“People often ask if stem cells work. Of course, they work. We are all walking stem cell products – the sperm, and the egg,” the revered James Willerson, MD, Ph.D. said in a talk in 2011.^[1]

The Tide Pod Teenage Eating Fad, Gronk, and Reverse Psychology
What do dentists, chiropractors, anti-aging doctors, the Four Seasons Maui Spa, and the Tide Pods Eating Fad Have in Common?

In 2018, the Teenagers Eating Tide Pods Fad resulted in 10 deaths and 37 reported poison cases.

Proctor and Gamble, Tide’s manufacturer, went on the offensive to protect kids from poisoning themselves.

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 resulted in more teens taking the challenge.

Contamination, the FDA, and Reverse Psychology
On December 5, 2019,  the FDA warned Liveyon Labs, Inc. that they were selling unapproved, contaminated umbilical cord stem cell products. At least 300 patients had reported bacterial infections tied to Liveyon’s umbilical cord stem cell products.

One day later, the agency issued a press release informing manufacturers, providers, and the public of Liveyon’s issues and the broader scope of their concerns. The other recipients were RichSource Stem Cells, Inc., Chara Biologics, Inc., and R3 Stem Cell, LLC. In total, FDA issued  350 warning letters to manufacturers, healthcare providers, and clinics.

The result: Increasingly, chiropractors, dentists, naturopaths, integrative doctors, infusion clinics, orthopedists, and so on treat patients with unapproved, potentially contaminated, dead stem cells.

Who Killed the Stem Cells
Sadly, as a chiropractor’s patient with long-Covid and congestive heart failure related, “I tried umbilical cord stem cells. They didn’t work.” There were no live stem cells in the product with which he was treated or other commercially available perinatal vials, studies revealed:

• Cell viability in the cord blood product was less than reported by the manufacturer, the cells were primarily leukocytes, no stem cells were present…”^[2]
• The aggressive marketing approach currently used by practitioners and clinics regarding various birth tissue products as safe and effective “stem cell therapy” is not supported by the existing scientific literature. ^[3]
• CFU-Fs, often referred to as stem cells, were not found within any of the commercial UC (umbilical cord) allograft products analyzed, and clinicians should remain wary of marketing claims stating otherwise. ^[4]
• Amniotic fluid has been proposed as an allogenic means for introducing MSCs. This study was unable to confirm that commercial AFPs (amniotic fluid products) contain MSCs. ^[5]

Risk Appetite
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:

• The more Proctor and Gamble warned kids of the danger of eating Tide Pods, the faster the fad grows.
• The more FDA warns providers and patients of perinatal stem cells and their exosomes’ risks, the more the fad is becoming a frenzy too.

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]

More on risk-taking later. First, what are “perinatal stem cells”?

Perinatal Stem Cells
Perinatal refers to just before or shortly after birth. Thus, perinatal stem cells come from birth tissues or fluids, i.e., umbilical cord blood and tissue, placental blood and tissue, and amniotic tissue and fluid.

That sounds good on the surface, but as explained in The Cell Source Debate, mesenchymal stem cells (MSCs) are rare in birth tissues and fluid. There is more to that part of the story to follow.

Exosomes
Cells release tiny sacs or vesicles called exosomes. Like carrier pigeons, exosomes carry messages to nearby cells.

All cells with DNA – cancer, tissue, immune, blood cells, etc. secrete exosomes.

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.

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 “stem cell physician” touts one billion exosome vials – without evidence that more is better, much less sterile or safe.

Lab techs must multiply the MSCs or exosomes in culture to obtain a relevant dose.  However, maintaining current Good Manufacturing Practices (cGMP) requires adherence to rigorous standards.

Whodunnit?

Wondery’s ten-episode whodunnit, Bad Batch, illustrates the significant safety risks Liveyon’s slick marketing and non-sterile lab practices delivered to patients. In sum, over 200 patients reported severe adverse events.

Additionally, the CDC published its lab findings in the Journal of the American Medical Association (JAMA) in 2021.

Key Points
Question Were infections in patients who received umbilical cord blood products marketed as stem cell treatment associated with product contamination?

Findings In this case series, 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.

Meaning 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.

Of unopened, undistributed products sampled for testing, at least 1 of 16 bacterial species contaminated 65% (22 of 34 vials). ^[7]

Liveyon reincarnations
Yet the warnings failed to stem the umbilical cord stem cell (UBSC) tide nor remove dirty cells:

• Utah Cord Bank May 2021 Warning Letter
• Vitti Health July 2022 Warning Letter
• Invitrix Nov 2022 Warning Letter

From an angle not addressed by the FDA, a global review of scientific literature across forty studies revealed that “forever chemicals” from toxic plastics were present in 30,000 umbilical cord blood samples.

Further, citing patient reports of adverse events from a Nebraska exosome clinic, the FDA issued a safety warning to the public.

What the hell is reactive arthritis after a “stem cell” injection?
Promoters of perinatal “stem cell” products claim there is no risk of immune rejection. In other words, they say umbilical cord Wharton’s Jelly does not require human leucocyte antigen (HLA) matching to pair patients and donors, as is done for blood or marrow transplants.

