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

We often undervalue the Power of Simplicity in our health and wellness.

At one end of the spectrum, the standard of care extends our lifespans, i.e., drugs, surgery, and devices.But the average senior sees seven doctors and takes seven meds per year. Thus, we all know someone – or are that someone – who lives with a poor quality of life.Self-proclaimed biohacking broscientists are on the other end of the spectrum.If something might just help your health – no proof required- one of the broscientists will sell or promote it. In doing so, they claim their products, equipment, books, podcasts, and psychedelic drugs are the solution to everything from chronic disease to healthy aging.

The Power of Simplicity
Instead, you can be the hero of your health by taking control of your mind and body with simple lifestyle practices. Better yet, these tools cost nothing but a bit of time. And they bring enjoyment to you and others with whom you live, work, and play.

The pillars of healthy aging are moderate exercise, an anti-inflammatory diet, a strong family, and fun, supportive friends. It’s “too simple.”

• Study after study demonstrates walking would be a trillion-dollar drug – if big pharma could put it in a vial and sell it. Healthline says their top 10 benefits include heart health, lower blood sugar, boosted energy, living longer, creative thinking, and more.
  A trial led by the University of Massachusetts found that walking about three miles per day cut the risk of dying by more than half. Surprisingly, people who walked further or faster did not live longer. According to the Cleveland Clinic, too much exercise can hurt you. In other words, you don’t have to be a weekend warrior to be healthy.
• The Harvard School of Public Health supports the age-old Mediterranean diet. If you start the Mediterranean diet before the age of 80, you will outlive at least three of your friends who eat the western diet. Our Italian, Spanish, and Greek friends who consume more olive oil, fruits, vegetables, nuts, and seafood than Americans have a lower risk of heart disease, stroke, dementia, and depression.
• Dan Buettner studied five communities in Japan, Italy, Greece, Costa Rica, and California. In these five Blue Zones, more 90-year old’s live with vim and vigor than anywhere else on the planet. His talk, How to live to be 100+, ties together the common denominators regarding exercise, diet, community, and purpose that Buettner’s research unearthed. Suffice to say, people in these communities walk a lot.
• At 33, Lissa Rankin, M.D., was a burned-out ob-gyn physician. She was taking seven medications to treat a whole host of conditions.  Her successful search for better personal health led Lissa to mind-over-body medicine.  In her TEDx Talk, Is there scientific proof we can heal ourselves?, Lissa names research studies that show friendships, long-term relationships, a positive frame of mind, and relaxation exceed the benefits of exercise and diet alone.
• In Shut your Mouth and Change your Life, Patrick McKeown explains how simply switching from mouth breathing to nasal breathing improved his asthma, sleep, and focus. Gentle, slow nasal breathing enhances heart health, lung function, sexual fitness, immune strength, and a heightened sense of well-being. He gives new meaning to a breath of fresh air. And breathwork isn’t new: Medical research attributes the benefits of meditation and yoga to it.

But for some people, healthy living isn’t enough, or it came too late.  After failing conventional and integrative medicine, Barbara, Jeff, Tony, Trish, and others credit accessing their adipose-derived stem and regenerative cells (ADRCs) with their improved quality of life. In this way, ADRCs bring a Golden Era of Self-Cell Repair to healthcare.

In summary, these mind-body wellness tools are the keys to the healthspan kingdom.

Conversely, extreme biohacking may just be the new stupid.  In this realm, “broscience” geniuses Dave Asprey, Joe Rogan, and Ben Greenfield score healthcare IQs below the room temperature.

