God’s Message to Men

God is Able to Break Every Chain

The Problem

“The Heart of Man is deceitful above all things” (Jeremiah 17:9)

“We have all sinned and fallen short of the glory of God” (Romans 3:23)

There is none righteous, no not one” (Romans 3:10)

“For I know that nothing good dwells in me, that is, in my flesh. For I have the desire to do what is right, but not the ability to carry it out. For I do not do the good I want, but the evil I do not want is what I keep on doing.” (Romans 7:18-19)

The Wages of Sin is Death (Greek “thanatos” means “separation”)

“My people perish for lack of knowledge” (Hosea 4:6)

Cycle of Sin :                         Cycle of Sin in Judges                                

The name “Satan” means “Adversary” and “Accuser” He is the father of lies and the great deceiver. If you allow him to, he will use you and others around you like a puppet. Have you entered into agreements with him based upon lies he told you about yourself?

Temptation === Condemnation Woundedness === Brokenness === Bondage

The Good News

“But God demonstrates his own love for us in this: While we were still sinners, Christ died for us.” (Romans 5:8)

“The thief comes only to steal and kill and destroy; I have come that they may have life, and have it to the full.” (John 10:10)

“There is therefore now no condemnation for those who are in Christ Jesus. For the law of the Spirit of life has set you free in Christ Jesus from the law of sin and death. For God has done what the law, weakened by the flesh, could not do. By sending his own Son in the likeness of sinful flesh and for sin, he condemned sin in the flesh, in order that the righteous requirement of the law might be fulfilled in us, who walk not according to the flesh but according to the Spirit.” (Romans 8:1-4)

“So I find this law at work: Although I want to do good, evil is right there with me. For in my inner being I delight in God’s law; but I see another law at work in me, waging war against the law of my mind and making me a prisoner of the law of sin at work within me. What a wretched man I am! Who will rescue me from this body that is subject to death? Thanks be to God, who delivers me through Jesus Christ our Lord!” (Romans 7:21-25)

 

God’s Message to Men

Know Who Your Enemy Is

“For we do not wrestle against flesh and blood, but against the rulers, against the authorities, against the cosmic powers over this present darkness, against the spiritual forces of evil in the heavenly places. 13 Therefore take up the whole armor of God, that you may be able to withstand in the evil day, and having done all, to stand firm.” (Ephesians 6:12-13)

Love the Lord your God

“With all your heart and with all your soul and with all your strength and with all your mind”; and, “Love your neighbor as yourself.” (Deuteronomy 6:5, Luke 10:27)

Guard Your Heart

“Therefore, I urge you, brothers and sisters, in view of God’s mercy, to offer your bodies as a living sacrifice, holy and pleasing to God—this is your true and proper worship. Do not conform to the patterns of this world, but be transformed by the renewing of your mind. Then you will be able to test and approve what God’s will is—his good, pleasing and perfect will.” (Romans 12:1-2)

Be Bold and Courageous

“Do not fear or be in dread of them, for it is the LORD your God who goes with you. He will not leave you or forsake you.” (Joshua 1:9, Deuteronomy 31:6)

Be Vigilant 

“Be sober-minded; be watchful. Your adversary the devil prowls around like a roaring lion, seeking someone to devour.” (1 Peter 5:8)

Persevere

“Consider it pure joy, my brothers and sisters, whenever you face trials of many kinds, because you know that the testing of your faith produces perseverance. Let perseverance finish its work so that you may be mature and complete, not lacking anything.” (James 1:2-4)

Trust Me

“And we know that God works all things together for the good of those who love Him, who are called according to His purpose.” (Romans 8:28)

“But they that wait upon the LORD shall renew their strength; they shall mount up with wings as eagles; they shall run, and not be weary; and they shall walk, and not faint.” (Isaiah 40:31)

Make Disciples

“Therefore go and make disciples of all nations, baptizing them in the name of the Father, and of the Son, and of the Holy Spirit, and teaching them to obey everything I have commanded you. And surely I am with you always, to the very end of the age.” (Matthew 28:18-20)

“If God is for us, who can be against us?” (Romans 8:31)

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FDA SHAPES FUTURE OF REGENERATIVE MEDICINE WITH NEW GUIDELINES ON STEM CELLS (Opinion)

FDAThe FDA’s recently published guidelines on Stem Cell preparations entitled Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use brought much needed clarity as to where the agency intends to invest its regulatory efforts in the most promising area of Regenerative Medicine. In recent years, research on stem cells has skyrocketed, revealing and confirming their incredible healing potential and unleashing a flood of marketers looking to cash in on the lucrative opportunities they create.