However, a mismatched case report contradicts their false claim.
“A 36-year-old man was injected with Wharton’s jelly for low back pain and within 24 hours developed fevers, chills, polyarthritis, and enthesitis. (Enthesitis is inflammation of the ‘enthesis”, 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.”^[8]

An open penitentiary?
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.

• Invitrix and Vitti Labs use disclaimers to stay one step ahead of the law.
• Organicell hides behind the veil of several planned or ongoing phase 1 clinical trials.

Everybody speeds
A doctor wanting to participate in the stem cell wild, wild west asked a lawyer specializing in stem cell regulatory affairs:

Doctor: If I need regulatory approval to treat patients with stem cells, how come so many doctors do it anyway?
Lawyer: “Do you speed?”
Doctor: “All the time.”
Lawyer: “Is it illegal?”
Doctor: “I don’t care.”

Stories like Jury Convicts State Lawmaker of COVID-19 Fraud Scheme at Springfield Health Care Charity and Man falsely claiming to use “Stem Cell Therapy” convicted and sentenced to 202 years don’t seem to make a difference.

Stem Cells and exosomes for the healthy, wealthy
NextHealth at the Four Seasons Maui Resort mixes up the mania, offering Vitti Labs’ potentially contaminated umbilical cord “stem cells” and Organicell’s unapproved exosomes in their spa. They offer Stem Cells + Exosomes + Longevity IV Therapy for $16,000, a savings of $2,299.

Contrary to the FDA’s warning letters, a NextHealth patient coordinator insisted that Vitti’s and Organicell’s products are FDA-approved and that the manufacturers certify all lots are contaminant-free. Where did she get that idea?

From another angle, just because something is illegal doesn’t 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.

Stem Cell Distributor expands dental practices
At the other end of the spectrum, New Life, an Invitrix and Organicell distributor, “works closely with clinicians and practitioners to enhance their care offerings…and expand their practices with “natural biologics (emphasis added).” But their research products page and disclaimer tell their customers – dentists, chiropractors, nurses, and doctors – their products are not FDA-approved.

Do Stem Cells Work?
“Of course, they work. We are all walking stem cell products – the sperm, and the egg.” 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.

A growing body of literature supports Willerson’s supposition: A PubMed Central Search returned more than 100,000 publications that discuss adipose-derived stem cells. And over 35 published in-human Celution System studies validate the safety and effectiveness of clinical-grade ADRCs.

In contrast, experimenting on patients in dental offices or at ritzy hotels with potentially contaminated “natural biologics” that contain dead stem cells is a risky pod for patients to swallow.

Sam’s Patient Reported Outcome

Sam was a productive dentist, recreational golfer, proud parent, and happy husband. However, in 2013 his wife Flo, a retired physician, began a bold twenty-year battle to reverse his dementia, vascular disease, and pre-diabetes. In April 2020, Sam suffered a stroke and contracted Covid and pneumonia in the hospital. He remained there for two months.

In March 2022, Sam and his wife, Flo, exercised Sam’s Right-to-Try AMBROSE Cell Therapy. Seven months later, he stated, “I am a new man. I have much more energy. My thinking is clearer. I was worried about myself at one time, but not anymore.”

We will return to Sam’s story in a moment; first, some background on the power of blood flow and the risks of ischemia (lack of blood flow).

Sam’s Lifeblood –
Ancient Eastern societies (Phoenicians, Persians, Egyptians, and Hebrews) attached beliefs about blood to the origins of religion. Some Greek savants considered blood the same as the soul or spirit.

Further, the Greeks developed the first scientific considerations about blood. Back in Homer’s time (8^th or 9^th Century BC), they summarized four concepts that remain valid to day:

a) Blood is essential for life
b) Death is considered final when a lack of blood causes it
c) Clashes in which murder and blood make their appearance are horrible
d) Tribes, nations, and families regard blood as a bond

Finally, the Greeks believed good and virtuous blood characterized a courageous, valiant, and principled person.^[1]

Following the Ancients’ theme, Merriam-Webster defines lifeblood as “the seat of vitality.” 

Ischemia – Sam’s life suck
In 1885, Rudolph Virchow coined “ischemia” to characterize the lack of blood flow in an organ or tissue. In plain words, ischemia means blood is not moving through your capillaries, blood vessels, veins, or arteries.

The Po River nourishes Northern Italy’s expansive farms. But 2022’s global heat wave starved Italy’s breadbasket of vital nutrients and harmed the economy,

Similarly, Sam’s blood flow feeds his cells, tissues, and organs, but inflammation-induced ischemia sucked the vitality from Sam’s life.

Sam’s long decline

• Ten years of smoking
• Decades-long mercury exposure from practicing dentistry; he retired in 2008
• He ate the standard American diet (SAD) plus over-indulged in mercury-laden sushi.
• In 2002, he had surgeries for a torn rotator cuff and a fractured left wrist.
• In 2013, a noticeable cognitive decline set in. His Montreal Cognitive Assessment or the MoCA Test— had diminished to 16 out of 30, or about half of normal. MoCA is the most sensitive test available for measuring dementia.^[2]
• In 2016, Sam’s doctors diagnosed him with vascular dementia and pre-diabetes.
• Somewhere along the line, he developed chronic lower back pain.
• In 2020, he suffered an ischemic stroke and contracted Covid and pneumonia in the hospital, where he remained for an additional two months.

