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\u201cPeople often ask if stem cells work. Of course, they work. We are all walking stem cell products – the sperm, and the egg,\u201d the revered James Willerson, MD, Ph.D. said in a talk in 2011.[1]<\/a><\/sup><\/p>\nThe Tide Pod Teenage Eating Fad, Gronk, and Reverse Psychology In 2018, the Teenagers Eating Tide Pods Fad<\/a> resulted in 10 deaths and 37 reported poison cases.<\/p>\n Proctor and Gamble, Tide\u2019s manufacturer, went on the offensive to protect kids from poisoning themselves.<\/p>\n They even hired NFL superstar Rob Gronkowski to come from behind in the clutch as he had done to win four Super Bowls with Tom Brady. However, Gronk’s YouTube Tide Pod admonishment<\/a>\u00a0resulted in more teens taking the challenge.<\/p>\n Contamination, the FDA, and Reverse Psychology One day later, the agency issued a press release<\/a> informing manufacturers, providers, and the public of Liveyon\u2019s issues and the broader scope of their concerns. The other recipients were RichSource Stem Cells, Inc.<\/a>, Chara Biologics, Inc.<\/a>, and R3 Stem Cell, LLC<\/a>. In total, FDA issued \u00a0350 warning letters<\/a> to manufacturers, healthcare providers, and clinics.<\/p>\n The result: Increasingly, chiropractors, dentists, naturopaths, integrative doctors, infusion clinics, orthopedists, and so on treat patients with unapproved, potentially contaminated, dead stem cells.<\/p>\n Who Killed the Stem Cells Risk Appetite A 2016 study identified 351 businesses promoting stem cell treatments. Five years later, the same author, estimated more than four times as many businesses (1,480) sell stem cell treatments, approximately half of which (781) promote umbilical, amniotic, or exosome treatments. [6]<\/a><\/sup><\/p>\n More on risk-taking later. First, what are \u201cperinatal stem cells\u201d?<\/p>\n Perinatal Stem Cells That sounds good on the surface, but as explained in The Cell Source Debate<\/a>, mesenchymal stem cells (MSCs) are rare in birth tissues and fluid. There is more to that part of the story to follow.<\/p>\n Exosomes All cells with DNA \u2013 cancer, tissue, immune, blood cells, etc. secrete exosomes.<\/p>\n Mesenchymal stem cells (MSCs) release them too. Despite no reported side-by-side in-human studies, this mechanism has led some researchers and amateur stemcellologists to believe they are more effective than MSCs or ADRCs.<\/p>\n And where a therapeutic dose of MSCs might be 40 -100 million cells, exosome manufacturers claim their vials contain hundreds of millions. A South Florida \u201cstem cell physician\u201d touts one billion exosome vials – without evidence that more is better, much less sterile or safe.<\/p>\n Lab techs must multiply the MSCs or exosomes in culture to obtain a relevant dose.\u00a0 However, maintaining current Good Manufacturing Practices (cGMP) requires adherence to rigorous standards.<\/p>\n Whodunnit?<\/strong><\/p>\n Wondery’s ten-episode whodunnit, Bad Batch<\/a>, illustrates the significant safety risks Liveyon\u2019s slick marketing and non-sterile lab practices delivered to patients. In sum, over 200 patients reported severe adverse events.<\/p>\n Additionally, the CDC published its lab findings in the Journal of the American Medical Association (JAMA) in 2021.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.19.4″ background_color=”#f0f2e5″ custom_margin=”||||false|false” custom_padding=”25px|25px|25px|25px|false|false” global_colors_info=”{}”]<\/p>\n Key Points<\/span> Findings In this case series<\/strong>, 20 patients in 8 states, developed bacterial infections after receiving unapproved products marketed as treatment for conditions including chronic pain and degenerative joint conditions. This national investigation found widespread bacterial contamination of undistributed and distributed products from multiple donors, with whole-genome sequencing indicating a common source.<\/p>\n Meaning <\/strong>The findings from this outbreak underscore that unapproved and unproven stem cell products can expose patients to serious risks without clear benefit, including the possibility of product contamination.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.19.4″ global_colors_info=”{}”]<\/p>\n Of unopened, undistributed products sampled for testing, at least 1 of 16 bacterial species contaminated 65% (22 of 34 vials).