Who Should I Go See for Stem Cell Therapy?

Right now, the two biggest questions you should be asking yourself if you are contemplating Stem Cell Therapy for any ailment are:

1) How much evidence is there regarding stem cell treatment for my particular condition?

2) Who should I consult with and let treat me with stem cell therapy?

Insulin-secreting NeoIslet made from adult mesenchymal stem cells and pancreatic islet cells. Image courtesy of SymbioCellTech, LLC.

Both these questions should not be taken lightly and require significant understanding of what quality stem cell therapy can and cannot do for any particular condition. Equally as important, what constitutes a stem cell expert today is a particularly scary topic. The short answer to the latter, seems to be just proclaiming yourself an expert is about all it takes. Just in the past 18 months alone, the number of "stem cell clinics" in the United States run by so-called experts has proliferated from a mere handful to over 600. Unfortunately, the vast majority of the practitioners running these highly profitable cash-based clinics have no background or expertise in the field of stem cells and are looking to quickly cash in on a very vulnerable public. In fact, entire networks have now been set up by chiropractors and alternative health practitioners to lure unknowing patients into their clinics to get what they are touting as "Miracle Cures" for a myriad of conditions and charging exorbitant prices.

Never in the more than 30-year history of modern stem cell science or Regenerative Medicine has the chiropractic or alternative medical community been at the forefront of this burgeoning and very complex medical specialty. Hence, this is not where you want to go to get stem cell therapy.  It's only because of media hype and recent lapses in FDA enforcement of the Code of Federal Regulations that these unscrupulous actors have been able to propagate.

“Never in the more than 30-year history of modern stem cell science or Regenerative Medicine has the chiropractic or alternative medical community been at the forefront of this burgeoning and very complex medical specialty.”

Fortunately for the public, the FDA sounded the alarm last month putting the entire stem cell therapy community on notice, including medical doctors and non-MDs alike. The FDA has already begun raiding and shutting down the most dangerous and unethical clinics around the country but eventually hopes to find the resources to police the entire field, which is long overdue. Until that time comes, it has been left to the medical community to remain the watch dogs over this promising field and help ensure that the proper narrative and appropriate stem cell treatments get dispensed in the coming years.  This is no easy task, as the scientific medical community and the alternative non-medical communities are vehemently opposed regarding best practices and the ethicality of treating patients without appropriate data or the FDA's blessing. In a word, it's a cluster.

So, where does this leave you regarding the questions stated above. Who should you talk to and who, if anyone, should you let treat you with stem cells? Unfortunately, without FDA enforcement and appropriate oversight from state medical boards and professional societies, it is a buyer beware environment, something that never should occur in medicine but is now becoming more and more the norm.

“It’s only because of media hype and recent lapses in FDA enforcement of the Code of Federal Regulations that these unscrupulous actors have been able to propagate.”

My advice is to only speak to a medical expert with a true bonafide background in Stem Cell Science and Regenerative Medicine and who has been in the field for at least 10 years or more. These "medical" physicians (MDs & DOs) are out there and can be found in most areas of the country. Unfortunately however, their voices and presence are becoming more and more overshadowed and drowned out by the marketing blitz of chiropractors and alternative charlatans self-proclaiming expertise in the space.

DO NOT LET A CHIROPRACTOR (DC) OR A NATUROPATH (ND) TREAT YOU WITH STEM CELLS!! 

This is a medical therapy that is beyond their scope of practice regardless of what they tell you or advertise in the paper or on the internet.  Any chiropractors or alternative medical provider that is offering stem cell therapy is blatantly and unethically practicing way outside their field and professional training and hopefully soon they all will be shut down by the FDA and individual state medical societies.

As a physician and surgeon with a 23-year background in Stem Cell Science, Cell Therapy & Regenerative Medicine, I am always more than happy to speak to and consult with anyone contemplating stem cell therapy and help guide them to getting the real answers and finding the right practitioner for a particular medical condition.  Ultimately, the answer regarding the appropriate treatment may or may not include stem cell therapy.