In short, Sam’s diffuse (widespread) vascular, metabolic, and musculoskeletal disease foretold of dementia and the stroke yet to come.^{[3] [4]}

Sam’s history epitomizes the complexity of age-related ill health:

• Many of the factors associated with heart disease – for instance, high blood pressure, high cholesterol, and smoking are evident in patients with dementia and Alzheimer’s Disease (AD).
• A common cause of dementia is cerebrovascular disease or damage to the blood vessels in the brain.
• Elevated mercury levels are a less well-discussed culprit of heart disease and neurodegenerative conditions.
• The risk of vascular dementia increases with a stroke.

Flo’s Relentless Quest
In 2016, Flo found Dr. Dale Bredesen and the RECODE protocol. For several years Sam responded to RECODE. His MoCA score improved from 16 to 19.

Unfortunately, Sam’s vascular disease caught up with him in early 2020. He had a stroke and contracted Covid and pneumonia in the hospital, requiring a two-month stay. Research has since revealed that the Corona-19 virus attacks the endothelium (inner lining of the blood vessels), adding more risk to Sam’s future. ^[5]

In 2021, Flo, a retired physician, became concerned that her husband had plateaued. After researching stem cell therapy options, she recommended Ambrose Cell Therapy to Sam in 2022.

Sam’s Disease Progression
Sam’s first sign of ischemia was elevated blood pressure or hypertension (HTN). “His BP became a problem at least ten years ago.”, recalled Flo.

Cardiologists refer to HTN as the silent killer because it leads to heart attacks and strokes.

From 2009 to 2019, the deaths attributable to high BP rose by two-thirds, an astonishing number considering that one in four adults take antihypertensive medications.^{[6] [7]}

• Every cigarette Sam or anyone smokes causes a temporary rise in blood pressure. And smoking leads to hardening and narrowing of the arteries (atherosclerosis). Thus, a smoker’s blood is more likely to clot, forcing the heart to work harder.
• Mercury toxicity correlates with hypertension, coronary heart disease, cerebrovascular incidents, and atherosclerosis.
• Insulin resistance, i.e., pre-diabetes, is associated with low cerebral blood flow (perfusion).
• Pre-diabetes, a hallmark of metabolic syndrome, links to vascular dementia. ^{[8] [9] [10] [11] [12]}

Flo’s Distrust
Flo, a retired physician, lacked confidence in the standard-of-care drugs, e.g., Donepezil (Aricept) and Memantine (Namenda). “I didn’t let the doctors put Sam on those medications. I saw they had short-term benefits but could make things worse with long-term use.”

A British study published in 2004 suggested that Aricept has “disappointingly little overall benefit and is not worth the cost.”

Flo also knew to steer clear of drug combinations, including anti-depressants, anti-psychotics, anti-seizure, and sleep meds (polypharmacy). Neurologists prescribe polypharmacy to patients with neurodegenerative diseases despite its well-documented contribution to the progression and severity of dementia. In other words, drug companies profit, and patients pay the price. ^{[13] [14] [15] [16]}

In May 2022, Sam presented to Ambrose with:

• Vascular dementia
• Post-stroke left-side imbalance and difficulty swallowing
• Elevated blood pressure, controlled with medication (Losartan)
• High cholesterol
• Pre-diabetes HbA1C 6.3, fasting glucose 106.
• High inflammatory markers, including homocysteine – 8.4
• Chronic lower back pain
• Shoulder arthritis
• Reclusive and depressed

Harnessing Sam’s Innate Biology
Flo believed in the body’s power to heal itself. That is why she was attracted to the RECODE protocol.

After Sam’s improvement stalled, she took the logical next step of researching stem cell therapy. But Google search results ranked common misinformation high. “Aren’t umbilical cord stem cells (UBSCs) more potent and effective than fat stem cells?” she asked.

Our critical review of Tony Robbin’s Life Force sets the record straight: Researchers have established that ADRCs are the most accessible, abundant, and potent cell population. Contrary to the extant dogma, stem cell depletion does not apply to ADRCs.^[17]

Dozens of peer-reviewed studies supported the potential to treat Sam’s combined disabilities in a single outpatient procedure.

Making an informed choice
Flo requested papers supporting potential benefits for Sam’s memory.

• In 2017 the University of Louisville’s Cardiovascular Innovation Institute demonstrated that intravenous delivery of ADRCs could improve blood vessel health. They predicted “the intravenous delivery of this therapeutic cell population would significantly improve tissue perfusion (the passage of blood), particularly in diseases with diffuse (widely spread) vascular involvement.”^[18]
• A just-published Japanese poster presentation reported remarkable improvements in MOCA scores after IV infusion of adipose-derived–mesenchymal stem cells (ADSCs or Ad-MSC).^[19]
• Another study out of Japan demonstrated, “Treatment with Ad-MSC significantly improved HDL, LDL, and remnant-like particle (RLP) cholesterol levels…These findings suggest that Ad-MSC administration is safe and effective in patients developing arteriosclerosis, thereby providing an attractive tool for anti-aging application.^[20]
• Japanese researchers from Nagoya University concluded in a 2022 review article, Adipose-derived regenerative cells as a promising therapy for cardiovascular diseases: an overview, “Therapeutic angiogenesis (new blood vessel growth) has been developed as a new treatment strategy for such patients.” ^[21]

 Ischemia – the Tip of the Iceberg
A robust body of literature confirms that ischemia is just the tip of the dementia iceberg. As we have discussed in articles on cell-assisted brain care, aging, and long-Covid recovery, chronic disease involves multisystem dysregulation.

