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A Golden Era of Cell-Assisted Resilience

A Golden Era of Cell-Assisted Resilience

A Golden Era of Cell-Assisted Resilience

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.”

RJ’s Story
RJ played baseball, football, snowboarding, and golf growing up.

“I had some concussions and whiplash from football and a few car accidents along the way.”

RJ’s shoulder issues started in high school. Initially, his doctor thought it was bicep tendonitis. “I had to take a month off every year. It never felt good.”

One issue led to another. “When I was 17, I blew out my left knee running second base. After that, it would give out a lot.” The MRI showed his femur had lengthened, but it had never bothered RJ before the spill.

RJ’s orthopedic surgeon shaved the femur down and cleaned up the knee. “After the surgery, I did P.T. My knee felt better. I could run but couldn’t walk downhill or stairs.”

Jumping ahead, before his AMBROSE Cell Therapy, RJ complained of left knee pain, clicking, and inability to walk downstairs or a hill. His right knee was symptomatic from compensating. “I could run, but it hurt,” he later said.

Resuming RJ’s story: “I went back to playing baseball. My shoulder gave out after the first couple of days.”

“Nothing showed up on my MRI and X-Ray, but I couldn’t move my arm. I went in for exploratory surgery. The surgeon found my rotator cuff and labrum were shredded.

He repaired it, but then every season, it would give out”, RJ recounted.

Doctors refer to the shoulder joint’s major tendons as the rotator cuff. Rotator cuff tears are common injuries. Advances in surgery have improved rotator cuff repairs. But failure rates remain high.

Here, RJ’s massive rotator cuff tear (MRCT) caused disability and pain. An MRCT precipitates a Spiral of Degeneration beginning with inflammation, abnormal immune response, and lack of blood flow. That leads to programmed cell death (apoptosis), scarring, and degeneration.

Unknown to many people and a key reason shoulder surgeries have such a high failure rate, the muscle around the rotator cuff shrinks, and the body replaces it with fatty tissue.

When the tendon and muscle are finally reattached surgically to the shoulder bone, the weakened muscle can’t handle everyday stresses, and the area can be re-injured.

“I tore my rotator cuff and labrum twice more, each followed by another surgery. Both surgeries failed. In between, I ripped a hamstring, broke some fingers, and fractured my hand while stealing second base,” he said.

Cortisone injections, PRP, and physical therapy failed to bring lasting relief.

In his senior year in college and after the last surgery, his baseball coach discouraged RJ from returning to the team.

Allostatic Load and Anti-resilience.
Sterling and Eyer introduced the concept of allostasis in 1988 as stability through change. From the Greek állos, “other,” “different” + stasis, “standing still.” The researchers were imparting the concept of “remaining stable by being variable.”.

Just as a sailor keeps his boat on an even keel despite choppy waters, the body’s biological systems maintain their equilibrium (homeostasis), despite being put through stress.

In contrast, allostatic Load is “the wear and tear on the body” accumulated from repeated or chronic stress. (Bruce McEwen and Eliot Stellar 1993) Sailing across tall breaking waves over and over can cause irreparable damage.

After RJ’s sports injuries, concussions, surgeries, and competitive stress, his physiologic systems were striking out. He descended from an elite baseball player to being told by his college coach that the disabled list was not a viable option.

By age 23, RJ experienced debilitating symptoms beyond losing his ability to throw with his right arm and run the bases. He stopped bouncing back. In other words, allostatic load set in.

Baseline
RJ’s constellation of wear and tear complaints included:

  • Right shoulder pain, decreased mobility, and left shoulder stiffness.
  • Right elbow stiff, made clicking noises, left elbow stiffness though no pain, no clicking
  • Bilateral arms, decreased reflexes with hammer exam
  • Right knee, sharp pain with walking, early knee fatigue with running, aches in cold weather.
  • Left knee clicking, popping, and stiffness from compensating
  • Challenging to walk downstairs or declines.
  • Lower neck – intermittent numbness and radiation of numbness and tingling into the arm
  • Right upper arm, numbness near upper biceps insertion, constant
  • Right upper arm to fingers (middle & ring fingers), tingling, intermittent nerve pain

More concerning, RJ experienced symptoms of multisystem dysregulation:

  • Vertigo, when looking rapidly with turning his head
  • Daily headaches
  • Sleeping 15 hours per day,
  • Waking up drenched from night sweats
  • Depression
  • An extreme tendency to fall asleep (narcolepsy)
  • Chronic fatigue

In short, allostatic load was ahead 3-2 with the bases loaded in the bottom of the 9th inning. The odds were stacked against RJ Surgeries and drugs had failed him. Though recommended, RJ had the good sense of avoiding pain meds and psychotropic drugs such as Prozac, which could have worsened matters.

Fortunately, RJ had the Right to Try AMBROSE Cell Therapy.

ADRC-assisted Resilience
Based on abundant literature, AMBROSE hypothesized that ADRC-based therapy could unburden allostatic load.[1] [2] [3]  [4] [5] [6] [7]  [8] [9] [10] [11]

Further, preeminent researchers from the Texas Heart Institute, University of Tokyo, Cedar-Sinai, and other respected institutions have published studies that support ADRCs’ potential to treat multiple chronic conditions. [12] [13] [14] [15] [16]

The medical team personalized the AMBROSE Master Protocol to address RJ’s unique health challenges.

  1. Fat Harvesting
    Using minimally traumatic water-assisted liposuction technology (WAL), AMBROSE’s board-certified plastic surgeon harvested 580 ccs (19 oz) of adipose tissue. Post-procedure, RJ reported using only Tylenol for a few days.
  1. Spine and Joint Injections
    AMBROSE relied on published research in addressing the patient’s cervical spine and diseased joints with PRP-enriched micronized fat injections. [17] [18] [19] [20] [21] [22] [23]

AMBROSE’s fellowship-trained interventional pain specialist delivered 61 precise injections under real-time ultrasound guidance into RJs:

  • Inflamed cervical spine (22 injections)
  • Arthritic shoulders and bicep tendons (8 injections),
  • Sore elbows (3 injections)
  • Painful, clicking knees (18 injections).

Results
Seven months out, RJ is playing golf, swinging the baseball bat again, running, walking down declines, lifting weights, and coaching high school football and baseball.

As a result of compensating for his bum shoulder, his right elbow became his biggest problem. “My arm feels really good now- no pain, clicking, or stiffness.” He is throwing the baseball again, though, taking his time to rebuild his deconditioned shoulder muscle.

After his knee surgery, his knees deteriorated. He says, “Running is no problem now; The sharp pain and stiffness are gone. I can walk downstairs and hills again. My friends don’t laugh at me anymore.”