Such opportunities always have and always will attract undesirable elements, such as rogue companies or practitioners who are eager to cash in on desperate but ignorant patients with low cost, inferior products or who adulterate their preparations with smallpox vaccine (to supposedly treat cancer) or fetal bovine serum (to accelerate the growth of cells – which is both potentially dangerous and illegal). To their credit, the agency (as well as the FTC) has dealt aggressively with obvious offenders and taken a stand against disingenuous practices such as marketing “amniotic stem cell” preparations as stem cells when in fact they contain no live stem cells.

The recently published FDA guidelines are a welcome blessing to consumers and a “shot across the bow” to those who have their own agenda in the “Wild West” environment that has ruled much of the industry to date. Best of all, the new guidelines put forth a clear picture from which the legitimate leaders in Regenerative Medicine can differentiate themselves by demonstrating best practices – and by which consumers can make informed treatment decisions.

REGULATION OF STEM CELLS

As long as they meet certain requirements, human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are intended for transplantation into a human recipient are regulated by the FDA under Title 21 of the Code of Federal Regulations (CFR) Part 1271 and section 361 of the Public Health Service (PHS) Act. If an HCT/P does not meet the four criteria set out in 21 CFR1271, the HCT/P will be regulated as a new drug, device, and/or biological product under the FD&C Act and section 351 of the PHS Act (and therefore would require premarket approval and an Investigational New Drug (IND) Application which takes 5-10 years and $10-$20 million to complete).

In order to avoid being regulated as a new drug, an HCT/P must:

1. Be minimally manipulated.
2. Be intended for homologous use only.
3. Not combine the cells or tissues with another article, except for water, crystalloids or a sterilizing, preserving or storage agent, and
4. Not have a systemic effect and not be dependent on the metabolic activity of living cells for its primary function. Or if it does have a systemic effect or is dependent on the metabolic activity of living cells for its primary function, its use must be autologous, reproductive, or allogenic in a first-degree or second-degree blood relative.

In developing the so called “tissue rules” in section 361 of the PHS, the FDA focused on “public health and regulatory concerns including how transmission of communicable diseases can be prevented; what processing controls are necessary to prevent contamination that could result in an unsafe or ineffective product, and to preserve integrity and function so that the products will work as they are intended; and how clinical safety and effectiveness can be assured”.

These same concerns were the driving force behind the agency’s updated Guidelines, which focused primarily on the two criteria which arguably contribute most to mitigating risks and maximizing the safety and efficacy of HCT/Ps: minimal manipulation and homologous use.

Minimal Manipulation

In defining minimal manipulation, the agency made a very important and insightful distinction between the processing of stem cells harvested from structural tissue (such as placenta, umbilical cord, or fat tissue) or nonstructural tissue (such as cells found in umbilical cord blood, reproductive cells, glands and organ tissues). HCT/Ps that physically support or serve as a barrier or conduit, or connect, cover, or cushion in the donor are generally considered structural tissues, and those that serve metabolic or other biochemical roles in the body such as hematopoietic, immune or endocrine functions are generally considered cells/nonstructural tissues.

For structural tissue, processing may not alter the original relevant characteristics (such as strength, flexibility, cushioning or covering) of the tissue relating to the tissue’s utility for reconstruction, repair or replacement. So if you take adipose (fat) tissue and break it down using enzymes in order to gain access to the stem cells it contains, you compromise its structural integrity irreversibly and it could not go back to performing its prior function in the body of the donor. The FDA guideline makes the determination of whether an HCT/P is minimally manipulated based upon the effect of manufacturing on the original relevant characteristics of the HCT/P as it existed in the donor prior to recovery and any processing that takes place (and not on the intended use of the HCT/P in the recipient).

Adipose stem cell procedures clearly do not satisfy the minimal manipulation requirement because the processing required of adipose tissue alters its utility regarding providing cushioning and support. Similarly, if you chop and grind up umbilical cord or placental tissues and treat them with enzymes to gain access to the stem cells therein, the structural integrity of the tissue is forever compromised and the minimal manipulation standard has not been met.

