Archive for November, 2017

The Future of Medicine Has Arrived!

Carson B. Burgstiner MD was a pioneer in the field of Regenerative Medicine, practicing and promoting preventive health strategies that were well ahead of his time and transforming innumerable lives under the guiding principle that “If you maintain normal physiology, you can prevent disease and pathology”. Having enjoyed the privilege of testing and expanding Dr. Burgstiner’s legacy for the last twenty years, we have seen that his philosophy of restoring integrity to the bioterrain through the Burgstiner Wellness Protocol not only prevents chronic illnesses, but may often times even reverse them.

My father was a strong proponent of glandular therapy, an ancient form of medicine in which a patient may strengthen the health and function of a troubled gland by consuming corresponding glandular tissues of another species. Dr. Burgstiner’s clinical experience and research demonstrated that the efficacy of glandular extracts could be profoundly enhanced by combining them with various vitamins, minerals and other cofactors that serve to activate their expression.

Dr. Burgstiner recognized the unique promise and incredible utility of glandular extracts because “when you ingest glandular tissues, not only are you getting gland – specific nutrients, but you are getting information encoded in the genetic material of those proteins that cannot be conveyed in any other way… and certainly not with a drug.” Since my father’s untimely death in 1996, many advancements have been made in biologics and Regenerative Medicine, but none more exciting than the explosion of research surrounding the vast potential of human stem cells.

Scientists at first believed that once stem cells were transplanted, they went to work by differentiating into whatever tissues were needed and then replicating themselves as needed. However, research has shown that their primary mechanism of tissue repair stems from their role as messenger or signaling cells.

Much like glandular therapy, transplanted stem cells exert their amazing and sometimes miraculous influence by transmitting critical information to damaged or dying cells in the form of growth factors, cytokines, chemokines and signaling proteins. Indeed, last year Dr. Arnold Caplan (the eminent research scientist considered to be the “Father of Mesenchymal Stem Cells”) petitioned the scientific community to change the name of MSC’s to “Medicinal Signaling Cells” because of their unique ability to activate or rejuvenate endogenous stem cells and tissues.

Lets take a closer look at stem cells and see how they are changing the landscape of medicine.

What are Stem Cells?

Stem cells are a class of remarkable cells that can develop into any type of cell, and form the basis of human development and maintenance. A stem cell is essentially a “blank” cell, capable of reproducing or becoming another more differentiated cell type. Once sperm meets egg and a blastocyst is formed, embryonic stem cells are responsible for the normal development of the zygote into an embryo.

Scientists learned how to remove embryonic stem cells from the inner cell mass of human embryos in 1998, but the moral implications of destroying them – along with the implications of human cloning – resulted in a 2001 law prohibiting the creation of embryos for research purposes and limiting federal funding for embryonic stem cell research to a study of 70 or so existing cell lines. There are also unresolved safety concerns with embryonic stem cells because they are capable of transmitting DNA into the cell nucleus of a host – possibly with unintended consequences.

Embryonic stem cells continue to hold great promise in medicine (as do IPSC’s – or Induced Pluripotent Stem Cells – which are cells that have been genetically manipulated into stem cell – like cells), but for the purposes of this discussion, we will be focusing only on non-embryonic stem cells, which do not pose such safety concerns. There are different types of non-embryonic stem cells in our bodies. Hematopoietic stem cells (HSCs) are blood stem cells that give rise to all components of blood. Mesenchymal stem cells (MSCs) or stromal cells have shown much promise in various disease states as they can give rise to a multitude of cell types found throughout our body such as fat, bone, cartilage and muscle.

MSCs release growth factors and proteins to communicate and stimulate neighboring cells, “homing in” on inflammatory signals to stimulate repair and/or replacement of damaged or diseased tissues. They regulate the immune system by increasing the response of regulatory T-cells and decreasing pro-inflammatory mediators such as TNF-α, and IFN-γ. Because of their immune modulating effects, MSCs may be used from an unrelated donor.

Where Do Stem Cells Come From?

Non-embryonic stem cells can be harvested from a variety of sources including: bone marrow, adipose (fat) tissue, placenta and cord tissue, and umbilical cord blood. Adult stem cells have been found in the brain, bone marrow, blood vessels, skeletal muscle, skin, teeth, heart, gut, liver, and other organs and tissues.

For purposes of stem cell therapy, doctors most often use stem cells harvested from your bone marrow or adipose tissue, cells harvested and prepared by a lab from irradiated neonatal tissues or amniotic fluid, or they can use live stem cells properly harvested from umbilical cord components or blood.

Are Stem Cell Treatments FDA Approved?

Stem cell treatments are not specifically FDA approved; they are considered investigational, but are permissible. Most patients do not realize this, but many of the treatments they receive on a weekly or yearly basis are technically not “FDA approved”. One example of this is the prescribing of any medication in an “off-label” fashion.

Stem cells are collected, processed, rigorously tested and distributed under the FDA guidelines for Human Cellular and Tissue based Products (HCT/P) (21 CFR Part 1271), 361 human cell and tissue product, state regulations and guidelines of the American Association of Tissue Banks (AATB).

What is the Evidence For Effectiveness and Safety For Using Stem Cells and Bio-Restorative Treatments?

The evidence is surprisingly robust and growing rapidly (there are currently over 5800 clinical trials published on stem cells in the international database). There are numerous scientifically rigorous studies (clinical and laboratory based) that support both the effectiveness and safety of these treatments. Among other things, clinical trials using MSC’s have been conducted for suppression of GVHD (Graft Versus Host Disease), severe autoimmune diseases, repair of skeletal tissue, amyotrophic lateral sclerosis, chronic spinal cord injury, non-healing chronic wounds, vascular disease, coronary artery disease and myocardial infarction. Currently, the largest number of clinical trials is in patients with heart disease.