A Golden Era of Self-Cell Repair details the research and discovery path upon which we base Ambrose Cell Therapy’s safety and potential effectiveness.  ^[22]

Sam’s Personalized Protocol
Per the Ambrose Master Protocol:

1. Ambrose’s board-certified plastic surgeon harvested 370 ccs of adipose tissue. The Celution™ System processed 310 ccs yielding 68 million ADRCs with 92% viability.

2. Ambrose’s fellowship-trained interventional pain specialist utilized the remaining 60 ccs to deliver 44 injections of PRP-enriched micro-fat:

• Para-spinal and para-facet injections -24
• Right shoulder -13
• Left wrist – 7

Summary of Benefits
Per Flo, over ten months, Sam went from reclusive, demented, and in chronic back pain to socializing with friends, playing an occasional round of golf, and enjoying his grandchildren.

He helps Flo with chores and preparing dinner and takes the initiative to attend church, meditate, and exercise. He engages in conversation without repeating himself. Flo wants to see his short-term memory improve but acknowledges Sam’s significant quality of life improvement.

Consistent with the studies Ambrose provided to Flo, objective evidence indicates cell therapy lowered Sam’s risk of another catastrophic stroke or a heart attack.

• His blood pressure normalized -120/80 or better most days – allowing him to discontinue losartan in the first few weeks following Sam’s Ambrose.
• His metabolic health and systemic inflammation showed remarkable improvement.
  • HbA1C – 6.4 to 5.3
  • Fasting glucose – 106 to 99
  • Homocysteine – 8.4 to 6.0

Sam’s cholesterol remained high until Flo put him on Zetia and a low dose of Crestor. The keto diet raises cholesterol in some and lowers it in others.

Setbacks
To be clear, Sam has had a few setbacks, including a bout of severe constipation. Diet changes resolved that issue.

He also had a flare of debilitating back pain. Notably, his current MRI shows multi-level spinal degeneration and facet arthritis. However, his months of better function, including long walks and restarting golf, lend credence to the Ambrose Cell-Assisted Spine Care Hypothesis.

With rest and conservative physical therapy, Sam said, “My back is better.” He resumed his daily walks a few weeks later.

Sam’s Perspective
“Stem cells are the future. I am a new man. I have much more energy. I am thinking much more clearly. I was worried about myself at one time, but not anymore.”

“It’s going well. I am doing very much better. I am playing golf. We are visiting our son and grandchildren in Hamptons this weekend,” declared Sam.

He had quit golf four years ago and had not visited his family in several years.

Details – Sam’s improving quality of life timeline (edited for brevity and clarity):

• April: Not repeating questions as often, short-term memory starting to improve. Sam’s masseuse noted he didn’t repeat the same question. And Sam asked about her daughter for the first time. He initiated going to exercise, church, and meditating.
• His blood pressure normalized. He discontinued losartan.
• May – Sam surprised Flo with Mother’s Day Flowers and teased her that her boyfriend from high school must have sent them.
• June – He played golf after quitting four years ago. Flo: “Good news Matt, we played golf – 9 holes, he had fun even though he didn’t play well, but he was able to give me some instructions and vice versa. Beautiful day today. He was fine and willing to go when I brought it up. I was so happy.”
• Left side imbalance from stroke is no longer evident. “He keeps his balance when walking. Swallowing is better.”, said Flo.
• Their son, Fred, a prominent healthcare mutual fund manager, acknowledged, “Dad is getting better.”, which is also a first.
• Sam and Flo had dinner with friends in New York City: “We had a good time. Sam had a good conversation with the others. However, he was not in a good mood. It looks like he got out of the wrong side of the bed. Sam did have these kinds of moments a lot, but recently it is unusual.”
• July – “I have good news this morning. My brother called Sam for his birthday. He did really good. Usually, he talks a little and hands me the phone, but this time they had a long conversation with laughs and jokes. I haven’t seen this for a long, long time. I think it is really positive progress.”
• August – Sam spoke for himself rather than deferring to Flo on a one-hour follow-up call. “I am a new man. I have much more energy, much more clear thinking. At one time, I was worried about myself, but not anymore,” he stated.
• Sam and Flo drove to the Hamptons to see their son and children. Their daughter’s family joined them. “Today, Sun played golf with our son, Fred, and our son-in-law, Jim. He had a good round. This trip was the first time Sam packed his things by himself. He didn’t have much anxiety like before…definitely improved. Jim said, ‘Dad is doing better for sure. Whatever I’m doing is helping him. When he played golf, his back was fine.”, Flo shared after the gathering.
• “We spent all afternoon (at the US Open) watching Medvedev and Coco play in Ashe Stadium. It was fun to be there and feel the action. Overall, we had fun watching the tennis and excitement.”
• September – Back to East Hampton for their grandson’s birthday. “Our son was surprised we stayed that long. Sam had fun and mingled with the guests. He didn’t have any issues.”
• October – Flo reports, “I have some good news. We went to speech therapy. Sometimes I don’t hear him well. The therapist asked him lots of questions. She did not want me to answer for Sam. I was delighted to see his improvement.”
• December 9 – Last night, Sam had a good conversation with his longtime friend in LA. They chatted with each other, including me. Sam was engaged in the conversation. It made me happy. At first, he didn’t remember it the next day, but after a little hint, he got it and remembered.”
• From Flo: “Sam’s phone has Face ID. I tried to help him log into Fidelity; of course, it didn’t recognize his face. He said, ‘how could you not recognize my wife’s face? Everything in there is hers!’”