For cells or nonstructural tissues, the guideline states that processing may not alter the relevant biological characteristics (i.e. – the differentiation or proliferation potential or metabolic activity) of the cells or tissues. Because of their minimal processing, stem cells harvested from umbilical cord blood clearly do pass the minimal manipulation standard.

Incidentally, the processes used to harvest and prepare stem cells from bone marrow aspirate would also not likely be considered minimal manipulation, but for whatever reasons, bone marrow enjoys special status and is excluded from being considered an HCT/P.

Homologous Use

Section 1271.10(a)(2) states that in order for an HCT/P to qualify, it must be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” This means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P must perform one or more of the same basic functions in the recipient as in the donor.

Basic functions of a structural tissue would generally be to perform a structural function such as to physically support or serve as a barrier or conduit, or connect, cover or cushion.

The basic functions of umbilical cord include serving as a conduit for blood flow from a mother to her fetus. If umbilical cord is mechanically and enzymatically processed and used to treat musculoskeletal conditions by regenerating or promoting the generation of articular cartilage or tendon, this would not be considered homologous use because regenerating or promoting the regeneration of cartilage or tendon is not a basic function of umbilical cord tissue.

Basic functions of a cellular or nonstructural tissue would generally be metabolic or biochemical functions, such as hematopoietic, immune or endocrine functions. Umbilical cord blood contains a myriad of specialized cells that are responsible for a vast array of metabolic functions pertaining to the development and maintenance of a fetus, any number of which might be harnessed and deployed for homologous use in a recipient seeking regenerative support of targeted tissues.

For example, the most common use of umbilical cord blood stem cell preparations is promoting healing and regeneration of damaged tissues in knee or other joints. This is accomplished by inhibiting inflammatory immune responses in the damaged or underlying tissues, providing growth factors and other trophic nutrients, and revitalizing the body’s own stem cells – thereby creating an optimal environment for healing and regeneration – and clearly a homologous use for the umbilical blood sourced cells.

COMPLIANCE AND ENFORCEMENT

The FDA is allowing 36 months to give manufacturers time to determine if they need to submit an IND Application in light of the new guidelines, and intends to exercise enforcement discretion unless an HCT/P is deemed to present a significant safety concern. Meanwhile, the agency will focus enforcement actions on products with higher risk, taking into account factors such as where the cells or tissues are sourced and route and site of administration. Actions related to procedures associated with higher risk (such as IV injection or infusion, aerosol inhalation, intraocular injection or injection or infusion into the central nervous system) will be prioritized over those associated with a lower risk (such as intradermal, subcutaneous, or intra-articular (joint) injections).

The FDA is more likely to target practitioners that are actively marketing systemic applications for the prevention or treatment of serious and/or life threatening diseases and conditions, allegedly because there is less basis on which to predict the product’s behavior in the recipient, but also because the use of “unapproved” stem cell products may cause patients to delay or discontinue medical treatments that have paid the price to be deemed safe and effective by the agency (i.e. – drugs and surgery).

CONCLUSIONS

So how did the recently published FDA guidelines change the landscape of Regenerative Medicine for the established players in terms of regulatory concerns and long term positioning in the marketplace?

Bone Marrow – Stem cell therapy started with bone marrow transplants many years ago, and its status from a regulatory standpoint was virtually unaffected by the new guidelines. It will likely remain a mainstay treatment (especially for musculoskeletal specialists such as orthopedic practitioners) because of its long established practice – even though the results it offers are inconsistent at best because they are so dependent upon the age and health of the patient – who also must endure the added risk, pain and discomfort of the harvesting procedure.

Adipose (Fat) – Practitioners who have made substantial investments into equipment and training to harvest and process stem cells and perform transplants from their patients’ own adipose tissue are most adversely affected by the new guidelines which clearly demonstrate that adipose stem cell preparations do not qualify under either the minimal manipulation or the homologous use definitions in the guidelines.

Such procedures will eventually be abandoned in favor of other stem cell sources, and the sooner the better. Adipose derived stem cells have been shown to have inferior growth kinetics, potency and viability compared to other sources – possibly due to the fact that our fat is where toxins are stored by the body, and like all autologous stem cells (derived from the patient who is also the recipient), their efficacy is greatly dependent on the age and health of the patient.

Amniotic – Amniotic “Stem Cell” companies have already been under fire by the FTC for marketing stem cells when their products contain no live stem cells by virtue of the way they must be processed by law. To add insult to injury, their products also run afoul of the new guidelines, not qualifying under either the minimal manipulation or homologous use guidelines for HCT/Ps. One exception would be the use of amniotic membrane as a skin covering on a burn patient which would be considered homologous use.