“My neck is much better. I don’t have the numbness and tingling. I don’t get dizzy when I turn it to the side. I haven’t recovered full range of motion yet – but that is getting better too.”, RJ added

  1. ADRC-IV Infusion
    RJ received 129 million Celution™ system processed ADRCs with 92% cell viability through IV infusion.

Published research has established that the ADRC-IV infusion reduces neuroinflammation, improves blood flow, restores autonomic nervous system function, and so on. RJ’s real-world results validate the cited studies. [24] [25] [26]

As an aside, our group’s research revealed the Celution system significantly outperforms the Medikhan, Tissue Genesis Icellator, and other commercially available adipose cell processing systems.[27] [28]

IV Results
In line with the cited publications (and others), RJ started feeling better not long after his AMBROSE treatment.

“I don’t feel depressed like I did before. I am optimistic and have more energy. I don’t wake up drenched with sweat and only need about eight hours of sleep now. I used to sleep from 12:00 am to 2:00 pm and take an hour nap too. Now I coach baseball and football 15 hours a day.”, RJ reported.

He went back to the gym, resumed light weightlifting, and lost 15 lbs. – with no change in diet. RJ added, “I haven’t been in this good of shape for at least two years,”

RJ’s benefits signal a reduction in allostatic load and restoration of multisystem homeostasis.

 

RJ is not alone.
Research studies have established a direct link between increasing allostatic Load and all-cause mortality. Unsurprisingly, studies have also connected heart disease, diabetes, kidney disease, lung disease, and so on with allostatic Load. Thus, beyond RJ’s poor health, he was at high risk of getting worse at a young age. [29]

Today’s environmental, psychological, and lifestyle factors are accelerating the time-to-allostatic Load:

Conclusion
 “The doctors and surgery center team were the best I have had. My future has gone from bleak to bright. I appreciate Matt Feshbach, AMBROSE CEO, for his follow-up and friendship. For me, AMBROSE was a grand slam.”, RJ concluded.

[1] Ghachem, A., Fried, L.P., Legault, V. et al. Evidence from two cohorts for the frailty syndrome as an emergent state of parallel dysregulation in multiple physiological systems. Biogerontology 22, 63–79 (2021).

[2] Gross, Alden L et al. “Derivation of a measure of physiological multisystem dysregulation: Results from WHAS and health ABC.” Mechanisms of ageing and development vol. 188 (2020): 111258.

[3] Guidi J, Lucente M, Sonino N, Fava G, A: Allostatic Load and Its Impact on Health: A Systematic Review. Psychother Psychosom 2021;90:11-27.

[4] Hirose 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 Cytotherapy, 2018; 20: 589–591

[5] VL Negenborn et al. Autologous Fat Grafting as a Last Resort for Unsustainable Pain in a Woman with Multiple Osteochondromas Archives of Plastic Surgery Vol. 44 No. 2 March 2017

[6] S Tamburino et al The Role of Nanofat Grafting in Vulvar Lichen Sclerosus: A Preliminary Report Arch Plast Surg 2016;43:93-95

[7] H Riyat et al Autologous fat grafting for scars, healing and pain: a review Scars, Burns & Healing Volume 3: 1–

[8] 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

[9] 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

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

[11] F Caviggioli, M.D. Autologous Fat Graft in Postmastectomy Pain Syndrome Plastic and Reconstructive Surgery August 2011

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

[13] 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

[14] Guo J et al. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 180e188

[15] Al-Ghadban S, Artiles M, Bunnell BA. Adipose Stem Cells in Regenerative Medicine: Looking Forward. Front Bioeng Biotechnol. 2022; 9:837464. Published 2022 Jan 13.

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

[17] Ibrahim, Samir, Rybacka-Mossakowska, Joanna and Michalak, Sławomir. “Fat graft – the natural choice for reconstructive, regenerative and aesthetic surgery” Medical Journal of Cell Biology, vol.5, no.2, 2017, pp.113-117. https://doi.org/10.1515/acb-2017-0008

[18] Heather Vinet-Jones*,1 & Kevin F Darr Clinical use of autologous micro-fragmented fat progressively restores pain and function in shoulder osteoarthritis Regen.Med. (2020) 15(10), 2153–2161

[19] Striano Rd, Malanga G, Bilbool N, Azatullah K. Refractory shoulder pain with osteoarthritis, and rotator cuff tear, treated with micro-fragmented adipose tissue. J. Orthopaedics Spine Sports Med. 2(1), 14–19 (2018).

[20] Lädermann A, Denard PJ, Burkhart SS. Management of failed rotator cuff repair: a systematic review. J ISAKOS. 2016;1(1):32-37. doi:10.1136/jisakos-2015-000027

[21] Heather Vinet-Jones & Kevin F Darr Clinical use of autologous micro-fragmented fat progressively restores pain and function in shoulder osteoarthritis Future Medicine Ltd Regenerative Medicine Volume 15, Issue 10, October 2020, Pages 2153-2161

[22] D.M. Robinson, C. Eng, M. Mitchkash, A.S. Tenforde, J. Borg-Stein Outcomes after Micronized Fat Adipose Transfer for Glenohumeral Joint Arthritis and Rotator Cuff Pathology: a Case Series of 18 Shoulders Muscles, Ligaments and Tendons Journal 2020;10 (3)

[23] Itro, A. et al. Why Use Adipose-Derived Mesenchymal Stem Cells in Tendinopathic Patients: A Systematic Review. Pharmaceutics 2022, 14, 1151.

[24] J Rosenstein, J Krum & C Ruhrberg VEGF in the nervous system Organogenesis 6:2, 107-114; April/May/June 2010; © 2010 Landes Bioscience

[25] 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 

[26] J. Vaquero et al Progressive increase in brain glucose metabolism after intrathecal administration of autologous mesenchymal stromal cells in patients with diffuse axonal injury Cytotherapy, 2018; 20: 806–819

[27] A Caplan PhD Mesenchymal Stem Cells J Orthop Res, Vol. 9, No. 5, 1991

[28] Skok M. Mesenchymal stem cells as a potential therapeutic tool to cure cognitive impairment caused by neuroinflammation. World J Stem Cells 2021; 13(8): 1072-1083

[29] P.G. Shiels et al. Circulating markers of ageing and allostatic load: A slow train coming Practical Laboratory Medicine 7 (2017) 49–5451

AMBROSE Cell Therapy

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A Golden Era of Cell-Assisted Spine Care

A Golden Era of Cell-Assisted Spine Care

A Golden Era of Cell-Assisted Spine Care

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

AMBROSE Cell Therapy

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Celution™ System Peer-Reviewed Papers

Celution™ System Peer-Reviewed Papers

Celution™ System Peer-Reviewed Papers

Cytori Citations

Akita, S., et al. “Autologous Adipose-Derived Regenerative Cells Are Effective for Chronic Intractable Radiation Injuries.” Radiation Protection Dosimetry, vol. 151, no. 4, 2012, pp. 656–660., https://doi.org/10.1093/rpd/ncs176.