Due to FDA and FTC regulations, stem cell companies cannot promote (advertise) the use of stem cells for systemic (IV) applications, and most injections are still being done as an alternative to knee or hip replacement, to ease joint pain or peripheral neuropathy, or to reverse tendon or ligament damage. However, many practitioners are very successfully treating chronic illnesses and autoimmune disorders using mesenchymal stem cells (and the published studies on stem cells and Lyme Disease, MS, Lupus, Parkinsons, and many others are indeed impressive).

Despite the incredible potential that stem cells bring to Regenerative Medicine and the clinical success stories associated with them, there is cause for sober caution and sound judgement in regard to their use. As we shall see, all stem cell preparations are not equally effective, and unfortunately, some players in the market are more interested in short term profits than long term positive outcomes.

What Kind of Stem Cells Should I Consider and Why?

Even though we all have our own adult stem cells, there are substantial drawbacks to harvesting and transplanting your own. First, to remove and then reintroduce adult stem cells from your body requires a surgical procedure (bone marrow aspiration or liposuction), which as in every procedure, carries some risk along with considerable pain and discomfort. Second, our stem cells age as we do and their numbers and potency decline dramatically with age. Finally, there is scientific evidence demonstrating that adult stem cells from a diseased patient are not as effective as those from a healthy one.

Progressive Declining Gene Expression of Stem Cells

Once we are born, our stem cells go through three distinct phases of gene expression during the human life cycle. Early in life, our stem cells are programmed for rapid growth and differentiation, and they are most active and numerous during the early stages of human growth and development. From puberty until middle age, our stem cells are expressing genes that lead to slower growth and maturation. In later years, our stem cells – which are progressively declining in numbers, potency and viability – are all about maintaining what is left of our health. So why would anyone want to use adult stem cells that are less viable and programmed for maintenance when they could use new cells that are bursting with life and programmed for rapid growth and differentiation?

Obviously there are strategic advantages to using neonatal stem cells that are young and vibrant, but there are also challenges. Some practitioners use preparations harvested from amniotic fluid which are somewhat effective for intra-articular applications (joints), but with significant limitations due to federally mandated processing requirements for amniotic fluid which require that it be flash frozen before processing – which destroys the stem cells therein. Amniotic stem cell preparations contain many of the growth factors and signaling proteins produced by MSC’s (which is why they are somewhat clinically effective), but their diminished effects are not sustained since there are no live stem cells present to continue producing them.

Zeroing in on the potential superiority of neonatal tissues, some stem cell companies have turned their attention to various umbilical cord tissue components (such as Wharton’s Jelly) to produce their regenerative preparations, but the results are once again disappointing. Because of the complexity, harshness and time consuming nature of the process required to harvest and isolate the stem cells, these preparations produce relatively few live stem cells, and with a low percentage of viability.

A Giant Leap Forward

The umbilical cord serves as a conduit of a vast array of nutrients for a developing fetus. Oxygenated nutrient rich blood is carried from the placenta to the fetus until the baby is born. Cord blood is rich in primitive stem cells, growth factors and immune cells that are naïve as they have to be compatible for baby and mother. The healing potential of umbilical cord blood (UCB) derived stem cells is exponentially greater than using adult stem cells, many of which have already become senescent (unable to grow, divide and secrete vital proteins) to varying degrees.

Unlike amniotic fluid and placental tissue, cord blood is not required by law to be flash frozen or irradiated before it can be processed under AATB regulations, so the integrity and viability of its life giving milieu of cells can be preserved through the combination of a gradual cryopreservation technique and using nontoxic agents that alter cell membrane permeability to prevent crystallization and cellular destruction during freezing. UCB derived MSC’s demonstrate superior efficacy to adult stem cells, with exponentially greater proliferation potential and a much lower senescence rate – which translates into enhanced potency, greater anti-inflammatory effects, better immune modulatory effects, and a more pronounced and sustained clinical result.

Stem cells from Umbilical Cord Blood are harvested from healthy full term births (typically planned C Sections) from parents that have been screened for social hazards and infectious diseases. At the moment, it appears that the vast array of undifferentiated and immune regulating neonatal cells and signaling proteins that find their unique origin in umbilical cord blood present the most potent, consistent and profound asset available in the world of Regenerative Medicine.

As Coach Lee Corsi of ESPN says, “Not So Fast!”

Proponents of autologous adult stem cells (harvested from your own body) are quick to point out valid concerns about blood matching and rejection issues associated with blood or tissue based products that are not your own. The red blood cells, fragments and blood antigens (as well as Type II Histocompatibility proteins such as HLA-DR that are associated with host vs graft disease) found in cord blood might indeed pose a problem if not properly removed from a stem cell preparation prior to injection into a host. Therefore, a company that could master the challenge of removing these proteins and freeing it from all rejection and blood matching concerns would truly possess the Gold Standard in Regenerative Medicine – with consistent and profound healing properties unlike anything else that can be found here in the United States.

The Blessing

Actually, there is such a company, and we have recently partnered with them to share their amazing technology with the world and push forward the boundaries of medicine. Like my father’s discovery of how combining vital nutrient factors with glandular therapy potentiated its benefits, we are now using targeted nutrition to augment the regenerative powers of stem cells. What a blessing it is to carry on with my father’s legacy on the cutting edge of medicine.


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