Neonatal Structural Tissues (Umbilical Cord, Wharton’s Jelly, Placenta, etc.) – Because these are structural tissues, the processing requirements in order to harvest the stem cells they contain do not appear to qualify under the minimal processing or homologous use guidelines either.

As the guidelines point out, structural HCT/Ps generally raise different safety and efficacy concerns than do cells or nonstructural tissues. The FDA appears to recognize and appreciate that the processes required to harvest stem cells from adipose or structural neonatal tissues are not only detrimental to the potential number and integrity of the stem cells harvested, but they may introduce new and undesirable risks (such as contamination, infection or inadequate undifferentiation of harvested cells).

Umbilical Cord Blood – As a distinctly cellular (nonstructural) tissue, the processing of stem cells from umbilical cord blood clearly qualifies under the minimal manipulation guideline, and their metabolic functions in the donor and recipient are certainly applicable under the homologous use guideline as well. So companies that manufacture stem cell preparations from umbilical cord blood emerged as by far the greatest beneficiaries of the new guidelines (as long as they don’t advertise or promote the systemic use of their stem cells).

However, unless they are properly processed, umbilical cord blood derived stem cell preparations still present the practical hazard of blood matching and blood antigen rejection issues in the host. Please note, at least one company has perfected the task of removing all red blood cells, fragments and antigens from cord blood at this time. It is only a matter of time before others will follow suit, and this will be a blessing to consumers and practitioners alike.

Cord blood derived stem cells deliver all the advantages of neonatal sourcing (higher cell counts, better cell viability, and greater potency) which leads to more consistency, enhanced efficacy and better patient outcomes – a win/win for doctors and patients alike.

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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Eulogy For My Dear Friend, Sonny Hambrick

George F. Hambrick Jr.
(May 4, 1961 – September 7, 2015)

I can think of a thousand places I would rather be today than speaking at a funeral service, especially one for my cherished friend, Sonny Hambrick. At the same time, there is no place that I would rather be than right here, right now. You see, we cannot truly appreciate the joy and ecstasy of life until we experience the agony and separation of death.

Yes, there is a time for everything under heaven, even grief. Despite our culture of immediate gratification and the avoidance of anything difficult or painful, we all find ourselves compelled to be here to honor the memory of Sonny Hambrick because of one reason: we loved him or someone in his immediate family.

I am honored to be here today to speak on behalf of Sonny and his family. When Rhonda asked me if I would be willing to share some stories about Sonny with you, I began to think about which words I would use to describe him:

Sonny was Bold and Fearless – When we were young and full of vim and vigor, if you found yourself in an unpleasant situation where you needed someone to have your back, there was no one better than Sonny. He was not afraid of anyone or anything, and he was always ready to “throw down” if he had the opportunity. Sonny would have made a great NFL football player or a terrific soldier… except for the fact that Sonny didn’t particularly care for people telling him what to do.

Sonny was Loving and Kind – If you talk to others about Sonny or read what has been written about him by friends, family and coworkers since his untimely death, a common theme begins to emerge of his humility and kindness. I knew this side of Sonny even when he was young and full of bravado, but life has a way of softening even the toughest among us if we will allow it to. Sonny loved people and he loved animals, especially dogs.

Sonny was Spontaneous and Fun Loving – Sonny enjoyed life to its fullest, and I think that is what attracted us to each other when I first came to Savannah Christian for my junior year of high school. It didn’t take us long to become running mates. He was always ready for an adventure, whether it be a road trip, or a midnight sailing excursion.

Sonny loved the University of Georgia and his Bulldogs. We attended UGA together as room mates in the Fall of 1980 during the glory years of UGA football, when Hershel Walker ran over anyone in his path, when Erk Russell stalked the sidelines with blood all over his face from head butting his defenders, when James Brown thrilled Sanford Stadium with his song, “Dooley’s Junkyard Dawgs”. We soaked up every moment of that incredible year when UGA won the National Championship. We were together when Larry Munson screamed “Run Lindsay! Run Lindsay!” and “Look at the sugar falling from the sky!”.