Andjelkov, Katarina, and Zoran Maricic. “Posterior Fourchette Fissure Resolution after Injection of Autologous Adipose-Derived Regenerative Cells.” Obstetrics & Gynecology, vol. 129, no. 3, 2017, pp. 497–499., https://doi.org/10.1097/aog.0000000000001906.

Arkoulis, Nikolaos, et al. “Stem Cell Enriched Dermal Substitutes for the Treatment of Late Burn Contractures in Patients with Major Burns.” Burns, vol. 44, no. 3, 2018, pp. 724–726., https://doi.org/10.1016/j.burns.2017.09.026.

Aronowitz, Joel A., and Joshua D.I. Ellenhorn. “Adipose Stromal Vascular Fraction Isolation: A Head-to-Head Comparison of Four Commercial Cell Separation Systems.” Plastic and Reconstructive Surgery, vol. 132, 2013, p. 48., https://doi.org/10.1097/01.prs.0000435915.06075.66.

C. Calabrese, A. Kothari, S. Badylak, G. Di Taranto, M. Marcasciano, et al. Oncological safety of stromal vascular fraction enriched fat grafting in two-stage breast reconstruction after nipple sparing mastectomy: long-term results of a prospective study Eur Rev Med Pharmacol Sci. 2018 Aug;22(15):4768-4777. doi: 10.26355/eurrev_201808_15610. PMID: 30070312.

Calcagni, Maurizio, et al. “The Novel Treatment of SVF-Enriched Fat Grafting for Painful End-Neuromas of Superficial Radial Nerve.” Microsurgery, vol. 38, no. 3, 2016, pp. 264–269., https://doi.org/10.1002/micr.30122.

Cervelli, Valerio, et al. “Application of Enhanced Stromal Vascular Fraction and Fat Grafting Mixed with PRP in Post-Traumatic Lower Extremity Ulcers.” Stem Cell Research, vol. 6, no. 2, 2011, pp. 103–111., https://doi.org/10.1016/j.scr.2010.11.003.

Choi, Jae Young, et al. “Adipose-Derived Regenerative Cell Injection Therapy for Postprostatectomy Incontinence: A Phase I Clinical Study.” Yonsei Medical Journal, vol. 57, no. 5, 2016, p. 1152., https://doi.org/10.3349/ymj.2016.57.5.1152.

Daumas, A., et al. “Long-Term Follow-up after Autologous Adipose-Derived Stromal Vascular Fraction Injection into Fingers in Systemic Sclerosis Patients.” Current Research in Translational Medicine, vol. 65, no. 1, 2017, pp. 40–43., https://doi.org/10.1016/j.retram.2016.10.006.

Foubert, P, et al. “ ADIPOSE-DERIVED REGENERATIVE CELLS PROMOTE PROLIFERATION OF CORNEAL EPITHELIAL CELL AND CORNEAL WOUND HEALING.” Cytori Therapeutics.

Foubert, Philippe, et al. “Autologous Adipose-Derived Regenerative Cell Therapy Modulates Development of Hypertrophic Scarring in a Red Duroc Porcine Model.” Stem Cell Research & Therapy, vol. 8, no. 1, 2017, https://doi.org/10.1186/s13287-017-0704-1.

Foubert, Philippe, et al. “Preclinical Assessment of Safety and Efficacy of Intravenous Delivery of Autologous Adipose-Derived Regenerative Cells (ADRCs) in the Treatment of Severe Thermal Burns Using a Porcine Model.” Burns, vol. 44, no. 6, 2018, pp. 1531–1542., https://doi.org/10.1016/j.burns.2018.05.006.

François, Pauline, et al. “Development and Validation of a Fully GMP-Compliant Process for Manufacturing Stromal Vascular Fraction: A Cost-Effective Alternative to Automated Methods.” Cells, vol. 9, no. 10, 2020, p. 2158., https://doi.org/10.3390/cells9102158.

Fraser, John K., et al. “The Celution®System: Automated Processing of Adipose-Derived Regenerative Cells in a Functionally Closed System.” Advances in Wound Care, vol. 3, no. 1, 2014, pp. 38–45., https://doi.org/10.1089/wound.2012.0408.

Gentile, Pietro, et al. “Breast Reconstruction with Enhanced Stromal Vascular Fraction Fat Grafting.” Plastic and Reconstructive Surgery – Global Open, vol. 3, no. 6, 2015, https://doi.org/10.1097/gox.0000000000000285.

Gentile, Pietro, et al. “Characteristics and Potentiality of Human Adipose-Derived Stem Cells (Hascs) Obtained from Enzymatic Digestion of Fat Graft.” Cells, vol. 8, no. 3, 2019, p. 282., https://doi.org/10.3390/cells8030282.

Gotoh, M, et al. “LONG – TERM DURABILITY OF EFFICACY AND SAFETY OF REGENERATIVE TREATMENT OF MALE STRESS URINARY INCONTINENCE USING AUTOLOGOUS ADIPOSE – DERIVED REGENERATIVE CELLS.” Urology Department, Nagoya University Graduate School of Medicine.

Granel, Brigitte, et al. “Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-Derived Stromal Vascular Fraction in the Fingers of Patients with Systemic Sclerosis: An Open-Label Phase I Trial.” Annals of the Rheumatic Diseases, vol. 74, no. 12, 2014, pp. 2175–2182., https://doi.org/10.1136/annrheumdis-2014-205681.

Guillaume-Jugnot, Perrine, et al. “Autologous Adipose-Derived Stromal Vascular Fraction in Patients with Systemic Sclerosis: 12-Month Follow-Up.” Rheumatology, vol. 55, no. 2, 2015, pp. 301–306., https://doi.org/10.1093/rheumatology/kev323.

Guillo, L., Grimaud, F., Houser, F. et al. Three-year outcome of local injection of autologous stromal vascular fraction cells and microfat in refractory perianal fistulas of Crohn’s disease. Stem Cell Res Ther 13, 67 (2022). https://doi.org/10.1186/s13287-022-02738-x

Haahr, Martha Kirstine, et al. “A 12-Month Follow-up after a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial.” Urology, vol. 121, 2018, https://doi.org/10.1016/j.urology.2018.06.018.

Hao, Changning, et al. “Therapeutic Angiogenesis by Autologous Adipose-Derived Regenerative Cells: Comparison with Bone Marrow Mononuclear Cells.” American Journal of Physiology-Heart and Circulatory Physiology, vol. 307, no. 6, 2014, https://doi.org/10.1152/ajpheart.00310.2014.

