The Stem Cell Revolution

The

Stem Cell

Revolution

Mark Berman, MD; Elliot Lander, MD

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© 2015 Mark Berman, MD; Elliot Lander, MD. All rights reserved.

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Published by AuthorHouse 10/09/2015

ISBN: 978-1-5049-2001-8 (sc)

ISBN: 978-1-5049-2000-1 (hc)

ISBN: 978-1-5049-2002-5 (e)

Library of Congress Control Number: 2015910573

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ABOUT THE COVER

In 1508, Michaelangelo Buonarroti painted this image of the creation of Adam on the ceiling of the Sistine Chapel. He not only displayed artistic genius but also possessed much knowledge as an anatomist. We now know that Michaelangelo secretly practiced his passion for anatomy at a time when the Church decreed dissection of cadavers punishable by death. He risked his career and his life in his pursuit of anatomic truth and he left us a hidden message in his juxtaposition of God with a cross section of the human brain. The image demonstrates the frontal lobe, the sulci, the hypothalamus, the brainstem, the optic chiasm, and many of the anatomic structures we first learned about in our medical school neuro-anatomy courses. American Neurologist Frank Meshberger first noted this stunning depiction of God as the supreme intelligence during an artistic epiphany while staring at the chapel ceiling nearly 500 years after it was painted. One starts to ponder what other sublime wonders lay hidden in full view. The serendipitous discovery of millions of healing stem cells programed for human repair sitting in plain view just under our skin might just be one of those wonders. We now stand at the inception of a new field of medical science. Call it regenerative science or call it the hand of God, either way, it compels the question: what is one willing to risk for the pursuit of knowledge and truth?

Elliot Lander MD

Contents

Foreword

Prologue

Chapter 1 The Science of Stem Cells

Chapter 2 Aesthetics to Therapeutics

Chapter 3 Heart of the Matter

Chapter 4 Just Breathe

Chapter 5 Staying in the Game

Chapter 6 The Harder they Come

Chapter 7 Walk On

Chapter 8 Vision Quest

Chapter 9 Go with Your Gut

Chapter 10 Confronting our Critics

Epilogue

End Note

Acknowledgments

Addendum

References

Foreword

In his bestselling 2007 book The Black Swan, author Nassim Taleb describes uncertainty and randomness and how we routinely underestimate huge deviations from what we expect to happen. Taleb’s book weaves together philosophy, math, history, and business to explain the huge impact of highly unpredictable and improbable Black Swan events.

The serendipitous finding of high numbers of regenerative stem cells in the fatty tissue just under our skin – and the simple use of minor, low-risk surgical procedures and FDA-approved enzymes to release and deploy them to help heal our body’s damaged tissues – combine to produce a truly extraordinary Black Swan event wherein every patient can be his or her own bio-factory for regenerative medicine. One might call it Regenaceutical as opposed to Pharmaceutical.

How all this will impact the medical world of cell therapy, the academic world of pathways and patents, and the pharmaceutical industry, is still unclear – but the effects have already started and taken hold. That’s why we call our project the Stem Cell Revolution®.

Mark Berman, MD and Elliot Lander, MD

Founders: California Stem Cell Treatment Center and the Cell Surgical Network

Prologue

We have entered the rapidly evolving stem cell age. The media saturates us with stories, hype and promises about stem cell wonders and cures. As clinicians, we witnessed the initial achievements in cell therapy unlocking the potential for actual organ repair and replacement. While academia and industry may eventually provide pharmaceutical stem cells in a bottle, there already exists an alternative clinical industry of stem cell treatment clinics offering cell therapies derived from adult tissues – particularly adipose tissue. These centers offer patients treatment options that they cannot obtain in many traditional doctors’ offices or large trials. In the US, same day surgical procedures permit physicians to transfer tissues rich in stem cells to damaged areas of the body providing patients access to regenerative therapies now. Same day surgical procedures that maintain sterility without risk of disease transmission support the very mission of the current FDA tissue handling rules. Thus, stem cells found in autologous fat, extracted through a safe and near painless procedure afford such clinics the opportunity to help countless patients now.

In 2008, colleagues in Asia provided Dr. Mark Berman, an internationally recognized expert on fat grafting procedures, an improved way to harvest and process fat for grafting. Further, they had developed a method to procure stromal vascular fraction (SVF – rich in mesenchymal stem cells) from fat. Once safe enzyme materials were available, we modified the technique to produce a closed sterile surgical method for producing SVF. We quickly realized that we had valuable technology at our disposal but that we would have to use it judiciously. From the start, we created the California Stem Cell Treatment Center®, a multispecialty team necessary for treating conditions beyond our scope of practice such orthopedic, cardio/pulmonary, urologic and other diseases. We set up safety studies for the investigational use of SVF and obtained Institutional Review Board (IRB) approval for them. We built an educational website www.stemcellrevolution.com that explains the nature of this patient funded research. We coined the term "cell surgery" since our surgical procedure has no laboratory component thus distinguishing ourselves from the pharmaceutical model. We have now performed over 2000 cases demonstrating extraordinary safety and no serious adverse effects related to SVF deployment. We have seen astonishing results in tissue healing, autoimmune and neurodegenerative disease mitigation, arthritis mitigation and treatment of crippling back pain. The uses and various methods of deploying SVF are continually growing.