We had no idea how blessed we were and how special those times were. It was fun to win and fun to learn. Fun to work and fun to play. The legal drinking age was 18 when Sonny and I arrived in Athens, and lets just say we took maximum advantage of that fact. I’m not going to get too far into what we did in those days, other than to say two things:

1. Thank you Lord for looking after us in our stupidity.
2. I’m so glad we didn’t have cell phones and YouTube!

I remember one frigid night in February, Sonny and I got into a silly disagreement and got separated at a fraternity party. I ended up catching a ride back to our dorm, which for those of you who know Athens, was on the first floor of Milledge Hall. I didn’t have my room key so I knocked on the door. No answer. “So this is how its gonna be.” “I said I’m sorry, you blankety blank! Let me in!” Still no answer. After banging on the door for a few more minutes, it was obvious that he was determined to ignore me, so I did what any responsible, level headed young man would do in that situation. I went outside and kicked one of the window panes in – only to find that Sonny was not in there. When he showed up a short time later, I told him the story and we nearly died that night of laughter and the sub freezing temperature in our room.

Sonny and I both married our high school sweethearts. Unfortunately, my dear wife Jahn could not be here with us today because of unavoidable conflicts, but trust me, she is here in spirit. She and Rhonda used to burn up the highways together between here and Athens every weekend. When I asked Jahn what her favorite memory of Sonny was, she said “Walking into your dorm room to the sound of Sonny singing Kenny Rogers love songs to Rhonda”.

I hate to admit it, but Sonny and I were both kind of free flowing in our love of the ladies when we were young. You might have even called us “Lady’s men”. However, when Sonny fell for Rhonda, he fell hard. Rhonda put a spell on Sonny that no one saw coming. He didn’t care that people said he was robbing the cradle. He was madly in love, and the fact that she was barely a teenager was irrelevant. Rhonda has stayed by his side through thick and thin ever since, and I can’t imagine how lost she must feel at this moment. Rhonda, I pray that God will comfort you in your temporary separation from Sonny, and He will fill your mind with all the many sweet memories you have together.

Sonny cherished his family – all of them. From his sweet mom Miss Ann who I affectionately called Mom too, to his lovable Dad George who tried his best to keep us out of trouble, to sweet Pam who he adored, Deborah and all the extended family. But most of all, he loved Rhonda and his precious children Trey and Macy. He loved to call and tell me all about how they were doing. He called me and asked for prayer when Rhonda lost her job, and called to let me know when she got a better one. He was incredibly proud of you Trey and Macy, and he will remain your greatest fan as you embrace an uncertain future without him. I pledge to each of you today – as do many people in this room – to be there for you should you need me.

I will miss getting those phone calls out of the blue when I answer my phone and all he says is “Hey”, and instantly I am transported back in time to our magical days of college and of starting our families together. With Sonny and me, time was irrelevant. We always picked up where we left off without missing a beat. Frankly, he did a better job than I did of staying in touch, but what a sweet friendship we had. He knew me as well as anyone on this earth – and loved me anyway.

Today we celebrate Sonny’s life and his legacy of love. His light burned brightly, and his departure from this earth leaves us feeling the stinging pain of grief. Grief as they say, is the price of love. However, even as we grieve, there is a celebration of homecoming for Sonny in heaven.

Its funny; You would never have voted either of us “Most likely to become Sunday School Teachers”, but God’s amazing grace and loving protection covered us in our youthful exuberance, and He used every experience, every choice – good and bad – and every precious relationship to grow and mold us.

Don’t get me wrong… neither of us are saints, and neither of us are evangelists, but if Sonny were able to stand before you today after meeting His savior face to face, he would remind you all of your mortality, and he would implore you to settle in your mind and in your heart the most critically important question you will ever be confronted with: That is “Who is Jesus Christ, and how does the answer to that question affect me?”
For all have sinned and fallen short of God’s standard of righteousness. The wages of our sin is death, or separation from God. But God demonstrates his love for us in this: while we were yet sinners, Christ died for us.

Sonny has left the prison of his flesh and entered into eternity in the presence of and in direct fellowship with God. He no longer suffers from compromised liver or kidney function, and the weaknesses that kept him keenly aware of his dependence on God no longer hinder him. Sonny has been rewarded for his faith, and now he is at perfect peace.

I take great comfort in that, and I sincerely hope that you do too.

God Bless you all.

Is Your Health Being Undermined by This Common but Deadly Sleep Disorder?