SEnd me a message below and we can discuss your issue and the REAL Truth About Stem Cells 

Perspective on Stem Cell Therapies from the New England Journal of Medicine

This editorial comment lays out a perspective reflected in the scientific community at this time regarding stem cell therapy and more importantly the FDA position regarding the proliferation of clinics peddling unproven therapies to a vulnerable public. Although they are not clinicians, the authors, R. Alta Charo, J.D., and Douglas Sipp, B.A., cast valid points in addition to summarizing recent FDA guidance. They conclude that, "Predatory marketing of untested stem cell treatments has exposed patients to unjustifiable risks and has been a blot on the field for more than a decade. The consequences of lax oversight are all too clear. The recent action by the FDA is a promising beginning toward disciplining the field, but it is only a beginning, and much more remains to be done." 

The debate regarding oversight (or lack thereof) both at the federal and state level continues and who and how stem cell therapy should be administered hopefully will be determined and pronounced definitively in 2018. 

Read the full perspective published the NEJM:

http://www.nejm.org/doi/pdf/10.1056/NEJMp1715736

LONG AWAITED FDA GUIDANCE FOR STEM CELLS -"BAD ACTORS" BEWARE IN 2018

Last month the FDA released long awaited guidance regarding stem cell therapy. Essentially, "Guidance" is the law of the land pertaining to drugs, medical devices and more recently, stem cells and biologic materials for patient use. Unfortunately, like many laws, if they are not enforced, then people will break them. Most of us don't want to believe that physicians, chiropractors and naturopathic doctors intentionally break or ignore the law but that is exactly was has been going on for several years now. This explains the explosion of stem cell scams and unqualified drive-thru stem cell clinics offering unproven and even dangerous stem cell therapies. One clinic in Florida blinded 3 patients dispensing an unapproved stem cell therapy. Another group of chiropractors have organized a national network not unlike a Multi-Level Marketing (MLM) scheme they call an "affiliate" program to buy amniotic tissue products in bulk, which are devoid of any living stem cells and market them as a cure all stem cell therapy through these new overnight affliliate "stem cell clinics" thoughout the nation. You've probably seen their ads all over the internet and in newspapers  everywhere.

My hope is that the FDA is not making idle threats this time and is in fact going to crack down on these "BAD ACTORS" who are doing nothing short of a disservice to the entire medical community. Stay tuned for updates on the FDA's actions.

READ RECENT FDA GUIDANCE DOCUMENT: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585403.pdf

FDA WARNS ABOUT STEM CELL THERAPIES

The FDA is the federal watchdog in charge of monitoring the safety of drugs, medical devices and biologic therapies such as stem cells and gene therapy. Unfortunately, not everyone chooses to recognize the FDA's position and authority and hence we have a plethora of unscrupulous actors and clinicians peddling unproven and unapproved "stem cell" therapies. Recently, the FDA posted a warning for consumers on their website regarding the clinical status of stem cell therapies. It's worth a read whether you are contemplating getting stem cell therapy or not. And if you're not, odds are someone you care about is and needs to be informed.

RECENT FDA WARNING:

https://www.fda.gov/forconsumers/consumerupdates/ucm286155.htm

FDA to Crack Down on Unscrupulous Actors

Long overdue FDA oversight is coming. Regenerative Medicine is such a bright and promising field that it will for sure benefit many patients across the breadth of medicine and surgery for decades to come. At this time, more than ever we need rigid guidance and ethical practitioners to advance this exciting field properly and with patient concern and welfare at the forefront. Please visit the link below and read what FDA Commissioner Gottlieb has to say about those that are clearly exploiting the well meaning efforts of the scientific community for greed and gain. 

READ FDA COMMISSIONER GOTTLIEB'S ANNOUNCEMENT:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm

Should You Get Stem Cells

Current State of the (Stem Cell) Union

Many people want to point fingers at who is to blame for the seemingly glacial progress in the field of stem cells and implicate the massive regulatory burden as one of the main impediments. The FDA is very large overburdened government agency who is not necessarily the villain here. They are in charge of protecting public safety. I'm not saying that they are perfect, but if you want somewhere to point the finger,  I would start with the legal system and the litigious environment in the US, which makes organizations such as the FDA extremely paranoid about exposing the public to any heightened risk, even under informed consent.

