3. NorthMich

    NorthMich Member Supporter

    Makes one wonder if it even works?
    Michael Scally MD and T-Bagger like this.
  4. Demondosage

    Demondosage Member

    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
  5. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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 and NorthMich like this.
  7. Demondosage

    Demondosage Member

    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?
  8. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  9. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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.
    Millard Baker, T-Bagger and NorthMich like this.