Several years ago, at the request of my dear wife, I got tested for sleep apnea, and it probably saved my life. She had patiently endured my snoring, but as a nurse, she was disturbed by the increasing frequency of episodes when I appeared to stop breathing – as well as my increasing weight gain and levels of fatigue and irritability. So off to the sleep center I went…

In case you aren’t familiar with this condition, apnea means “no breath,” and obstructive sleep apnea is the periodic stoppage of breathing while asleep. It is caused by a partial or complete blockage of the airway by the tissues in the back of the throat. Oxygen levels in the blood drop and carbon dioxide rises, waking you up just enough to start breathing, but not enough to be aware of the feeling of terror that comes with not being able to breathe. For those who have severe sleep apnea, the result is you wake up feeling exhausted, perhaps covered in sweat and often with a dry mouth and sore throat.

People who suffer with even mild sleep apnea get sleepy during the day, and it’s no wonder. This continuous arousal prevents them from getting adequate rapid eye movement (REM) sleep—the deepest, most rejuvenating and essential level of sleep.

During my evaluation for sleep apnea, I had 110 attacks of apnea (spells when I stopped breathing for 10 seconds or longer) in one hour. Not a good thing! My oxygen level was low, and I got virtually no restorative REM sleep.

Sleep Apnea Is Catastrophic to Your Overall Health

A ton of research reveals links between sleep deprivation and a broad range of health concerns. In addition to making you exhausted and cranky, poor sleep can trash your memory and mood, make you gain weight, raise your blood pressure and blood sugar, stress your immune system, increase your risk of diabetes, stroke, heart attack, and dementia.

Sleep apnea can set off a cascading nightmare of deteriorating health that spirals out of control before you know it. The combination of deprivation of REM sleep plus other ill effects of sleep apnea (such as significant drops in oxygen levels in the blood, fluctuations in hormone levels, and elevations in blood pressure, heart rate, and cardiac output) wreaks havoc on the body.

Lower blood oxygen levels in men who have severe sleep apnea slows testosterone production in the testes, resulting in weight gain, loss of energy and stamina, impaired focus and motivation and even lead to chronic anxiety or depression.

According to a study published in the New England Journal of Medicine, people with sleep apnea have three times the risk of developing high blood pressure as those without this sleep problem. Sleep apnea is also an independent risk factor for coronary artery disease and stroke. These conditions are associated with increased levels of oxidative stress, C-reactive protein, and clotting factors, and all of these are elevated in people with sleep apnea. Cardiac arrhythmias and congestive heart failure are also much more common among sleep apnea sufferers.

It is said that 1 in 5 Americans suffer from sleep apnea to some degree. There is also a significant relationship between sleep apnea, elevated blood sugar and insulin, and insulin resistance. Severe sleep apnea is associated with a five-fold increased risk of diabetes. Obesity, a related condition, is also associated with sleep apnea, although the exact relationship is harder to understand since obesity is often a primary cause of sleep apnea as well. Erectile problems, immune dysfunction, memory loss and concentration difficulties… the list of problems associated with sleep apnea goes on and on.

The Most Effective Sleep Apnea Treatment

When I was diagnosed with sleep apnea, I immediately began using a continuous positive airway pressure (CPAP) machine, which is a device worn at night that delivers a steady stream of air to keep the airways open. I couldn’t believe how much it improved my quality of life. Some people complain that their CPAPs or APAPs (an automatic version of CPAP) are uncomfortable, and they do take some getting used to.

Since I started using this sleep apnea treatment, I’ve slept without my CPAP machine only rarely, and not by choice. I may occasionally forget to pack something, but I (almost) never forget my CPAP because I am so convinced of the tremendous benefits offered by a good night’s sleep.

Automatic and continuous positive airway pressure (APAP and CPAP) machines are hands down the best-studied and most effective treatment for sleep apnea. Attempting to lose weight without a CPAP is very difficult because each episode of apnea releases stress hormones that promote weight gain. Although I’ve been using this therapy myself for years and have never had any problems, I do understand that not everyone tolerates it so well. For me, I found that a small mask covering only my nose worked much better than a full face mask.

According to the American Sleep Apnea Association, compliance rates hover around 60 percent, and mask discomfort and nasal issues are common roadblocks. However, because sleep apnea has such serious adverse effects on your health, the benefits of treatment far outweigh the discomforts of the therapy. That’s why, if you are diagnosed with sleep apnea and prescribed APAP or CPAP, you need to work with your doctor to try different masks, a humidifier, and other potential solutions before giving up on it.