<\/em><\/strong> [7]<\/a><\/sup><\/p>\n Liveyon reincarnations From an angle not addressed by the FDA, a global review of scientific literature<\/a> across forty studies revealed that \u201cforever chemicals\u201d from toxic plastics were present in 30,000 umbilical cord blood samples.<\/p>\n Further, citing patient reports of adverse events from a Nebraska exosome <\/strong>clinic, the FDA issued a safety warning<\/a> to the public.<\/p>\n What the hell is reactive arthritis after a \u201cstem cell\u201d injection? However, a mismatched case report contradicts their false claim. An open penitentiary? Everybody speeds Doctor: If I need regulatory approval to treat patients with stem cells, how come so many doctors do it anyway? Stories like Jury Convicts State Lawmaker of COVID-19 Fraud Scheme at Springfield Health Care Charity<\/a> and Man falsely claiming to use \u201cStem Cell Therapy\u201d convicted and sentenced to 202 years<\/a> don\u2019t seem to make a difference.<\/p>\n Stem Cells and exosomes for the healthy, wealthy From another angle, just because something is illegal doesn\u2019t mean clever marketers partnering with iconic brands like the Four Seasons have consulted a lawyer specializing in FDA compliance. Or have read the literature cited herein.<\/p>\n Stem Cell Distributor expands dental practices Do Stem Cells Work? A growing body of literature supports Willerson\u2019s supposition: A PubMed Central Search<\/a> returned more than 100,000 publications that discuss adipose-derived stem cells. And over 35 published in-human Celution System studies<\/a> validate the safety and effectiveness of clinical-grade ADRCs.<\/p>\n In contrast, experimenting on patients in dental offices or at ritzy hotels with potentially contaminated \u201cnatural biologics\u201d that contain dead stem cells is a risky pod for patients to swallow.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.18.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.18.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.19.4″ text_font_size=”80%” text_line_height=”1.5em” global_colors_info=”{}”][1]<\/a><\/sup>\u00a0Perin EC. In Memoriam: James T. Willerson, MD (1939-2020). Tex Heart Inst J. 2020 Aug 1;47(4):242-243.<\/p>\n [2]<\/a><\/sup> Fortier LA, Cercone M, Keller LE, Delco ML, Becktell L, Wells KV. Amnion and Umbilical Cord\u2013Derived Products in Sports Medicine: From Basic Science to Clinical Application.\u00a0The American Journal of Sports Medicine<\/em>. 2021;49(7):1954-1961<\/p>\n [3]<\/a><\/sup>https:\/\/legislature.vermont.gov\/Documents\/2020\/WorkGroups\/Senate%20Health%20and%20Welfare\/Bills\/S.252\/Written%20Testimony\/S.252~Jonathan%20Fenton~Consensus%20Statement%20on%20Aggressive%20Marketing%20of%20Birth%20Tissues%20as%20Stem%20Cell%20Therapies~2-28-2020.pdf<\/a><\/p>\n [4]<\/a><\/sup> Berger DR, Centeno CJ, Kisiday JD, McIlwraith CW, Steinmetz NJ. Colony Forming Potential and Protein Composition of Commercial Umbilical Cord Allograft Products in Comparison with Autologous Orthobiologics. Am J Sports Med. 2021 Oct;49(12):3404-3413.<\/p>\n [5]<\/a><\/sup> Panero AJ, Hirahara AM, Andersen WJ, Rothenberg J, Fierro F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine. 2019;47(5):1230-1235.<\/p>\n [6]<\/a><\/sup> Turner L The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions Cell Stem Cell 28, November 4, 2021 <\/p>\n
<\/strong>What do dentists, chiropractors, anti-aging doctors, the Four Seasons Maui Spa, and the Tide Pods Eating Fad Have in Common?<\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2023\/01\/Rob-Gronkowski-saysNo-600x420.jpg\")
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<\/strong>On December 5, 2019,\u00a0 the FDA warned Liveyon Labs, Inc.<\/a> that they were selling unapproved, contaminated umbilical cord stem cell products. At least 300 patients had reported bacterial infections tied to Liveyon\u2019s umbilical cord stem cell products.<\/p>\n
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Sadly, as a chiropractor\u2019s patient with long-Covid and congestive heart failure related, \u201cI tried umbilical cord stem cells. They didn\u2019t work.\u201d There were no live stem cells in the product with which he was treated or other commercially available perinatal vials, studies revealed:<\/p>\n\n