As 2022 came to an end, Flo said, “Matt, I’d like to thank you for your support all year long. It’s been a great year for us.”

RJ’s Patient-Reported Outcome

Sports-related injuries, including concussions and whiplash, three failed shoulder surgeries, an unsuccessful right knee surgery, etc., retired RJ’s dream of playing Major League Baseball.

In May 2022, he exercised his Right to Try AMBROSE Cell Therapy. Seven months later, he says, “Y’all (AMBROSE) changed my life.”

In 2016, Barbara suffered from debilitating spinal stenosis. After failing to respond to chiropracty, physical therapy, medication, and steroids, Barb accessed a new option: The stem cells and other regenerative cells residing in her fat or adipose-derived regenerative cells (ADRCs). Five years since her treatment, Barb says that cell therapy “saved my future.”

In 2018, Trish, Jeff, and Kathy lived with complex, debilitating health conditions, including spine-related pain. After they had failed to get relief from conventional and integrative medicine, each chose to exercise their Right to Try AMBROSE Cell Therapy under the Federal Right to Try Act of 2017. Remarkably, over two years post-cell therapy, they all report their spine-related symptoms and dysfunction don’t hold them back anymore. But what is the scientific back story that led to their sustained outcomes? And what was the catalyst for a Golden Era of Spine Care?

 Is Conventional Spine Care Antiquated?
Spine care has its origins in antiquity. The Edwin Smith surgical papyrus, an Egyptian document written in the 17th century BC, is the first known discussion of neck and back-related injuries. Hippocrates (4th century BC) experimented with traction or local pressure to correct spinal deformities. Aristotle also contributed to our current day understanding of the neck and spine.

Few individuals in history have made as many contributions to so many disciplines as Leonardo da Vinci. Included in his vast body of work, Da Vinci sketched the first accurate depiction of the spine. ^[1]

As a result, knowledge of the neck and back, and their related disorders, have evolved since the Renaissance Man’s illustrations.

Early researchers proposed that neck and back pain resulted from the stress of heavy loads and age-related wear and tear on the discs. Then, in 1978, White and Panjabi published Clinical Biomechanics of the Spine. Here, they connected all the mechanical factors involved in neck and back health.  Technically speaking, they found that in addition to vertebrae, our muscles, tendons, ligaments, blood vessels, and nerves (soft tissues) play significant roles in spine health and disease. White and Panjabi named those pieces of the puzzle the Functional Spine Unit (FSU).

But there was still more to be discovered than the FSU. More recently, researchers began focusing on the vicious interplay involved with traumatic injuries, wear and tear, inflammation, and other diseases (co-morbidities). For example, patients with heart disease, diabetes, neurologic conditions, and autoimmune diseases have a higher prevalence of spine disorders than others without those conditions. In fact, Barb, Trish, Kathy, and Jeff each lived with other chronic debilitating conditions, including arthritis, hypermobility, kidney failure, and spinal cord injury, respectively. ^{[2] [3] [4] [5]}

In 2001, Patricia Zuk, Ph.D. et al., working in a UCLA lab, accomplished a (non-obvious) leap forward for patients living with neck and back pain. Zuk’s group discovered mesenchymal stem cells (MSCs) were residing in adipose tissue. But how did their seemingly unrelated research catalyze a Golden Era of Spine care? We will answer that in a moment first; why was a new regenerative option needed in the first place?

 Failed Back Surgery Syndrome
Despite those thousands of years of research and development, more people than ever are suffering from spine-related pain. Besides contributing to the opioid epidemic, the number of spine surgeries increases year in and year out.

Unfortunately, downsides to spine surgery, including high rates of complications, readmissions to the hospital, and poor outcomes, are common. ^{[6] [7]} As a result, approximately 4 million individuals live with failed back surgery syndrome (FBSS) in the U.S. Tragically, a spinal fusion gone wrong caused Jeff’s spinal cord injury.

Doctors call those with FBBS and others unwilling to risk a surgical intervention “no-option patients. Jeff’s spinal cord injury resulted from a spine surgery, which upon a second opinion, turned out to be unnecessary in the first place. Barb, Kathy, and Trish opted not to pursue surgery out of concern for those risks.”

 Is there more to spine health than meets the eye?
Circling back, in the early 1500s, Leonardo da Vinci took an unusual interest in tree anatomy. His Rule of Trees explained the balance between the trunk and branches of a tree. He counted the rings in tree trunks to determine “the nature of past seasons.”

Perhaps it wasn’t coincidental that he sketched the spine, tree trunk, and branches, respectively? Let’s look at it this way: The tree’s trunk supports the crown and branches. Likewise, a healthy neck and back do the work of a strong tree.  But even the strongest and thickest tree branch cannot handle a heavy load if the tree’s trunk is weak. Similarly, our legs, arms, hands, and feet can be affected by a degenerated FSU.

