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Spinal Cord Injury Cell Therapy Hypothesis

Spinal Cord Injury Cell Therapy Hypothesis

by | Oct 11, 2021 | White Papers

Spinal Cord Injury Cell Therapy Hypothesis

Background: In December 2018, AMBROSE Cell Therapy pioneered a novel protocol for Jeff, a patient living with a spinal cord injury. Jeff’s 14-month patient-reported outcome chronicled significant improvements in symptoms, function, and quality of life.

In December 2017, Jeff’s spine surgery gone wrong resulted in an SCI and paraplegia. His extended hospitalization led to an abscessed colon requiring an ileostomy.  Compounding matters, he lived with T2 diabetes.

Jeff complained of neck and back pain, neuropathy, scar pain from the ileostomy, claw toes, spasticity, poor balance, diabetes T2, shoulder immobility, and erectile dysfunction (ED).  He took seven meds to manage his symptoms, including opioids.

Our in-depth review of published SCI stem cell therapy studies yielded positive results. Thus, AMBROSE curated the literature and developed a personalized protocol for Jeff.

The treatment strategy was unconventional. Rather than only targeting the spinal cord lesion, the AMBROSE medical team addressed Jeff’s array of complaints in a single procedure using a Master Protocol.

In essence, AMBROSE designed one overarching protocol to treat multiple issues in a single treatment including the injury site, using adipose-derived regenerative cells (ADRCs). Our treatment team then personalizes it for each patient.

Importantly, our previous group’s prior successes using a Master Protocol with over 300 patients living with diverse chronic conditions supported our hypothesis.  (Okyanos Cell Therapy, Bahamas 2014- 2017).

In addition:

  • A subsequent meta-analysis, Transplantation of mesenchymal stem cells for spinal cord injury: a systematic review and network meta‑analysis, validated the safety and effectiveness of MSC-based treatments for SCI. [1]
  • Researchers had published successful case reports using injections of micronized adipose tissue to address SCI-related musculoskeletal conditions, scar pain, and neuropathy. [2] [3]
  • Published trials for other chronic conditions informed.[4] [5]
  • Urology KOLs advised on a sacral-plexus injection sub-protocol to target bladder and bowel dysfunction.

Hypothesis
A wide gap exists between the known pathophysiology of spinal cord injury and the standard of care being relied upon to treat it. Specifically, the damage to the cord incites multisystem dysregulation, including immune, endothelial, metabolic, mitochondrial, and autonomic dysfunction. [6] [7] [8]

Hence, patients suffer from an array of secondary complications.

Further, the overwhelming insult suppresses spinal cord regeneration, limiting functional recovery. Thus, the expected window of improvement for SCI patients is ~12 months.

As an example, Jeff’s symptoms included 24/7 scar pain, neuropathy, bilateral spasticity, bowel and bladder issues, ED, and impaired balance. At 11 months post-injury, Jeff and his physiatrist recognized his progress had leveled off.

Yet, drug discovery focuses on a single mechanism of action to repair the injury site or suppress a symptom. Put differently, the pharma model of one drug, gene, or cell type to treat a disease has made little progress in improving the prognosis for patients living with spinal cord injuries. This approach neglects a deep body of literature documenting the multiple factors and resulting comorbidities that combine to handicap patients like Jeff.

Multiple Mechanisms of ADRCs
In contrast, ADRCs have multiple mechanisms of action (MOAs) targeting all the factors involved in a chronic condition, including multisystem dysregulation. [9]

ADRCs home to sites of inflammation and secrete hundreds of bioactive molecules that are anti-inflammatory, immuno-modulatory, angiogenic, anti-apoptotic, and wound healing.

ADRCs work through cell-to-cell communication or the paracrine effect.

Beyond wound healing mechanisms, ADRCs restore cellular, systemic, and tissue equilibrium (multisystem homeostasis). [10] [11]

In Jeff’s recovery, the restoration of multisystem homeostasis included improved balance, pain scores, bladder, and bowel function, as well as a significant reduction in spasticity.  The net result was an elimination of all drugs, engaging in hardcore gym workouts, a return to racing, learning to fly helicopters and scuba diving, plus playing golf three times a week.  Though not cured or asymptomatic, Jeff is real-world evidence that ADRCs extended Jeff’s recovery window.

In sum, our preliminary evidence indicates that ADRCs can extend or restart the neurologic window of recovery by restoring multisystem homeostasis.

Why Adipose Tissue?
Unlike other tissue sources of adult stem cells, e.g., bone marrow, ADRCs remain accessible, abundant, and potent throughout one’s life. [12] Following liposuction, the Celution™ Cell Processing System (Lorem Cytori, Inc.) centrifuges the lipoaspirate and prepares the ADRCs.