Saxer, F et al. Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study. Stem Cells. 2016 Dec;34(12):2956-2966. doi: 10.1002/stem.2478. Epub 2016 Sep 16. PMID: 27538760.

Herold, C, et al. “Supplementation of Fat Grafts with Adipose-Derived Regenerative Cells in Reconstructive Surgery.” GMS German Plastic, Reconstructive and Aesthetic Surgery, vol. 2, no. ISSN 2 1 93-7052, 2012.

Hirose, Yujiro, 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.” Cytotherapy, vol. 20, no. 4, 2018, pp. 589–591., https://doi.org/10.1016/j.jcyt.2018.02.001.

Itose, Masakatsu, et al. “Knee meniscus regeneration using autogenous injection of uncultured adipose tissue-derived regenerative cells.” Regenerative Therapy 21 (2022): 398-405.

Jørgensen, Mads Gustaf, et al. “Adipose-Derived Regenerative Cells and Lipotransfer in Alleviating Breast Cancer-Related Lymphedema: An Open-Label Phase I Trial with 4 Years of Follow-Up.” Stem Cells Translational Medicine, vol. 10, no. 6, 2021, pp. 844–854., https://doi.org/10.1002/sctm.20-0394.

Kaita, Yasuhiko, et al. “Sufficient Therapeutic Effect of Cryopreserved Frozen Adipose-Derived Regenerative Cells on Burn Wounds.” Regenerative Therapy, vol. 10, 2019, pp. 92–103., https://doi.org/10.1016/j.reth.2019.01.001.

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Kuzma-Kozakiewicz, Magdalena, et al. “Intraspinal Transplantation of the Adipose Tissue-Derived Regenerative Cells in Amyotrophic Lateral Sclerosis in Accordance with the Current Experts’ Recommendations: Choosing Optimal Monitoring Tools.” Stem Cells International, vol. 2018, 2018, pp. 1–16., https://doi.org/10.1155/2018/4392017.

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Shimizu, Shinobu, et al. “Design of a Single-Arm Clinical Trial of Regenerative Therapy by Periurethral Injection of Adipose-Derived Regenerative Cells for Male Stress Urinary Incontinence in Japan: The ADRESU Study Protocol.” BMC Urology, vol. 17, no. 1, 2017, https://doi.org/10.1186/s12894-017-0282-7.

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Shimizu, Yuuki, et al. “Rationale and Design of Therapeutic Angiogenesis by Cell Transplantation Using Adipose-Derived Regenerative Cells in Patients with Critical Limb Ischemia ― Tact-ADRC Multicenter Trial ―.” Circulation Reports, vol. 2, no. 9, 2020, pp. 531–535., https://doi.org/10.1253/circrep.cr-20-0055.

Shimizu, Yuuki, et al. “Therapeutic Angiogenesis for Patients with No-Option Critical Limb Ischemia by Adipose-Derived Regenerative Cells: Tact-ADRC Multicenter Trial.” Angiogenesis, vol. 25, no. 4, 2022, pp. 535–546., https://doi.org/10.1007/s10456-022-09844-7.

Shimizu, Yuuki, et al. “Therapeutic Lymphangiogenesis with Implantation of Adipose‐Derived Regenerative Cells.” Journal of the American Heart Association, vol. 1, no. 4, 2012, https://doi.org/10.1161/jaha.112.000877.

Suzuki, Junya, et al. “No Influence on Tumor Growth by Intramuscular Injection of Adipose-Derived Regenerative Cells: Safety Evaluation of Therapeutic Angiogenesis with Cell Therapy.” American Journal of Physiology-Heart and Circulatory Physiology, vol. 320, no. 1, 2021, https://doi.org/10.1152/ajpheart.00564.2020.

Szczepanik, Elzbieta, et al. “Intrathecal Infusion of Autologous Adipose-Derived Regenerative Cells in Autoimmune Refractory Epilepsy: Evaluation of Safety and Efficacy.” Stem Cells International, vol. 2020, 2020, pp. 1–16., https://doi.org/10.1155/2020/7104243.

Tsekouras, Anastasios, et al. “Adipose-Derived Stem Cells for Breast Reconstruction after Breast Surgery – Preliminary Results.” Case Reports in Plastic Surgery and Hand Surgery, vol. 4, no. 1, 2017, pp. 35–41., https://doi.org/10.1080/23320885.2017.1316201.

Tsubosaka, Masanori, et al. “The Influence of Adipose-Derived Stromal Vascular Fraction Cells on the Treatment of Knee Osteoarthritis.” BMC Musculoskeletal Disorders, vol. 21, no. 207, 2020, https://doi.org/10.21203/rs.2.21422/v1.

Yamaguchi, Shukuro, et al. “Adipose-Derived Regenerative Cells as a Promising Therapy for Cardiovascular Diseases: an Overview.” Nagoya J. Med. Sci, vol. 84, 2022, pp. 208–215.

Yoshimura, Kotaro, et al. “Cell-Assisted Lipotransfer for Cosmetic Breast Augmentation: Supportive Use of Adipose-Derived Stem/Stromal Cells.” Aesthetic Plastic Surgery, vol. 44, no. 4, 2020, pp. 1258–1265., https://doi.org/10.1007/s00266-020-01819-7.

Yoshimura, Kotaro. “Cell-Assisted Lipotransfer and Therapeutic Use of Adipose Stem Cells Thereafter.” Aesthetic Plastic Surgery, vol. 44, no. 4, 2020, pp. 1266–1267., https://doi.org/10.1007/s00266-020-01781-4.

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Akita, Sadanori, et al. “Noncultured Autologous Adipose-Derived Stem Cells Therapy for Chronic Radiation Injury.” Stem Cells International, vol. 2010, 2010, pp. 1–8., doi:10.4061/2010/532704.

Albersen, Maarten, and Trinity J. Bivalacqua. “Regenerative Medicine for Erectile Dysfunction Following Radical Prostatectomy: Are We Ready?” EBioMedicine, vol. 5, 2016, pp. 28–29., doi:10.1016/j.ebiom.2016.02.033.

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Borowski, David W., et al. “Adipose Tissue–Derived Regenerative Cell–Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano.” Surgical Innovation, vol. 22, no. 6, 2015, pp. 593–600., doi:10.1177/1553350615572656.

Foubert, Philippe, et al. “Adipose-Derived Regenerative Cell Therapy for Burn Wound Healing: A Comparison of Two Delivery Methods.” Advances in Wound Care, vol. 5, no. 7, 2016, pp. 288–298., doi:10.1089/wound.2015.0672.