Secondary Treatments for Sleep Apnea

I wish there was a proven alternative to CPAP/APAP for those who simply cannot tolerate this sleep apnea treatment. Oral appliances, dental interventions, surgical procedures, and positional therapies are certainly worth a try, but can’t guarantee results. That being said, everyone with sleep apnea can and should use natural therapies to address underlying health problems such as thyroid insufficiency, insulin resistance or metabolic syndrome.

Almost everyone with sleep apnea will benefit from losing weight. In fact, adequate weight loss will completely eliminate the condition in many, and losing 20 to 30 pounds will result in significant improvements. Avoiding alcohol may also be helpful. This is especially true for individuals with mild cases, who may snore and have episodes of apnea only after having a drink. Taking sedatives or analgesics at bedtime can have similar effects, so getting off such drugs may help.

Research published in 2009 suggested that specific throat exercises can help by preventing airway collapse during sleep, resulting in better sleep, less snoring, a significant reduction in neck circumference, and an overall decrease in sleep apnea.

Here are a few of the exercises you can do on your own:

1) Repeat the vowels (A, E, I, O, U) over and over again exaggerating enunciation.
2) Do multiple long, drawn-out yawning movements, opening your mouth wide and tightening the muscles in the back of your throat.
3) Push your tongue up against the back of your front teeth, slowly run it back over the roof of your mouth as far as you can, then slide the tongue back to its original position against the front teeth. Per the study, about 30 minutes daily of these and similar exercises, which can be done throughout the day, are required for maximum benefits.

Bottom Line: Sleep Apnea is Deadly if Left Untreated!

If you snore, are overweight, and/or have metabolic syndrome, you need to get tested for sleep apnea. If you are or have been diagnosed with this condition, try the CPAP/APAP treatments, start an exercise and weight loss regimen, and take supplements that naturally address some of the underlying issues associated with it. Dramatic changes in sleep apnea symptoms are usually seen in patients losing a mere 10-15% of their body weight as fat.

Logos Nutritionals offers several supplements that can be tremendously helpful. First, for those who need to safely lose weight, MagnifiThin is a wonderful aid to boost metabolism and curb your appetite. For those battling with insulin resistance or Metabolic Syndrome, FitCose 1C is a remarkable breakthrough blood sugar support formula. Last but certainly not least, Sleep Advance has proven to be a superior solution for calming the mind and promoting deep, restful sleep.

Finally, to learn everything you ever wanted to know about sleep, read this very informative article.

James D. McCusker – A Great American

Jim McCusker was my friend from the first moment we met back in 1988 as young men trying to forge a career in (at that time) life insurance sales at Mass Mutual. We spent a lot of time together; at the office studying or preparing proposals, on the road making sales calls, or after work unwinding from the day. Through it all, if you were with Jim, there was never a dull moment. Truth be told, we played as hard or harder than we worked, but I will always cherish the laughs and meals we shared, the late nights drinking scotch and playing putt putt in the office, and the many long conversations (OK yes I mostly listened) in which we pondered all manner of problems and opportunities under creation.

Several things immediately struck me when I befriended Jim:

Jim was at all times and in all circumstances, absolutely unflappable. Never at a loss for words, Jim could talk to anyone about anything, and he often would. He never met a stranger. He was inquisitive by nature and genuinely interested in others.

Jim was smart. Really smart. He was without a doubt the greatest thinker I have ever known. Jim never shared with me what his IQ was, but his vast vocabulary was ever expanding, and he literally knew a little something about everything. And if he didn’t know about something, he was such a skilled pontificator that you would never realize it!

Jim and I shared a healthy general disdain for the powers that be and a certain detachment from the standards that supposedly govern our little region of the universe. We soon picked up on that commonality, and I think it was Jim who coined the term “Burgstiner Time” to describe my more European approach to time management.

Finally, and most importantly, Jim had an immense capacity to love. He was a gentle and kind soul, bold yet humble, and always a servant – especially to young people. Jim was a devoted husband, brother and son, but by far his greatest joy was being a Dad.

As his close friend, I was a grateful recipient of the love that overflowed from Jim’s heart, and it was he more so than I who made the consistent effort to stay in touch once our career paths diverged, even when we moved away to Atlanta. Whenever we got together, whether in person or by phone, it was like no time had passed. We delighted in each other’s company and encouraged one another in our struggles.