 Why ADRCs

Adipose-Derived Regenerative Cells (ADRCs) are the designation for a clinical-grade preparation of stromal vascular fraction (SVF), a heterogeneous population of cells residing on the outer lining of the capillaries in adipose tissue. The cell mix includes MSCs, endothelial cells (ECs), endothelial progenitor cells (EPCs), fibroblasts, T-regulatory cells (Tregs), macrophages, and other immune cells (leukocytes).[13]

ADRCs secrete significantly higher amounts of trophic factors compared to Adipose-Derived MSCs (ADSCs).[14] Therefore, the ADRC secretome amplifies the MOAs of ADSCs, including but not limited to:

  • Anti-inflammation and Immuno-modulation,
  • Anti-apoptosis,
  • Angiogenesis,
  • Support of growth,
  • Differentiation of local stem cells and progenitor cells,
  • Anti-scarring, and
  • Chemoattraction.

Human studies show ADRCs:

  • Release factors that down-regulate inflammatory-autoimmune markers, including but not limited to TNF-A, TH17, IL6, and IL2, as well as upregulate IL10.
  • Promote the switch from inflammatory macrophages (M1s) to anti-inflammatory macrophages (M2s) via Prostaglandin E2 (PGE2) and the MSCs in the mix.
  • Reduce Endothelin-1 (ET-1), a known constrictor of blood vessels, implicated in spinal cord-blood-barrier disruption after the injury.

  • Assist in the growth and stabilization of new blood vessels by secreting placental Growth Factor (PGF), Stromal-Derived Factor-1 (SDF-1), and Vascular Endothelial Growth Factor (VEGF).

Notably, a close relationship exists between revascularization and improved functional outcomes after SCI. First, a well-vascularized lesion provides a permissive microenvironment for local tissue survival and nerve regeneration. Improved capillary blood flow, angiogenesis, and B-SC-B integrity facilitate functional recovery.[15] [16]

Neurotrophic factors
ADRCs deliver neurotrophic factors (NTFs) to the CNS, PNS, and ANS. Just as fertilizers keep plants healthy and growing, NTFs stimulate the development of new brain cells, brain cell connections, and nerves.
One such trophic factor is the brain-derived neurotrophic factor or BDNF.

BDNF:

  • Repairs the myelin sheathing surrounding the nerves
  • Reduces inflammation and,
  • Prevents apoptosis that results from an injury or disease. [17] [18] [19] [20] [21]

A recent discovery of neuro-immune cells in ADRCs connects their role in enhancing neuroplasticity.[22] [23]

Safety
Since 2007, no ADRC-related adverse events have been reported.[24]

 

[1] Chen et al Transplantation of mesenchymal stem cells for spinal cord injury: a systematic review and network meta‑analysis J Transl Med (2021) 19:178

[2] Cherian C et al. Autologous, micro-fragmented adipose tissue as a treatment for chronic shoulder pain in a wheelchair using individual with spinal cord injury: a case report Spinal Cord Series and Cases (2019) 5:46

[3] Huang S-H, Wu S-H, Lee S-S, Chang K-P, Chai C-Y, Yeh J-L, et al. (2015) Fat Grafting in Burn Scar Alleviates Neuropathic Pain via Anti- Inflammation Effect in Scar and Spinal Cord. PLoS ONE 10(9): e0137563

[4] A Nguyen, A et al Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 170e179

[5] Guo et al Stromal vascular fraction: A regenerative reality? Part 2: Current concepts and review of the literature Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 180e188

[6] Sun et al. Multiple organ dysfunction and systemic inflammation after spinal cord injury: a complex relationship Journal of Neuroinflammation (2016) 13:260

[7] B. Perrouin-Verbe, C. Lefevre, P. Kieny, R. Gross, B. Reiss, M. Le Fort, Spinal cord injury: A multisystem physiological impairment/dysfunction, Revue Neurologique, Volume 177, Issue 5, 2021, Pages 594 605,

[8] Marion et al. Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury—Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study JOURNAL OF NEUROTRAUMA 34:2883–2891 (October 15, 2017)

[9] Caplan A I Mesenchymal Stem Cells: Time to Change the Name! STEM CELLS TRANSLATIONALMEDICINE 2017; 6:1445–1451

[10] Visoso F. J. et al Mesenchymal Stem Cells in Homeostasis and Systemic Diseases: Hypothesis, Evidences, and Therapeutic Opportunities Int. J. Mol. Sci. 2019, 20, 3738

[11] Morris, M.E. et al. (2015), Systemically Delivered Adipose Stromal Vascular Fraction Cells Disseminate to Peripheral Artery Walls and Reduce Vasomotor Tone Through a CD11b+ Cell-Dependent Mechanism. STEM CELLS Translational Medicine, 4: 369-380.