<\/strong>But how does the Tide Pod eating fad relate to the umbilical cord stem cell fad? The Tide Pod teenagers and Umbilical Cord Stem Cell (UBSC) patients share an appetite for risk:<\/p>\n\n
<\/strong>![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2023\/01\/Perinatal-Stem-Cells-600x376.jpg\")
Perinatal refers to just before or shortly after birth. Thus, perinatal stem cells come from birth tissues or fluids, i.e., umbilical cord<\/strong> blood and tissue, placental<\/strong> blood and tissue, and amniotic<\/strong> tissue and fluid.<\/p>\n
<\/strong>![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2023\/01\/Carrier-Pigeon-600x420.jpg\")
Cells release tiny sacs or vesicles called exosomes. Like carrier pigeons, exosomes carry messages to nearby cells.<\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2023\/01\/Bad-Batch-600x600.jpg\")
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<\/strong>Question Were infections in patients<\/strong> who received umbilical cord blood products marketed as stem cell treatment associated with product contamination?<\/p>\n
<\/strong>Yet the warnings failed to stem the umbilical cord stem cell (UBSC) tide nor remove dirty cells:<\/p>\n\n
<\/strong>Promoters of perinatal \u201cstem cell\u201d products claim there is no risk of immune rejection. In other words, they say umbilical cord Wharton\u2019s Jelly does not require human leucocyte antigen (HLA) matching to pair patients and donors, as is done for blood or marrow transplants.<\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2023\/01\/36-yo-man-in-OR-being-examined-600x420.jpg\")
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\u201cA 36-year-old man was injected with Wharton\u2019s jelly for low back pain and within 24 hours developed fevers, chills, polyarthritis, and enthesitis. <\/em>(Enthesitis is\u00a0inflammation of the ‘enthesis\u201d, which is where a tendon or ligament attaches to a bone.) Infectious disease work-up was negative. Inflammatory markers were elevated and his HLA-B27 antigen was positive. Initial treatment included methylprednisolone and sulfasalazine. This case highlights the unknown dangers of these allogenic injections and physicians should remain cautious about their use until further study and regulation can ensure patient safety.\u201d<\/em>[8]<\/a><\/sup><\/p>\n
<\/strong>If these products are not FDA-approved and the labs do not comply with cGMP, how do companies get away with selling them? The manufacturers claim their products are for research purposes or ignore FDA regulations because they could care less.<\/p>\n\n
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A doctor wanting to participate in the stem cell wild, wild west asked a lawyer specializing in stem cell regulatory affairs:<\/p>\n
Lawyer: \u201cDo you speed?\u201d
Doctor: \u201cAll the time.\u201d
Lawyer: \u201cIs it illegal?\u201d
Doctor: \u201cI don\u2019t care.\u201d<\/p>\n
<\/strong>NextHealth at the Four Seasons Maui Resort<\/a> mixes up the mania, offering Vitti Labs\u2019 potentially contaminated umbilical cord \u201cstem cells\u201d and Organicell\u2019s unapproved exosomes in their spa. They offer Stem Cells + Exosomes + Longevity IV Therapy for $16,000, a savings of $2,299<\/strong>.<\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2023\/01\/Spa-Pricing-1024x404.jpg\")
Contrary to the FDA\u2019s warning letters, a NextHealth patient coordinator insisted that Vitti\u2019s and Organicell\u2019s products are FDA-approved and that the manufacturers certify all lots are contaminant-free. Where did she get that idea?<\/p>\n
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At the other end of the spectrum, New Life<\/a>, an Invitrix and Organicell distributor, \u201cworks closely with clinicians and practitioners to enhance their care offerings\u2026and expand their practices with \u201cnatural biologics <\/em><\/strong>(emphasis added).\u201d But their research products page<\/a> and disclaimer tell their customers – dentists, chiropractors, nurses, and doctors \u2013 their products are not FDA-approved.<\/p>\n
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\u201cOf course, they work. We are all walking stem cell products – the sperm, and the egg.\u201d James Willerson, MD, Ph.D. Dr. Willerson went on to publish Buying New Soul (2012). Here he hypothesized that adipose tissue was the best source of adult stem cells.<\/p>\n
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