Ideally, our spines are a harmony of functional bones and soft tissues. The back and neck rely on all those elements to hold us upright and be mobile. But when the soft tissues atrophy or become arthritic, they pressure nerves, thus contributing to spine-related symptoms.

• Trish lived with sciatica, numbness, stiffness, and pain.
• Kathy’s bad neck kept her awake at night.
• Barbara’s situation prevented her from working, gardening, driving, and pottery.

Most vexing, back-related discomfort doesn’t discriminate: Gardners, crossfitters, weightlifters, golfers, and aging couch potatoes can end up unable to function without pain for varied reasons. ^[8]

ADRCs – the Spine’s Arborist
An arborist cultivates trees; tree removal is a last resort. The first thing that goes through their minds is how to save the tree. To do their jobs, arborists cultivate the whole tree. They use fertilizer, irrigation, and other regenerative tools to restore the tree’s trunk, limbs, and leaves.

Around 2010, Zuk’s discovery of stem cells in fat came into play when some innovative doctors began treating spine patients with ADRC-based protocols. Their strategy was not dissimilar to an arborist’s. They recognized that a veritable pharmacopeia in a person’s fatty tissue could reduce arthritis and regenerate the supportive soft tissues in the neck and lower back. Back surgeries change the anatomy while cell therapy is, well, therapeutic.

Just as an arborist uses an array of skills to rehabilitate diseased trees, ADRCs use multiple mechanisms of action to rehab the FSU. At least as necessary, ADRCs restore balance or homeostasis in the systems that feed, care for, and defend the spine. In other words, better vascular, immune, metabolic, and nervous system wellness contributes to overall improvements.

In summary, not only did AMBROSE cell therapy help Barb, Jeff, Kathy, and Trish avoid risky surgeries, but all reported being more active, increased energy, and an improved sense of wellbeing.

[1] Bowen G et al Leonardo da Vinci (1452–1519) and his depictions of the human spine
Childs Nerv Syst (2017) 33:2067–2070

[2] M. Shamji et al. Proinflammatory Cytokine Expression Profile in Degenerated and Herniated Human Intervertebral Disc Tissues Arthritis Rheum. 2010 July; 62(7): 1974–1982

[3] J Gallo Inflammation and its resolution and the musculoskeletal system J Orthop Translat. 2017 July; 10: 52–67

[4] Asadian et al. Diabetes Mellitus, a new risk Factor for lumbar spinal stenosis: a Case–Control study. Clinical Medicine Insights: Endocrinology and Diabetes 2016:9 1–5

[5] Lotan R, Oron A, Anekstein Y, Shalmon E, Mirovsky Y. Lumbar stenosis and systemic diseases: is there any relevance? J. Spinal Disord. Tech. 2008;21(4):247-51.

[6] Camino Willhuber et al. Analysis of Postoperative Complications in Spinal Surgery, Hospital Length of Stay, and Unplanned Readmission: Application of Dindo-Clavien Classification to Spine Surgery Global Spine Journal July 2018

[7] Chase D. The opioid crisis is partly fueled by insurers and employers’ approach to back pain. StatNews. statnews.com/2019/03/27/opioid-crisis-insurersemployers- back-pain/. Published March 27, 2019.

[8] J Abbas et al Paraspinal muscles density: a marker for degenerative lumbar spinal stenosis? BMC Musculoskeletal Disorders (2016) 17:422

Back to the Future

For Mary, aging was not dying – it was disability; A transformative therapy, using her own Adipose-Derived Regenerative Cells (ADRCs), brought her Back to the Future.

In the summer of 2014, Mary’s doctor admitted her to the Cleveland Clinic ICU. After two weeks, the doctors sent her home with but one recommendation: Prepare for hospice.

Several months later, AMBROSE Cell Therapy’s predecessor group treated Mary with a novel ADRC-based protocol. Seven years after that single treatment, Mary celebrated her 93rd birthday with friends.

In 2021, Mary lived independently, her Parkinson’s symptoms were mild compared to her baseline, and her mood was upbeat. ^[1]  She exercised at the gym four days per week. Her back pain and sciatica had long since resolved.

Science Fiction Becomes Reality
Perhaps the renowned science fiction author Ray Bradbury foretold Mary’s outcome in The Illustrated Man, “She went back to the future,’ he said. ‘I mean it. She was an old woman in a little house in the middle of Wisconsin here, somewhere not far from this place. An old witch who looked a thousand years old in one moment and twenty years old the next, but she said she could travel in time. I laughed. Now I know better.’ “

Mary’s remarkable turnaround turned sci-fi into reality, as often happens with that genre. But how did Mary’s ADRCs help her time travel, particularly with the odds stacked against her?

Mary’s Story
By 86, Parkinson’s had disabled, depressed, and hurt Mary. Tremors prevented her from using a fork and knife.

She lived with chronic back pain and sciatica after a fall that fractured her back in three places. Mary relied on 24/7 care.

In May of 2014, Mary attended her granddaughter’s wedding in a wheelchair. Per her primary care physician, “All the guests were commenting on her deteriorating health and how they did not expect her to survive much longer.”