• Dave recommends kratom for focus, energy, and relaxation – while acknowledging it is addictive. The National Institute of Drug Abuse enumerates far more side-effects than Asprey suggests, not the least of which is 11 cases of over-dose induced death.
  And following in the footsteps of Ken Kesey’s work for the CIA’s MK-Ultra mind control program, our Biohacker-in-Chief champions a psychedelic free-for-all.
• Joe advocates the use of synthetic HGH despite the well-documented side effects and his self-described HGH-Bubble Gut. He, too, promotes dangerous psychedelics.
• Greenfield takes mind-altering drugs, pseudo-science, and sex to a new level: While his twin tween boys are eating breakfast, Greenfield mixes vodka and LSD in his homebrew psychedelic distillery. Later, Ben, a self-professed “good Christian” and self-taught psychotropic mixologist, teaches the twins deep breathing and pelvic floor exercises to induce psychedelic-like sexual stimulation.

Like big pharma, biohacking is big business. If we stacked on top of one another all the equipment, products, supplements, coffee, food, books, course materials, franchise documents, blog posts, and transcripts the big three market, it would be the height of a 10-story super-store.

The polar opposites are the stars of the back-to-basics formula.  They are everyday folks who enjoy life into their 80s, 90s, and 100s with intact memories, healthy hearts, and rich social lives.

The millions of scientific papers supporting the Power of Simplicity in health could encircle the earth.On a personal basis, the pillars of the Power of Simplicity encompass the future of healthy, happy, and dignified aging. And you can splurge on them without having to spend any money at the Biohacking Superstore.

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

Amy’s Six-Year Patient-Reported Outcome Suggests So.

After living with severe diabetic neuropathy and fibromyalgia, in 2014, Amy, a then 24-year-old T1 diabetic, accessed the stem cells and other regenerative cells in her fat (adipose tissue) to improve her quality of life. That single treatment of adipose-derived regenerative cells (ADRCs) marked the turning point in Amy’s battle with diabetes. Amy’s every day went from being ruled by her foot pain to playing soccer, hiking the Grand Canyon, and living life to the fullest.

Amy didn’t go on a highly restrictive diet or make radical lifestyle changes on her way to improved symptoms, function, and quality of life. That isn’t to say those tools aren’t helpful for some; Amy just didn’t need them after cell therapy. Neither are we saying that her food choices and exercise regimens weren’t healthy; they just weren’t extreme.

To put Amy’s patient-reported outcome in perspective, let’s contrast it with the standard of care for chronic disease. A single dose of medicine rarely, if ever, provides lasting benefits. We often take prescribed drugs for life – unless they don’t work or the side-effects are not bearable by the patient.

Seniors, on average, take seven medicines and see seven doctors per year.

Those pursuing a more natural route take supplements daily, repeat integrative therapies for extended periods, go to the chiropractor when their bones and muscles go out of tune, and so forth.

The standard of care for people living with diabetes, concurrent with other diseases (co-morbidities) requires the patient to take multiple drugs daily to address each condition.

Not to be glossed over, Amy’s improvement for multiple morbidities resulted from a single, same-day treatment with ADRCs. Her benefits from cell therapy have now spanned more than six years and continue. If Amy needs a repeat treatment at some point or another, her win would still indicate a new standard of care for patients living with diabetes is afoot.

Or, as better put by Amy, instead of living in constant fear of her next flare, she can dream again. Broadly speaking, ADRC-based treatments bring creditable hope to people living with diabetes and related illnesses.

Notably, other tools can provide significant benefits to people with diabetes. For people living with T1D like Amy, continuous glucose monitoring (CGM) paired with an automated insulin pump makes a positive difference. For those with T2d, diet and managing blood sugars with CGM can change the disease’s progression or, if caught early enough, reverse it.

Amy’s self-cell therapy (using ADRCs) changed the course of her life. Her results and others like her signal that a Golden Era of  Diabetes Care has begun.

You can find Amy’s Patient-Reported outcome here.

Tony had tried pretty much everything that conventional medicine had to offer. He had also given natural solutions such as supplements, hormones, and diet changes a shot as well, yet he was still in pain. Tony was facing multiple joint replacements and surgeries.  A new law, the Federal Right to Try Act of 2017, empowered Tony to try a new option. His 18-month patient-reported outcome is remarkable. As he reported, “To be candid, the difference in the quality of my life is just unbelievable. You can’t describe to someone what it is like to live without that ever-present and often excruciating pain.” Is a Golden Era of Healthcare within our grasp?