Understanding the importance and necessity of teaching our technology to other interested physicians, we formed the Cell Surgical Network®(CSN) in 2012 and started training select physicians in our regenerative medicine techniques. CSN® now includes 79 centers around the world. All Network physicians are performing cell surgery using identical methods and protocols and all are collecting safety and outcomes data in our online database. Our safety study for the first 1000 patients is in manuscript form.

Considered a disruptive technology, point of care production and deployment of SVF allows surgeons to tap the human storehouse of healing cells, making them bio-available for disease mitigation. The Cell Surgical Network® mission is to accelerate the quality of regenerative medicine and have safe and cost effective cell based therapies available soon to everyone in the world. A vision we get closer to achieving every day.

Elliot Lander MD and Mark Berman MD

Chapter 1

The Science of Stem Cells

Stem cell: an unspecialized cell that can differentiate (i.e. change into) a specific specialized cell; also has the capability to replicate.

The mention of stem cells raises tremendous controversy, such that the American public tends to presume two things: 1) That the cells in question are embryonic cells, harvested from the tissue of aborted fetuses, or dead fetuses created and altered in a laboratory for scientific purposes, and 2) That actual operations using stem cells derived from human tissue will be a phenomenon of the distant future – they won’t be available here in the United States for at least another decade. Yet here at the California Stem Cell Treatment Center, our patients have been receiving stem-cell injections since December of 2010. If conventional thinking places stem cells squarely in the future, how is it possible for us to offer leading-edge treatment right now? And is this even legal?

For starters, the cells that our team works with are non-embryonic cells; CSCTC uses strictly adult (not fetal) tissue and autologous cells, meaning the cells are taken from the person that receives them – donor and recipient are one and the same. Embryonic cells are hailed in the media for their pluripotent property, meaning they can differentiate into any type of cell in the body. However, embryonic cells don’t relate well to adult tissue; they want to grow into a fetus, which is abnormally rapid growth in any context other than a pregnancy, resulting in the formation of teratomas which is a type of uncontrolled neoplastic (cancerous) growth. Such tumor formation has been clinically documented and has severely limited the clinical use of embryonic stem cells which is problematic since most of the basic science stem cell work done in the past 15 years has been using these embryonic cells. The adult cells that we use at CSCTC are not pluripotent, but they are plenty potent for regenerative healing. These adult stem cells (ASCs) derived from fat have been documented to be capable of forming nearly every type of tissue in the human body except placental tissue. We have proof that fat derived stem cells can form nerve tissue and other complex organs. (See addendum- History of Adipose Derived SVF).

Learn to love your body fat: It’s loaded with mesenchymal stem cells, a.k.a. multipotent stromal cells, or MSCs, that can differentiate into a variety of cell types. These same cells may also be isolated from several other sources in the body, including bone marrow and the umbilical cord (cord blood cells are adult cells, not embryonic ones). For millennia, the lifeline joining mother and infant was discarded after birth; in recent years, however, growing scientific awareness that the umbilical cord is a rich reserve of stem cells has spurred the development of technology enabling parents to choose the option of having their cord blood preserved and cryobanked (deep frozen at -190°C) for their own and their children’s future medical use. However, the focus on the cryopreservation of cells has been to bank HSC’s also known as hematopoetic stem cells, which are a type of stem cell that is especially intended to form blood products and can be useful in patients that have blood line tumors like leukemia and need therapies that destroy the persons own blood and immune cells which then need to be repopulated with HSC’s. There are a very small number of MSC’s in umbilical cord but this is a poor source compared to fat.

Bone marrow MSCs have been used for a number of years, particularly for a variety of orthopedic conditions; however, they are found in relatively low numbers, and require FDA approved laboratory growth (using GMP also known as good manufacturing practices) to ensure adequate amounts for regenerative purposes. Also, with chronic illness and advanced age the bone marrow is suppressed, and this negatively impacts the quality and quantity of the cells. As cancer patients who have undergone harvesting of their bone marrow appreciate, the removal process is difficult, painful, and invasive. As noted above, the MSCs used at our practice are adipose-derived cells, meaning they are harvested from the patient’s own fatty tissue. It turns out that fat has 2,500 times the number of MSCs as bone marrow; the cells simply lie dormant in the collagen matrix of the fat, but can be made readily available for release and bio-available to our damaged tissue for repair purposes. Scientists abbreviate the term adipose-derived stem cells as ASC, to distinguish them from bone-marrow-derived stem cells, or BSC. While different camps will try to argue that bone marrow cells have advantages over fat-derived cells, studies show that the cells derived from fat are equal – if not superior – in regenerative potency to the stem cells derived from bone marrow.

At CSCTC we employ a mini-liposuction technique to remove the fatty tissue. Liposuction has been the single most popular cosmetic procedure in the United States for several years now. Of course, with basic liposuction the goal is to remove unwanted fat that the patient can’t otherwise lose by normal diet and exercise. Amazingly, while fat frequently finds use in transplantation for facial rejuvenation, breast augmentation, buttock augmentation, and a variety of defect repairs, it is otherwise largely discarded. Today, we know that there are 500,000 to 1 million stem cells in each milliliter of fat – yet during routine cosmetic procedures, surgeons were discarding what amounted to billions of these incredibly important regenerative cells. In most cases, the MSC-rich adipose tissue continues to be discarded. Most liposuction procedures require some type of sedation in addition