After spending two weeks in the Cleveland Clinic ICU, the doctors told Mary to get her affairs in order. All this left her depressed with thoughts of suicide.

In October 2014, Ambrose’s predecessor group treated Mary with a novel ADRC-based protocol, which sparked her Comeback to the Future. Seven years after that single treatment, Mary celebrated her 93rd birthday with friends.

She lived independently, her Parkinson’s symptoms were mild compared to her baseline, and her mood was upbeat. Mary walked on the treadmill and worked out at the gym four days per week. Her back pain and sciatica had long since resolved.

Living to 93 is one thing; it’s another to be active and enjoy life despite all odds.

Aging’s Dismal Future
Until cell therapy sparked Mary’s recovery, she shared a dismal future with over 100 million adults. Four out of ten adults live with two or more chronic diseases.

As we age, the situation becomes dire: The average senior sees seven doctors and takes seven meds per year.

Connecting the Dots
At the time of Mary’s treatment, stem cell researchers had not yet connected the common factors of age-related conditions with the cellular mechanisms that enabled Mary’s remarkable reversal of symptoms, function, and quality of life. The secret to going Back to the Future lies in that relationship.

Coming Back to the Future, we now understand that Mary’s ADRCs abided by the laws of nature. But how? Centuries-long research held the clue. And new-age science and technology unraveled the mystery. More on that later, first, let’s catch up with the past.

Back to Nature – Physiology, and Balance
Going Back to the Future requires going back to basics, starting with physiology. Physiology traces its roots to ancient India, Egypt, and Greece.

• Hippocrates, the Father of Medicine, played a crucial role in introducing the Four Humors (bodily fluids). His fifth-century BC treatise, The Nature of Man, defined good health as the balance and mixture of the humors while their imbalance and separation caused disease.
• Jean Fernel (1497-1558), a French physician, introduced the term “physiology,” from Ancient Greek, meaning “study of nature, origins.” In other words, physiology refers to the body’s natural processes, functions, and systems. He published his book The Natural Part of Medicine in 1542.
• In the 1870s, Claude Bernard, a French physiologist, described how complex organisms must maintain balance in their internal environment, or “milieu intérieur,“to lead a “free and independent life” in the world beyond.
• Fifty years later, physiologist Walter Cannon coined the term homeostasis, expanding on Hippocrates’, Fernel’s, and Bernard’s work. From the Greek words for “same” and “steady,” homeostasis refers to the physiologic balance necessary for survival.
• In 1948, biologist Claude Shannon, Ph.D., wrote the Magna Carta of the Information Age, Information Theory. Here, Shannon bridged DNA signaling processes to digital communications. ^[2] His paper ignited the technology revolution. In other words, our iPhones, computers, and the Internet evolved from cellular crosstalk.
• It took another six decades for Arnold Caplan, Ph.D., a stem cell researcher at Case Western University, to connect physiology, homeostasis, and Information Theory to stem cell biology.

Big Pharma’s Profitable Failure
In contrast, Big Pharma ignores these fundamentals in favor of drugs, many with risks than can outweigh the benefits. For example, Dr. Armon Neel Jr. cautions that ten drug classes can cause or contribute to memory loss, brain fog, and fatigue.

Conventional medicine adheres to Big Pharma’s “one drug, one disease” model. Here, doctors prescribe pharmaceuticals that suppress the primary factor causing a disease or a symptom. This approach has done little to improve patients” healthspan with age-related diseases. And it did not work for Mary either.

 In Mary’s case, she was taking Sinemet for tremors, Lyrica for pain, and Cortisone shots for sciatica – at a minimum. Drug companies make a lot of money from multiple drug prescriptions (polypharmacy) – but Mary’s health did not profit to the same degree, e.g., she talked of suicide, a known side-effect of both Lyrica and Sinemet.

Mary’s Comeback
As her daughter said 18 months after Mary’s treatment, “For her back, the results were incredible. She had two fractures in her lower lumbar. A lot of people never would have gotten out of bed, but she’s 87, and we call her the comeback kid. She’s up at the gym almost every day now with her trainer, who sometimes has to ask her to tone it down, so she doesn’t over-exert herself!”

“Beyond that, now she is walking very straight and isn’t shuffling her feet. Occasionally when she’s tired, she’ll veer off a little, but she’s not using a walker or a cane. She is doing really, really well, and a lot of this is due to the stem cell therapy.

Is Mary’s story a placebo effect? It all sounds too good to be true, but other Patient-Reported Outcomes demonstrate Mary’s benefits are not unique to her.

Bridging the Gap

• In the mid-1960s, Martin Rodbell, Nobel Laureate for Physiology or Medicine, isolated a mixed population of regenerative cells in fat or adipose tissue called stromal vascular fraction (SVF). Stroma means connective tissue (fat). Fraction is the cellular fraction liberated from the outer lining of the vessels intermingled in the fat.
• In 1991, Arnold Caplan, Ph.D., envisioned “the emergence of a new therapeutic paradigm, “Self-Cell Repair”. Dr. Caplan postulated that a person’s adult stem cells, which he named mesenchymal stem cells (MSCs), could be used to repair diseased tissues and organs.
  