Many millions of people live with (and die because of) poor health despite treatment with surgery, drugs, and devices (the standard of care).  Doctors refer to these patients as “no-option.” They are considered resistant to treatment. Put simply, the standard of care isn’t working well – if at all – for no-option patients.  Some get relief from natural solutions such as diets, supplements, and the like (integrative medicine). But many, including Tony, also fail to achieve sustained benefit from those.

In 1991, Arnold Caplan, Ph.D., in his foundational paper, Mesenchymal Stem Cells. created a vision “for the emergence of a new therapeutic technology of ‘self-cell repair’ (emphasis added).” With that, Dr. Caplan conceived of a new standard of care for no-option patients like Tony and set the foundation for a Golden Era of Healthcare.

We will dig into what Self-Cell Repair means and how the science has evolved since Dr. Caplan first presented its potential. We will also share Tony’s full patient-reported outcome. And fill in the blanks on the Right to Try Act of 2017.

Healthcare’s Gordian Knot
The term “Gordian knot” is commonly used to represent an unsolvable problem. A Roman historian described it as “several knots all so tightly entangled that it was impossible to see how they were fastened.” The name traces back to a legendary event where Alexander the Great used his wit and cunning to cut the Gordian Knot.

Alexander’s feat is trivial compared to untying the intricate web of tangles involved in caring for no-option patients.   This dilemma is even more complicated than it may first appear.

• Over 100 million American adults are living with two or more chronic illnesses (co-morbidities).
• For seniors, it is even more daunting: 68% (38 million) have two or more, and 40% (22 million) have five or more chronic conditions, respectively.
• On average, those 65 and over go to seven doctors and take seven meds per year.^[1]

Epic Failure of Conventional Medicine
All of us know someone who is living with one or more chronic conditions:

• Perhaps a friend had back surgery, and two years later, they are back in the soup with disabling pain. There are more than 4 million patients with “failed back” (surgery) syndrome.
• Or, a family member has both heart disease and diabetes. Over 10 million people in the U.S. have this life-threatening combination.
• More than 2 million patients in the U.S. have both rheumatoid arthritis and psoriasis. R.A. involves inflamed and painful joints. Psoriasis is a skin disease. The combination of the two is so prevalent it has morphed into one diagnosis, psoriatic arthritis.
• Over 20 million Americans live with incurable neuropathies (nerve pain or numbness).

Our reliance on conventional medicine is rooted in thousands of years of development and practice. Corporations, investors, government agencies, and research institutions invest hundreds of billions per year to improve the standard of care. Yet, as the stats above tell us, the number of people living with one or more chronic diseases has become a crisis of magnitude.

• The conventional drugs used to treat long-term maladies such as rheumatoid arthritis (R.A.), Parkinson’s Disease, heart disease, and diabetes cost between $25,000 – $50,000 (or more) per year.
• Worse, these meds do not cure the prescribed for conditions – and they often come with intolerable side effects. For too many ill people, “the cure is worse than the disease”;
• Hence, many patients discontinue use or refuse to take their prescribed drugs—non-compliance then piles on even more cost.

Despite the costs and risks, big pharma makes tens of billions off of their blockbuster drugs. And, they unapologetically raise prices 10% a year in and year out.

Tony was just one of the millions of patients in search of a new standard of care.

What is Self-Cell Repair?
Returning to Dr. Caplan’s 1991 paper, Mesenchymal Stem Cells, he described MSCs as adult stem cells. He explained that MSCs could change into (differentiate) into multiple tissue types as well as neurons and blood vessels and self-renew. In other words, he hypothesized that MSCs would grow of new heart muscle, cartilage, nerves, or blood vessels in man.