[12] Perin EC and Willerson JT Buying New Soul J Am Coll Cardiol. 2012;60(21):2250-2251

[13]S Kesten and JK Fraser Autologous Adipose Derived Regenerative Cells: A Platform for Therapeutic Applications Advanced Wound Healing Surgical Technology International XXIX

[14] Hirosi Y et al. Comparison of trophic factors secreted from human adipose-derived stromal vascular fraction with those from adipose-derived stromal/ stem cells in the same individuals

[15]Yao C, Cao X and Yu B (2021) Revascularization After Traumatic Spinal Cord Injury. Front. Physiol. 12:631500.

[16] Numan MT et al. Autologous Adipose Stem Cell Therapy for Autonomic Nervous System Dysfunction in Two Young Patients. Stem Cells and Development 2017 26:6, 391-393

[17] Razavi, Shahnaz et al. “Neurotrophic Factors and Their Effects in the Treatment of Multiple Sclerosis.” Advanced Biomedical Research 4 (2015): 53. PMC. Web. 28 Sept. 2018.

[18] J. K. Huang et al Myelin Regeneration in Multiple Sclerosis: Targeting. Endogenous Stem Cells., The American Society for Experimental NeuroTherapeutics, Inc. 2011

[19] T Lopatina et al. (2011) Adipose-Derived Stem Cells Stimulate Regeneration of Peripheral Nerves: BDNF Secreted by These Cells Promotes Nerve Healing and Axon Growth De Novo. PLoS ONE 6(3): e178991

[20] S.  Seigo et al, Uncultured adipose-derived regenerative cells promote peripheral nerve regeneration, Journal of Orthopaedic Science, Volume 18, Issue 1,2013, Pages 145-151

[21] Xu et al Brain-derived neurotrophic factor reduces inflammation and hippocampal apoptosis in experimental Streptococcus pneumoniae meningitis Journal of Neuroinflammation (2017) 14:156

[22] O’Reilly ML and Tom VJ (2020) Neuroimmune System as a Driving Force for Plasticity Following CNS Injury. Front. Cell. Neurosci. 14:187.

[23] Blaszkiewicz, M., Wood, E., Koizar, S. et al. The involvement of neuroimmune cells in adipose innervation. Mol Med 26, 126 (2020)

[24] Lorem Cytori, Inc Unpublished internal data

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A Golden Era of Cell-Assisted Diabetes Care

A Golden Era of Cell-Assisted Diabetes Care

by | Dec 29, 2020 | Articles, Golden Era Articles

A Golden Era of Cell-Assisted Diabetes Care

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.

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If You Are Unique, Why are You Treated As an Average Patient

If You Are Unique, Why are You Treated As an Average Patient

by | Oct 27, 2020 | Articles, Patient Advocacy

If You Are Unique, Why are You Treated As an Average Patient

Kathy’s Patient-reported Outcome – Inherited Kidney Disease

 

“All happy families resemble one another, each unhappy family is unhappy in its own way.“
Leo Tolstoy

Like all patients with a chronic disease, Kathy was symptomatic in her own way. With 5% kidney function, regeneration was not an expectation. She faced a sure path to dialysis, to be followed by a kidney transplant. Kathy also had neck and hip pain. Just before starting dialysis, she exercised her Right to Try AMBROSE Cell Therapy.

Kathy’s patient-reported outcome provides a look at the unique benefits a patient can have by accessing one’s adipose (fat)-derived regenerative cells (ADRCs). Said differently, just as an individual’s symptoms differ, so are the improvements that can be achieved in one’s quality of life.

Our bodies are much the same as Tolstoy describes families. When we are healthy, we enjoy exercise, sleep well, and lead active lives. In health, we are all pretty much the same.

In contrast, a group of patients diagnosed with the same disease will have symptoms unique to each in their own way:

  • Many patients diagnosed with Parkinson’s disease have tremors, but others do not.
  • Heart disease may or may not include high blood pressure, irregular heart rhythms, hardening of the arteries, chest pain, or shortness of breath.
  • Some patients have arthritis in one joint, and others have multiple joints that are stiff and painful – not to mention possible bowel or skin issues.

When we ask “Dr. Google,” What causes fatigue and dizziness? a top search result lists nine possible causes.  Thus, diagnosis is problematic. Chronic conditions include different horns (symptoms) of the same devil (diagnosis). And different devils share many of the same horns.

As the Washington Post reported, Mayo Clinic found that more than 20 percent of patients are misdiagnosed by their primary care physician (PCP). But that is not because the PCPs do not meet Mayo’s standards. They get it wrong too.

The story goes on to explain, “Diagnosis is extremely hard,” said Mark L. Graber, a senior fellow at the research institute RTI International and founder of the Society to Improve Diagnosis in Medicine. “There are 10,000 diseases and only 200 to 300 symptoms.”