Regenerative medicine and cell therapy, in particular the use of stem cells of various origin for a multitude of conditions, is extremely complicated field of medicine with a short research history comparatively speaking. Although this newer research in the last couple of decades is based upon a much larger older body of work, there is still much to be tested and many risks to be mitigated.

Probably one of the biggest concerns I have today as a physician-scientist who first entered the field of stem cell biology over 20 years ago is that because of the hype and the public perception of stem cells as a universal panacea, a growing group of individuals, who in my opinion are largely underqualified, are taking this therapy into the clinics with an approach that smacks of reckless abandon. There are now many people receiving stem cells from questionable practitioners at exorbitant prices with almost no real clinical evidence for efficacy. 

We do know based upon the number of people that of been treated that the majority of stem cell treatments that are being administered today are safe, at least for the short term. Hopefully this means that these practitioners are not doing any harm right now.  That said, this is not the way we do things medically in the United States. Like it or not, there are rules to be followed and there's guidance to be headed and many brilliant people have spent their entire careers working diligently and as fast as they can to bring these new therapies to the clinic safely and with the greatest effectiveness.

At this point, to just bypass the last lap of the race if you will is somewhat unethical and could be even considered cheating the system. Unfortunately in this case, "the system" involves vulnerable patients at risk who are in many cases grasping for hope through alternative treatments.

The only people I think who should be administering stem cells now and in the near future are those with a real medical training and scientific backgrounds in the field of cellular biology.  Most of these clinicians should have academic pedigrees in research and the clinical experience to understand more clearly what happens when stem cells are delivered to the body. 

Unfortunately, we have a mixed bag of practitioners out there practicing now, mostly primary care docs and physical medicine & rehab physicians who seem to be just seeking a lucrative outcome by doing procedures on the cash basis that they would not have ordinarily performed had the regulatory hurdles been cleared more efficiently years ago. 

As far as I can tell, very few practitioners administering stem cells today have any scientific background in stem cell research or clinical trials nor do they have the experience of taking cellular therapies through the FDA or working closely with companies in the field.

Hence, I am quite worried about the current state of stem cell therapy in the U.S. as it is now at risk for being forever marred by some early charlatans who have bypassed the legitimate pathway to becoming stem cell experts and clinicians. It's a shame, but if you ask me, I think the stem cell field in America already has one black eye thanks to these individuals and I'm hoping it doesn't get a second one.

My personal scientific and clinical opinion is that stem cell therapy is indeed efficacious, but to what degree at this time is unknown. I am comfortable saying this because I have run an academic stem cell lab, performed my own research including extensive animal studies, and I have been through the FDA more than once having had to demonstrate both safety and efficacy in multiple animal models and in humans. I also know that there are many variables which we do not have worked out yet, the biggest ones are related to which type of stem cells to use, how many to give in terms of dosage, and what frequency in terms of how many injections or how often somebody might need therapy in order to get a satisfactory result.

My advice for the consumer is to do your homework, know everything you can about the therapy you are contemplating receiving and the practitioner who is going to administer it. Make sure the product you are getting is safe and proven to have efficacy for your specific problem. Also, make sure that your practitioner is actually a medical doctor with clinical and scientific training in Cell Therapy and Regenerative Medicine.

If you have any problem finding the answers to these or other questions pertaining to stem cells, just give me, Russ Reiss, a call at Park City Performance Medicine. I am happy to help guide you to finding the right care.

The Truth About Stem Cells

Welcome to the Truth About Stem Cells BLOG. Today the clinical environment surrounding the use of stem cells has all but gone mad. It is like the Wild, Wild West right now and there are many myths out there that need to be busted. With this blog we will tell it like it is, including the good, the bad, and the ugly.