Foubert, Philippe, et al. “Uncultured Adipose-Derived Regenerative Cells (Adrcs) Seeded in Collagen Scaffold Improves Dermal Regeneration, Enhancing Early Vascularization and Structural Organization Following Thermal Burns.” Burns, vol. 41, no. 7, 2015, pp. 1504–1516., doi:10.1016/j.burns.2015.05.004.

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Haahr, Martha Kirstine, et al. “Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial.” EBioMedicine, vol. 5, 2016, pp. 204–210., doi:10.1016/j.ebiom.2016.01.024.

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AMBROSE Cell Therapy

Your Right to Try

A Golden Era of Cell-Assisted Brain Care Ahead

A Golden Era of Cell-Assisted Brain Care Ahead

A Golden Era of Cell-Assisted Brain Care Ahead

Muhammed Ali’s 1960 Olympic Gold medal started his ascent to being “The Greatest,” but the countless blows to his head – which he welcomed to tire his opponent out – ended in a years-long failed fight to save his brain.

In 2016, Parkinson-related issues took his life, though not before he sought out adult stem cell therapy. Unfortunately, Congress had not yet passed the Federal Right to Try Act of 2017.

What if those who first observed Ali’s slurring, shuffling, and memory struggles had known about the healing factors adipose-derived stem and regenerative cells (ADRCs) secrete?
And what if Ali had the Right to Try to access his ADRCs?

Would he have resumed floating like a butterfly and stinging like a bee? No, but that’s not the point, either.

Ali would have had a fighting chance at a better quality of life. Instead, he faced a decades-long struggle with his Parkinson’s symptoms and the PD drug’s side effects of nausea and tremors, not to mention the other medical conditions with which he lived.

Ali’s descent is a stark example of the risks of brain injuries to our long-term brain health.[1] And these risks are not unique to him or boxing.

Tim’s Win
“I raced in hundreds of powerboat races. Maybe I’m lucky…maybe I’m blessed…maybe I’m genetically superior…or maybe I’m all three, with help from my ADRCs!” says Tim.

In 2000, Tim retired from offshore powerboat racing with four world speed records. He once hit upwards of 180 mph.

Arguably more at risk than Ali, he suffered innumerable head traumas, lost consciousness, and survived a near-death coma on the way to winning his Gold Medals.

In the early 2000s, Tim’s family and friends noticed his hands shaking. In 2008, a neurologist diagnosed him with essential tremors.

Essential tremor is a nervous system (neurological) disorder that causes involuntary and rhythmic shaking. It can affect almost any part of your body, but the trembling occurs most often in your hands — especially when you do simple tasks, such as drinking from a glass, handwriting, or tying shoelaces.

“The cause was a breakdown in the electrical connections in the nervous system due to adverse trauma,” Tim’s neuro explained. He forecasted continued deterioration.

Essential tremors are a suspected risk factor for Parkinson’s disease.[2] And as discussed in detail below, concussions significantly increase the risk of Alzheimer’s, Parkinson’s, ALS, and other neurodegenerative disorders.

Tim’s powerboat racing magnified the risk from contact sports. “It’s been determined that offshore race boat drivers experience more G forces in one race than all the astronauts in the history of NASA have experienced put together. The impact would come up your spine. My head would wobble like a bobble doll,” Tim explained.

“I must have had 1,000 concussions while racing. I probably went unconscious 100 times behind the wheel from the G-forces,” Tim estimated.

Before Tim had the “need for speed,” he played high school and college football. “This was in the days long-before helmet-on-helmet rules, and concussion protocols were in place. I remember getting hit in the head, going to the wrong sideline, and being put right back out on the field”, he recalled.

Tim also tells about his near-catastrophic motorcycle accident when he was a teen: “No helmet, of course…in the hospital for ten days…coma, severe concussion.”

Tim’s Right to Try
In March 2016, Tim accessed his ADRCs offshore with AMBROSE’s prior group. (Okyanos Cell Therapy, Freeport, Bahamas). Almost seven years later, he said, “I should be in much worse shape than I am.”

“My tremors are barely noticeable to other people now. I can eat soup without losing 2/3s of it between the bowl and my mouth. My writing isn’t perfect like I learned in Catholic school growing up, but I can sign checks and write legibly. My memory is fine.”

“The benefit of the stem cells is that it reconnected the wiring,” said Tim.

Tim credits his ADRCs-based cell therapy with other unexpected benefits:

  • “I wore glasses when I raced and before my treatment. Afterward, my vision improved to 20/20. I no longer wear glasses, including readers.” Tim is 63 years young.
  • After all the pounding on my ears and brain from racing and playing the drums in high school, I expected to be deaf by now.” he half-joked. “Instead, my hearing, senses of smell, and taste are better than they were before.”

Remarkably, Tim only recently developed high blood pressure and has no joint or spine issues.

Given Tim’s baseline and absence of other interventions, it would be difficult to attribute his sustained six-year improvement to anything other than his ADRC-based treatment.

Thus, we foresee a Golden Era of Brain Care ahead. More on that in a moment; first, some background.

Background
In the late 1970s, boxing fans observed changes in Muhammed Ali’s speed and speech. Others noted that Ali seemed bored and emotionally detached. The Greatest estimated his opponents hit him in the head 29,000 times – that is like being whacked in the skull day in and day out for 79 years.

And even in fights that he won, Ali took some vicious beatings, especially later in his career. He described the epic third fight with Joe Frazier, in which Ali retained his title after 14 brutal rounds, as “the next thing to death.”

In 1984, three years after retiring from the ring, Ali was diagnosed with Parkinson’s Disease (PD). At that time, doctors did not link the brutal poundings with PD.

Further, TBI research did not associate Ali’s brain damage with chronic traumatic encephalopathy (CTE), the term researchers use to describe a disease of the brain (encephalopathy) caused by repeated head traumas.

Nor did his doctors connect CTE to his frequent bouts of pneumonia, infections, or dementia.

Ali’s descent is a stark example of the risks of brain injuries to our long-term brain health.[3] And these risks are not unique to him or boxing.

CTE is Pervasive
Will Smith’s movie, Concussion brought public awareness to the devastation too many football players face later in life. NFL players are paid big bucks for taking three times the risk of dying from brain disorders than the fans watching them. That risk expands to four times for Alzheimer’s and ALS, respectively.[4]

In 2017, the Journal of the American Medical Association published a study revealing bleak futures for former NFL players. Their median age of death was just 67, and out of the 111 post-mortems, 99% — were diagnosed with CTE.

CTE symptoms vary depending on how advanced or severe it is, but people may experience memory problems, mood disorders, depression, and lapses in judgment.