• Ten years later, UCLA researchers Patricia Zuk et al. discovered the most accessible, abundant, and potent source of MSCs: Adipose Tissue. Zuk’s group bridged the gap between the age-old science of physiology and the new-age medicine of ADRCs.
• Ten years after Zuk’s lab discovery, Dr. Caplan renamed MSCs “medicinal signaling cells,” connecting physiology, homeostasis, DNA signaling, and stem cell biology.
• ADRCs contain DNA in each cell’s nucleus. Thus, they adhere to Caplan’s Medicinal Signaling Cell framework.
• In 2012, Dr. James Willerson and Dr. Emerson Perin from Texas Heart Institute published Buying New Soul. Here, they proposed adipose tissue as the best source of adult stem and regenerative cells – and connected Bradbury’s Back to the Future with ADRCs’ potency late in life. In other words, fatty tissue protects these cells from dreaded stem cell exhaustion.

Notably, over the past 22 years, investigators have published over 85,000 papers discussing adipose-derived stem cells (ADSCs). That is an average of 11 new publications per day. Most impressive, the publishing rate has accelerated to 36 papers per day, nearly four times the historical average.

A Golden Era of Cell-Assisted Aging?
Aging constitutes a sudden or general onset of multiple physiologic imbalances or multisystem dysregulation. Mary’s symptoms were a good example of this.

In 2006, Dr. William Langston, the Michael J. Fox Foundation’s first Chief Science Officer, published The Parkinson’s Complex: Parkinsonism Is Just the Tip of the Iceberg. ^[3] In short, Dr. Langston’s seminal paper stated there is more to PD than the loss of dopamine-producing neurons in the brain.

Instead, Parkinsonism involves multisystem breakdowns. Therefore, he stated, “Rather, we must deal with all aspects of the disease if we are to modify its progress in a way that truly enhances the lives of our patients over the long term.“

Likewise, researchers connect negative systemic influences with heart failure, kidney disease, Alzheimer’s, diabetes, and so on.

Succinctly, as we age, our cells, tissues, organs, and systems lose harmony. ^{[4] [5] [6]}  Instead, multiple conductors direct the orchestra according to their respective interpretations of the score.^{[7] [8] [9] [10] [11]}

In other words, our immune, vascular, nervous, and other systems give dissonant instructions to our cells, tissue, and organs. Simply put, multisystem disharmony is the overarching factor underlying Mary’s symptoms.  ^{[12] [13] [14] [15] [16]}

After her one-time treatment, Mary’s ADRCs restored physiologic harmony.

In scientific terms, her restorative cells secreted hundreds of healing, or trophic factors, that signaled the resident cells to resume playing according to her musical score.

Put another way, Dr. Caplan’s Medicinal Signaling Cell framework performed better than he hypothesized. The cellular cross talk between the MSCs and the resident cells restored multisystem homeostasis.

In the real world, Mary’s mood, energy, motor control, balance, and pain score remain improved for more than seven years.

Further, Mary’s outcome validated Dr. Langston’s 2006 hypothesis. Most important, Mary, her friends, and her family enjoyed her Comeback to the Future.

[2] Schneider T A brief review of molecular information theory Nano Commun Netw. 2010 September; 1(3): 173–180

[3] Langston J W The Parkinson’s Complex: Parkinsonism Is Just the Tip of the Iceberg Annals of Neurology Vol 59 No 4 April 2006

[4] Takuya Kishi Heart failure as an autonomic nervous system dysfunction Journal of Cardiology (2012) 59, 117—122

[5] Sági B et al The prognostic role of heart rate recovery after exercise and metabolic syndrome in IgA nephropathy BMC Nephrology (2021) 22:390

[6] McCaulley M and Grush K Alzheimer’s Disease: Exploring the Role of Inflammation and Implications for Treatment International Journal of Alzheimer’s Disease Volume 2015, Article ID 515248,

[7] Kelleher R, Soiza R Evidence of endothelial dysfunction in the development of Alzheimer’s disease: Is Alzheimer’s a vascular disorder? Am J Cardiovasc Dis 2013;3(4):197-226

[8] Dantzer R. Neuroimmune Interactions: From the Brain to the Immune System and Vice Versa. Physiol Rev. 2018;98(1):477-504.

[9] Amiya E MD PHD et al The Relationship between Vascular Function and the Autonomic Nervous System Ann Vasc Dis Vol. 7, No. 2; 2014; pp 109–119 Online Month May 16, 2014

[10] Tracey K The inflammatory reflex Nature Vol 420 19/26 December 2002

[11] Simora N et al. The Role of the Immune System in Metabolic Health and Disease Cell Metabolism 25, March 7, 2017

[12] Kelleher R, Soiza R  Evidence of endothelial dysfunction in the development of Alzheimer’s disease: Is Alzheimer’s a vascular disorder? Am J Cardiovasc Dis 2013;3(4):197-226

[13] Dantzer R. Neuroimmune Interactions: From the Brain to the Immune System and Vice Versa. Physiol Rev. 2018;98(1):477-504.

[14] Amiya E MD PHD et al The Relationship between Vascular Function and the Autonomic Nervous System Ann Vasc Dis Vol. 7, No. 2; 2014; pp 109–119 Online Month May 16, 2014

[15] Tracey K The inflammatory reflex Nature Vol 420 19/26 December 2002

[16] Simora N et al. The Role of the Immune System in Metabolic Health and Disease Cell Metabolism 25, March 7, 2017