A Surprising Discovery
In an unexpected twist, Dr. Caplan proposed to change the name of MSCs to Medicinal Signaling Cells in 2010. He wants to drop the reference to stem cells altogether.^[2]  To paraphrase his thinking, MSCs release hundreds of beneficial signaling molecules called cytokines. These cytokines tell the resident stem cells at the site of injury or disease to do their jobs. As it turns out, the benefits of MSCs come from what the cytokines do rather than what the MSCs become.

In other words, we have our own personalized “pharmacy” that knows how our body and its systems work. When there is something abnormal or out of balance, the cytokines go to where they are needed – sites of inflammation.  They then signal the resident stem cells to get to work and set it right. This nearby cell-to-cell communication is called the paracrine effect.

As a testament to Dr. Caplan’s vision and research, according to a PubMed search, there are over 150,000 published papers that discuss MSCs and 1,000 trials registered on Clinicaltrials.gov, respectively.

What does fat have to do with all that?
The game-changing breakthrough came in 2001 when Patricia Zuk Ph.D. and others, working in the labs of UCLA, discovered MSCs residing in our fat.^[3]   And that adipose-derived MSCs were more accessible, abundant, and potent than those from the bone marrow.

Dr. Zuk’s finding advanced a prior discovery: In the 1960s, a Nobel Prize winner, Martin Rodbell, had isolated a population of regenerative cells in our fatty tissue.

In other words, there is a mixed population of stem cells and other regenerative cells in our fat. When clinical grade, this diverse mix of cells are called Adipose-Derived Regenerative Cells (ADRCs).

Dr. Caplan’s, Dr. Rodbell’s, and Dr. Zuk’s breakthroughs are the foundation for a new standard of care and a Golden Era of Healthcare.

The Gold Standard for Judging Outcomes for Patients like Tony?
Magnetic resonance imaging (MRI) is a test that uses powerful magnets, radio waves, and a computer to make detailed images of the inside of your body. Doctors use MRIs to diagnose everything from the brain to the heart and other organs, as well as your spine and joints. They also use these tests to see how well you’ve responded to treatment.

While MRIs are considered the gold standard for diagnostic imaging, there is a problem with relying solely on their findings. That is because a patient’s symptoms and dysfunction often do not correlate with their structural abnormalities. As but one of many possible examples, patients with significant back pain can have MRIs that are not so bad, yet they are more symptomatic than those with imaging that shows severe signs of degeneration.

The medical establishment relies on MRIs and other diagnostic tests to establish objective evidence that surgery or other treatment worked. In contrast, patients care about their quality of life.

As Tony put it:

What is the “Right to Try”?
“Right to Try” is a new way to express our fundamental “right to life” and “right to health.”

On May 30, 2018, an enlightened and extraordinarily humanitarian bill, The Federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act), was signed into law by President Trump. ^{[4] [5]}  The law provides patients who are seeking new treatment options not approved by the FDA the right and opportunity to do so. The law empowers no-option patients to take control of their health.

Importantly, not all patients with chronic disease meet the criteria. The patient and their doctor determine eligibility under the law.

Golden Era of Healthcare
The great monuments, art, philosophy, architecture, and literature of the Golden Age of Greece (500 BC – 300 BC) are the building blocks of western civilization.

The architects of self-repair cell therapies and the Federal Right to Try Act provide the building blocks for a Golden Era of Healthcare – and a new standard of care for patients like Tony.

To find out whether you might qualify for AMBROSE Cell Therapy under the Right to  Try law, please click here.

To read more about AMBROSE Cell Therapy patient-reported outcomes, including Tony’s, please click here.

[1] http://www.webmd.com/healthy-aging/features/how-many-drugs-are-you-taking#1

[2] A Caplan Mesenchymal Stem Cells: Time to Change the Name! Stem Cells Translational Medicine 2017;6:1445–1451

[3] PA Zuk et al Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng 2001

[4] https://www.congress.gov/115/bills/s204/BILLS-115s204enr.pdf