Mr. Graber’s stats help explain why there are so many disease spectrums. Our symptoms and how our bodies function (physiology) vary – even if we have the same diagnosis. Adding to the complexity, some patients have few if any symptoms, while others suffer badly with the same diagnostic findings. Most vexing, the degenerative process of one disease often leads to co-morbidities.

The Epic Failure of Large Clinical Trials – Solving for the Average
Despite the uniqueness of our physical complaints, the standard of care relies on clinical trials with thousands of patients. The goal is to determine an experimental drug, device, or surgery’s safety and efficacy. That makes sense – at least on the surface. The trouble is that large trials “solve for the average,” but you are not an average patient. There is no such thing. Our unique differences in mind, body, family history, and lifestyle determine which devils and which horns with which we might suffer.

Personalized medicine is trying to solve for the individual. Here doctors:

  • Use genetic testing to help determine the risk of inheriting a disease,
  • Assess your gut for bad actors underlying a chronic condition,
  • Evaluate inflammatory markers in your blood that may lead to heart disease, diabetes, or other illnesses, and so forth.

Though that approach is promising, little benefit for large populations has resulted from extensive testing. Why? Because doctors still rely on the standard of care, rather than personalized medicines, for prescribed treatments. Without personalized drugs, doctors have no choice but to solve for the average instead of the individual.

What does this mean in the real world?
In contrast to conventional medicines, ADRCs are unique to you. They are a personalized pharmacy residing in your body. Each cell in the ADRC population is in our blood, tissues, and organs, respectively. Their purpose in the body is to keep our bodily systems – vascular, immune, endocrine, and nervous systems – as well as our tissues in balance (homeostasis).

Admittedly, we can only make assumptions about why Kathy’s quality of life improved so much from AMBROSE Cell Therapy. Our thesis is that the IV of ADRCs brought her bodily systems toward homeostasis. The mechanisms may include, along with others, a systemic reduction in chronic inflammation and abnormal immune response aided by improved blood flow. Many other good things can result from such improvements. And the direct injections initiated a process of rescue and repair in Kathy’s neck and hip.[1][2]

At the end of the day, what matters most to Kathy is the improvement in her quality of life, despite the risk that it would worsen with dialysis and a kidney transplant.

[1] B.A. Tompkins et al Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial J Gerontol A Biol Sci Med Sci, 2017, Vol. 72, No. 11, 1513–1521

[2]  S. Kesten & J.K. Fraser Autologous Adipose Derived Regenerative Cells: A Platform for Therapeutic Applications Advanced Wound Healing SURGICAL TECHNOLOGY INTERNATIONAL XXIX

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Golden Era of Self-Cell Repair

Golden Era of Self-Cell Repair

by | Sep 8, 2020 | Articles, Golden Era Articles

Golden Era of Self-Cell Repair

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.

What Are Adult Stem Cells? | AMBROSE Cell Therapy

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.

Sources of Stem Cells - Bone Marrow vs Adipose | AMBROSE Cell Therapy

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.

Adipose Tissue - Regenerative Cells (ADRCs)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

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Natural Law – Your Right to Try

Natural Law – Your Right to Try

by | May 25, 2020 | Articles, News, Patient Advocacy

Natural Law – Your Right to Try

Natural Laws are a body of unchanging moral principles derived from nature. As the basis for all human conduct, they transcend time, culture, and government. Aristotle is known as the father of Natural Law. In Rhetoric, he proposed that there is a “common law” or “higher law” that is according to nature.

The natural law framework led to the concept of “Natural Rights.” The philosopher John Locke defined Natural Rights as a person’s rights to life, liberty, and property. Locke believed that the most basic human law of nature is the preservation of humanity. To serve that purpose, he reasoned, individuals have both a right and a duty to preserve their own lives.

These principles have become universal with The Declaration of Independence (1776) of the United States, the Declaration of the Rights of Man and of the Citizen (1789) of France, the Universal Declaration of Human Rights (1948) of the United Nations as well as the European Convention on Human Rights (1953) of the Council of Europe.

The Federal Right to Try Act of 2017 is the most current way of expressing our natural right to restore our health and preserve our own lives. It gives new options to patients with life-threatening and debilitating conditions, who have failed – or are not amenable to – accepted surgeries, drugs, or devices.

Federal Right to Try Act - Ambrose Cell Therapy

There are a surprising number of adults living with complex chronic degenerative conditions, particularly those with multiple diseases (morbidities).

One such patient was Tony. In September 2018, he was facing multiple joint replacements and surgeries due to debilitating chronic inflammation and osteoarthritis in his knees, left hip, both shoulders, and fingers. Instead of operations or drugs, he exercised his ‘Right to Try” AMBROSE Cell Therapy. Now over a year and a half out, Tony is pleased to report his remarkable improvement in pain scores, mobility, function, and quality of life. Here is his inspiring Patient Reported Outcome.