Brain Trauma – Adding Insult to Injury and Injury to Insult

Brain trauma can be mild or minor, severe, or significant. You don’t have to be an NFL player, a boxer, or race powerboats to increase the probability of Alzheimer’s, Parkinson’s, and other neurologic problems.

After head trauma, some victims recover right away, but many suffer from a constellation of disturbances, including fatigue, poor memory, insomnia, pain, vision, speech, and balance difficulties. [5] [6]

Going the Distance from Brain Science to Brain Care
Ali had another fight separate and apart from his Parkinson’s battle: The chasm between the known factors contributing to neurological conditions and the treatment options available to patients suffering from them.

The gap became apparent in 2006 when Dr. William Langford, the first Chief Science Officer of the Michael J. Fox Foundation, published Parkinson’s Complex: Parkinsonism Is Just the Tip of the Iceberg.[7]

In short, Dr. Langford’s seminal paper stated PD was not limited to the loss of dopamine-producing neurons in the substantia nigra. Instead, Parkinsonism involves multisystem breakdowns. Therefore, he said, “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.

Subsequently, researchers discovered the same interconnected dysregulations after a TBI, stroke, spinal cord injury, Alzheimer’s, etc. Brain diseases don’t pull any punches – they spare no physiologic system.

To solve for this, doctors prescribe patients drugs for each ailment or symptom, e.g., Sinemet for Parkinson’s, Ambien for sleep, steroids for arthritis, opioids for pain, and so forth.

Drug side effects include accelerating the decline in cognitive function.[8]
Dr. Armon Neel Jr. cautions that ten drug classes contribute to dementia progression.

Multisystem dysregulation is a chicken and egg problem. Nearly all patients with brain degeneration live with multiple chronic conditions (co-morbidities).

Tim’s ADRCs – Miracle-Gro For His Brain
Miracle-Gro feeds your garden’s soil with the nutrients it needs to grow healthy roots, stems, petals, and leaves. And just as there are situations in which we fertilize a plant lacking vital nutrients, ADRCs secrete growth factors essential to the health of our aging brains, hearts, muscles, nerves, and so on. [9]  Growth factors (GFs) are a type of cytokine or healing molecule that act on other cells to stimulate growth and function.

One such growth factor group is “Neurotrophic factors (NTFs).” Neuro relating to nerve and trophic, from Ancient Greek trophikós, meaning “of food or nourishment.” In other words, NTFs feed our neurons and nerves with nutrients.

Brain-derived neurotrophic growth (BDNF) stimulates new brain cells, brain cell connections, and nerves. It also repairs the myelin sheathing surrounding the nerves.

It gets better: BDNF is anti-inflammatory and prevents programmed cell death (apoptosis) resulting from an injury or disease. [10] [11] [12] [13] [14]

Many benefits are associated with higher levels of BDNF, including improved mood, productivity, and memory. One 10-year study that tracked BDNF levels in adults found that those with low levels were twice as likely to develop dementia and Alzheimer’s than those with the highest levels.[15]

John Hopkins researchers developed a BDNF-blood test that could have predicted the severity of Ali’s head damage and how he would fare. Their study showed that patients with brain injuries have less than one-third of the BDNF as those with healthy brains.

The most severe TBIs had even lower levels- about 5% of normal. Moreover, patients with high levels of BDNF recovered from their injuries six months later. But symptoms lingered at follow-up in patients with the lowest levels of BDNF.[16]

ADRCs also enrich the brain with vascular endothelial growth factor (VEGF). VEGF restores blood flow and reduces inflammation in withering tissues, blood vessels, and organs. One study found higher levels of VEGF in asymptomatic seniors who died with amyloid plaques compared to symptomatic Alzheimer’s patients.

Notably, ADRCs secrete dozens of other healing factors.[17]

In combination, ADRCs restore multisystem balance or homeostasis – at the cellular, tissue, organ, and multisystem levels.

By the way, big pharma can’t discover a single molecule they can sell millions of copies of per year that can restore physiologic balance. Their drugs suppress the disease’s presumed- but often wrong -causes.

Thus, we believe Ali could have benefited from accessing his ADRCs. The medical literature supports it – and so does Tim’s powerful reversal of his symptoms. If only Ali had the Right to Try. [18] [19] [20] [21] [22] [23]

[1] Ledreux A, Pryhoda MK, Gorgens K, Shelburne K, Gilmore A, Linseman DA, Fleming H, Koza LA, Campbell J, Wolff A, Kelly JP, Margittai M, Davidson BS and Granholm A-C (2020) Assessment of Long-Term Effects of Sports-Related Concussions: Biological Mechanisms and Exosomal Biomarkers. Front. Neurosci. 14:761.

[2] Tarakad A, Jankovic J. Essential Tremor and Parkinson’s Disease: Exploring the Relationship. Tremor Other Hyperkinet Mov (N Y). 2019; 8:589. Published 2019 Jan 9.

[3] Ledreux A, Pryhoda MK, Gorgens K, Shelburne K, Gilmore A, Linseman DA, Fleming H, Koza LA, Campbell J, Wolff A, Kelly JP, Margittai M, Davidson BS and Granholm A-C (2020) Assessment of Long-Term Effects of Sports-Related Concussions: Biological Mechanisms and Exosomal Biomarkers. Front. Neurosci. 14:761.

[4] Lehman EJ, Hein MJ, Baron SL, Gersic CM. Neurodegenerative causes of death among retired National Football League players. Neurology. 2012 Sept 5 [Epub ahead of print].

[5] R. Jorge et al Major Depression Following Traumatic Brain Injury Arch Gen Psychiatry/Vol 61 Jan 2004

[6] D. Nampiaparampil   Prevalence of Chronic Pain After Traumatic Brain Injury A Systematic Review. JAMA.2008;300(6):711–719.

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

[8] Ishii N et al. Polypharmacy Associated with Cognitive Decline in Newly Diagnosed Parkinson’s Disease: A Cross-Sectional Study Dement Geriatr Cogn Disord Extra 2019; 9:338–343

[9] A Caplan PhD MSCs: The Sentinel and Safe-Guards of Injury J. Cell. Physiol. 231: 1413–1416, 2016.

[10] 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.

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

[12] 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

[13] 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

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

[15] Jiao SS, Shen LL, Zhu C, et al. Brain-derived neurotrophic factor protects against tau-related neurodegeneration of Alzheimer’s disease. Transl Psychiatry. 2016;6(10):e907.

[16] FK K. Korley et al Circulating Brain-Derived Neurotrophic Factor Has Diagnostic and Prognostic Value in Traumatic Brain Injury JOURNAL OF NEUROTRAUMA 33:215–225 (January 15, 2016)

[17] Hirose, Yujiro 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 Cytotherapy, Volume 20, Issue 4, 589 – 591

[18] JK Fraser PhD and S. Kesten MD Autologous Adipose Derived Regenerative Cells: A platform for therapeutic applications Advanced Wound Healing Surgical Technology International XXIX

[19] C. Tate and C Case. Mesenchymal Stromal Cells to Treat Brain Injury. Advanced Topics in Neurological Disorders.

[20] S Dobrowolski and G Lepski. Stem Cells in Traumatic Brain Injury. American Journal of Neuroscience 4 (1): 13-24

[21]CS et al. Autologous bone marrow mononuclear cell therapy for severe traumatic brain injury in children. Neurosurgery 2011; 68: 588–600

[22] N Tajiri et al. Intravenous transplants of human adipose-derived stem cell protect the brain from traumatic brain injury-induced neurodegeneration and motor and cognitive impairments: cell graft biodistribution and soluble factors in young and aged rats. J Neurosci. 2014 Jan 1;34(1):313-26

[23] Sharma et al Cell therapy attempted as a novel approach for chronic traumatic brain injury – a pilot study SpringerPlus (2015) 4:26

AMBROSE Cell Therapy

Your Right to Try

Can something be done for Covid Long-Haulers?

Can something be done for Covid Long-Haulers?

Can something be done for Covid Long-Haulers?

After living with severe long-Covid symptoms and pre-existing health conditions, Brian exercised his Right to Try AMBROSE Cell Therapy in November 2021. He says AMBROSE has had “a massive effect on my health and quality of life.” Brian adds, nine months out, “I am doing things I couldn’t do a month ago.”

Remarkably, Brian’s many benefits occurred despite ongoing business stress and the difficult loss of two family members.

BackgroundSince December 2019, SARS coronavirus 2 (SARS-CoV-2) has spread like wildfire across the globe.  Unlike the seasonal flu or cold, COVID-19 can attack all body systems and multiple organs.

In response to the virus’ scorched earth capabilities, stem cell researchers worldwide have collaborated to improve outcomes for high-risk Covid patients and long-haulers. [1]

The researchers drew from over 200,000 published papers on Mesenchymal Stem Cells (MSCs). By July 2022, their urgency resulted in 6,400 articles or around 12 daily.

The in-human MSC studies included Covid-induced:

  • Acute respiratory distress syndrome (ARDS) [2]
  • Multisystem inflammatory syndrome in children [3]
  • Multi-organ disease, including sudden cardiac arrest [4]
  • COVID-19 pneumonia in April 2020. [5]

Dr. Pietro Gentile and others focused their research on adipose-derived stem cells (ADSCs) and ADRCs.  [6] [7] [8] [9]

Can ADRCs help Covid Long-Haulers?

Most promising for Brian, his long-Covid symptoms intersected with those from hypermobility, concussions, renal failure, Lyme Disease, and post-chemo side effects.

In response to one or more of these insults, our ADRCs secrete growth factors (GFs) and anti-inflammatory signaling proteins or cytokines essential to our brains, hearts, muscles, nerves, cells, and body health in general.

We share more on GFs and cytokines in Brian’s story that follows.

Ambrose patients Trish, Wouter, Kathy, and other patients with brain fog, fatigue, joint pain, and so on responded to ADRC-based therapy.  Therefore, it made sense for Brian to try AMBROSE Cell Therapy.

Brian’s Story
In December 2020, Brian’s doctor admitted him to the Cedar-Sinai ICU with COVID-19, returning home as a Covid long-hauler after two weeks.

After an introductory call with CEO Matt Feshbach, AMBROSE provided an educational MD consult, overview articles, and peer-reviewed papers supporting the safety and potential effectiveness of the therapy for long-Covid and the other conditions affecting him. Brian said,” (Matt) answered my questions. I had sufficient understanding to move forward.”

Covid Long-Hauler Symptoms
Brian experienced classic long-hauler symptoms: brain fog, chronic fatigue, and emotional volatility. As he summarized, “Most of 2021 was a lost year.”

He started to notice benefits shortly after his AMBROSE treatment. “After about a month, I saw a massive improvement in my mental clarity and energy. Business associates said they noticed the difference too. I didn’t realize how bad the fatigue was until I regained my strength.”

Supporting Brian’s statements, ADRCs release “Neurotrophic factors (NTFs),” Neuro relating to nerve and trophic, from Ancient Greek trophikós, meaning” of food or nourishment.”  NTFs, through multiple mechanisms, reduce neuroinflammation and stimulate the development of new brain cells, brain cell connections, and nerves. [10] [11]

Just as fertilizers keep plants healthy and growing, neurotrophic factors work like Miracle Grow for the brain.

Brian’s restored energy and mental clarity make sense in light of the above.

Vasculitis
Covid left Brian with debilitating inflamed blood vessels and swelling in both legs, or vasculitis, an autoimmune condition. He also complained of constant numbness and tingling in both legs (neuropathy). The right leg was worse than the left.

“My vasculitis and neuropathy went away shortly following the treatment.”

In addition to the NTFs, ADRCs secrete Vascular Endothelial Growth Factor (VEGF). VEGF improves circulation, reduces inflammation, and stimulates the growth of new blood vessels.

Here again, it makes sense that Brian’s swollen blood vessels and nerves calmed down. And an abundance of literature supports Brian’s subjective experience. [12] [13]

And back to Brian’s brain: VEGF reduces neuroinflammation and improves blood flow in the brain. In contrast, neuroinflammation and lack of blood flow in the brain cause chronic fatigue, brain fog, and memory issues. [14] [15]

Pre-Existing Conditions
Brian entered the hospital with a galaxy of pre-existing conditions that had failed to improve with surgeries, drugs, and devices.

Before the pandemic, Brian lived with:

  • Obesity
  • Arthritis in his lower back, shoulders, hips, and knees
  • Asthma
  • Fractured ribs
  • Osteopenia (an early stage of osteoporosis) and
  • A mildly enlarged heart and shortness of breath

In summary, Brian suffered from multisystem dysregulation.

His medications included Prednisone 30-mg daily, Singulair, Symbicort, and Spiriva for Asthma. Ambien for sleep.

Can ADRCs help Covid long-haulers with pre-existing conditions?
In 2016 The California Institute of Regenerative Medicine (CIRM) contributed funding to two review papers that supported ADRC-based treatment for Brian’s chronic illnesses. Further, preeminent researchers from Tulane University and other respected research institutions have continued the growing support for ADRCs’ potential to treat multiple diseases. [16] [17] [18]

Obesity
Brian has struggled with his weight since a young age. “I have probably lost 300 lbs. throughout my life. I tried bariatric surgery in 2007 but gained the weight back.”

“Since my treatment, I have dropped about 50 lbs. and have maintained my weight within a lower range with a less restrictive diet for the first time.”

In 1994, super-sleuth Jeffrey M. Friedman of Rockefeller University established fat as an endocrine organ. In simple terms, he discovered adipose cells secrete hormones that regulate weight gain. His insight explains Brian’s improved metabolism and fat burning following his cell therapy treatment. [19] [20]

Wear, Tear, and Trauma
Brian played football in high school, resulting in some head traumas. He was involved in several major motor vehicle accidents in his early 20s. He went unconscious twice. “They took me to the hospital several times; it was pretty bad.”

Football, basketball, baseball, skiing, and excess weight was not kind to Brian’s joints either.

  • Three right-knee operations failed, leaving both knees painful.
  • He experienced degenerative arthritis in his shoulders.
  • His right and left hips were arthritic as well.

Steroid injections in the affected joints failed to give Brian relief. He tried bone-marrow stem cell injections for his shoulders, but that “didn’t work at all.”

Ambrose’s interventional pain specialist developed a personalized treatment plan based on a Master Protocol. He delivered 22 injections of PRP-enriched micronized fat into Brian’s painful joints.

A month out, his PT said, “Brian’s weight-bearing tolerance and conditioning are improving. He’s doing great.”

Eight months out, Brian shared, “My shoulder, hips, and knees feel good. My back is fine.”

Asthma
Brian developed asthma in his 40s after spending a month in China on business. Before his stem cell treatment, he used three inhalers and took 30 mg of prednisone daily.

Nine months after Brian’s AMBROSE treatment, he says, “I have lowered my daily prednisone dose to 10 mg and occasionally miss taking it without an asthma flare. I significantly reduced my use of inhalers, too.”

Fractured Ribs
An asthma-induced coughing attack fractured four ribs on March 1, 2018. After reviewing Brian’s x-rays, his orthopedist told him he could not repair the ribs. Additionally, Brian had an underlying diagnosis of osteopenia, a condition involving reduced bone mass.

Studies showed that ADRCs stimulate bone healing. [21]

The Ambrose physician injected the fractured ribs. Several months later, Brian reported, “My ribs feel like they healed. That is impressive” To be clear, he still experiences mild discomfort, “but nothing like it was before.”

Mildly Enlarged Heart
A 2018 cardiac workup revealed Brian had a mildly enlarged heart and shortness of breath.
His cardiologist and PT agree the shortness of breath is no longer evident.

The PRECISE cardiac cell therapy study demonstrated significant improvements in endurance, thus supporting Brian’s doctor’s observations. [22] A new cardiac workup is in order.

Multisystem Balance Restored
Brian’s patient-reported outcome demonstrates the potential to restore multisystem homeostasis (balance) by utilizing his ADRCs.

Recommending AMBROSE to Family and Friends
“I have recommended Ambrose to my mother and best friend. It makes sense for them to try it too. Both have arthritic joints, back pain, and other medical issues.”

 

 

[1] Yasamineh et al. Spotlight on therapeutic efficiency of mesenchymal stem cells in viral infections with a focus on COVID-19 Stem Cell Research & Therapy (2022) 13:257
[2] Wick K et al. Mesenchymal stromal cells reduce evidence of lung injury in patients with ARDS JCI Insight 2021;6(11):e148983
[3] Ross Eckard A, Borow KM, Mack EH, Burke E, Atz AM. Remestemcel-L therapy for
COVID-19-associated multisystem inflammatory syndrome in children. Pediatrics. 2021
[4] Yilmaz R et al. Mesenchymal stem cells treatment in COVID-19 patient with multi-organ involvement Bratisl Med J 2020; 121 (12) 847-852
[5] Zeng et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia Aging & Disease Volume 11 Number 2; 216-228, April 2020
[6] Stromal Vascular Fraction or SVF is the generic term for clinical grade adipose-derived regenerative cells.
[7] Pietro Gentile, Aris Sterodimas. Adipose Stem Cells (ASCs) and Stromal Vascular Fraction (SVF) as a Potential Therapy in Combating (COVID-19)-Disease. Aging and disease. 2020, 11(3): 465-469
[8] Alexander RW. (2020) Overview of COVID-19 Lung Damage Clinical Trial Using Cellular
Stromal Vascular Fraction (cSVF) and Functional Respiratory Imaging (FRI) Analysis of Pulmonary Injury
& Post-Viral (SARS-CoV-2) Adult Respiratory Distress Syndrome (ARDS). Stem Cell Res. 1(1)-1-19.
[9] Sanchez-Guijo F et al. Adipose-derived mesenchymal stromal cells for the treatment of patients with severe SARS-CoV-2 pneumonia requiring mechanical ventilation. A proof of concept study EClinical Medicine 000 (2020) 100454
[10] 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
[11] Xu et al Brain-derived neurotrophic factor reduces inflammation and hippocampal apoptosis in experimental Streptococcus pneumoniae meningitis Journal of Neuroinflammation (2017) 14:156
[12] Liao L. Mesenchymal stem cell and hematopoietic stem cell transplantation for vasculitis. Vasc Invest Ther 2020; 3:88‐93.
[13] Jahangir S et al. New advanced therapy medicinal products in treatment of autoimmune diseases Editor(s): Nima Rezaei, In Translational Immunology, Translational Autoimmunity, Academic Press, Volume 2, 2022, Pages 319 359,
[14] Skok M. Mesenchymal stem cells as a potential therapeutic tool to cure cognitive impairment caused by neuroinflammation. World J Stem Cells 2021; 13(8): 1072-1083
[15] J Rosenstein, J Krum & C Ruhrberg VEGF in the nervous system Organogenesis 6:2, 107-114; April/May/June 2010; © 2010 Landes Bioscience
[16] 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
[17] Guo J et al. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 180e188
[18] Al-Ghadban S, Artiles M, Bunnell BA. Adipose Stem Cells in Regenerative Medicine: Looking Forward. Front Bioeng Biotechnol. 2022; 9:837464. Published 2022 Jan 13.
[19] Zhang, Y; Proenca, R; Maffei, M; Barone, M; Leopold, L; Friedman, JM (December 1994). “Positional cloning of the mouse obese gene and its human homologue”. Nature. 1994 (372): 425–432
[20] Zuccarini, M et al Adipose Stromal/Stem Cell-Derived Extracellular Vesicles: Potential Next-Generation Anti-Obesity Agents. Int. J. Mol. Sci.
2022, 23, 1543.
[21] Saxer F et al. Implantation of Stromal Vascular Fraction Progenitors At Bone Fracture Sites: From A Rat Model To A First-In-Man Study STEM CELLS 2016; 00:00-00
[22] Perin E et al., Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial Am Heart J 2014;168:88-95.e2.

AMBROSE Cell Therapy

Your Right to Try