Like all of us, Jim was not perfect, but he left behind a legacy of love and a willingness to dream that impacted all who were fortunate enough to be loved by him. Jim’s soaring mind and sweet soul were released from the limited confines of his mortal body on March 26, 2014. We all miss him now, but I look forward with great anticipation to being reunited with him in paradise one day, where the answers to the many questions we pondered together will finally be understood.

THREE RESOLUTIONS WORTH KEEPING

 

Its two thirdbigstock-I-m-The-Best-324629s of the way through January now. Have you, like most Americans, already come up short on keeping your new year’s resolutions if you even bothered with them at all this year? We start out with the best of intentions, but so easily end up getting distracted by the hectic pace and inevitable chaos of life.

 

Despite the advantages of living in the “Information Age” with easy access to all manner of conveniences that are designed to maximize our productivity and quality of life, we are living in challenging times. Our bodies and minds are being bombarded with unprecedented levels of stress. From the relentless demands of immediate interpersonal access (smart phones) to the cumulative burdens of environmental and emotional toxicity associated with living in these days, we would be wise to heed the words of the Apostle Paul who exhorts us to “Be no longer conformed to the patterns of this world, but be transformed by the renewing of your minds”. (Romans 12:2)

Even though we recognize that our body is a temple, it is far too easy to take it for granted and mortgage our future with poor choices today. With that in mind, lets look at a few concrete changes or resolutions that are well worth incorporating into our day to day living for 2015 and beyond:

1. HYDRATE – Dehydration is rampant in our culture, and the insidious toll it takes on your health is even more so considering how easily avoidable it is. The leading cause of kidney stones and constipation, dehydration bogs down your metabolism, making even your cells tired. Make cool filtered water (and a little fresh lemon to help alkalize the body) your drink of choice today, and toss the sodas (especially diet). Drink at least a half ounce of water per pound of body weight per day, and up to twice that amount if you exercise (which you should) or drink alcohol or caffeine (which perhaps you shouldn’t – certainly not in excess).

2. GET MOVING – Regular moderate exercise will do wonders for your metabolism, your energy level, your dress or pant size, and your outlook on life. Not to mention all those infamous markers of health such as blood pressure, cholesterol and triglyceride levels that your doctor uses to assess your body’s obvious lack of pharmaceuticals. Forty five minutes of brisk walking three times a week is enough to make dramatic improvements, but adding some anaerobic exercise and light weight bearing repetitions will greatly enhance and diversify your results (i.e.- bone mass gains,etc.).

3. EAT TO LIVE – We have never had so many choices of foods (and cheaply manufactured items masquerading as food) to eat as Americans do today. Only in the last generation has the demand for consumer convenience and extended shelf life made such a happy marriage, creating massive conglomerates that enjoy obscene profits at the expense of our ignorance and our health.

The “patterns of this world” are ever changing in response to the insatiable lusts of mankind, but make no mistake; the things of this world are fiercely set against the wisdom of God and His children. Paul could scarcely have imagined that 2,000 years after he wrote those inspired words, we would be sitting on the couch mindlessly watching television and snacking on fast foods and soda or a highly processed mixture of genetically modified grains, sugar and toxic fats with a few synthetic vitamins added back in to create an illusion of wholesomeness. God knew that the message He gave to the first century church to avoid the corruption of this world would be pure wisdom for all ages, but especially so in these last days.

In order to eat to live, we need to eat living food, and living food does not generally come processed in a box. Reject the foolishness of man’s wisdom and its culture of death, and take advantage of the wonderful diversity of nutrient dense, organic foods that God has made readily available.

Granted, this is easier said than done, as man’s greed has corrupted all of our food sources to some extent through factory farming, genetic engineering and the indiscriminate use of hormones, pesticides, herbicides, fungicides, antibiotics, and a host of other synthetic chemicals that are ever escalating our toxic burden. It is no wonder that so many people suffer from chronic degenerative illnesses, the symptoms of which are the body’s way of revealing a compromised bioterrain within.

This is where Logos Nutritionals and the Burgstiner Wellness Protocol can make such a profound difference in one’s quality of life. The authentic natural medicines that we offer are designed to strengthen the body’s detoxification pathways, restore the integrity of organ systems and revitalize cellular energy and immunity. My father once pointed out to me that “Man turns to excellence just as surely as a flower to the sun”. This is true, whether in the beauty of the arts, the dependable efficacy of a nutritional supplement, or the thrill of athletic competition. We rejoice in the opportunity to serve, both through the quality of our products and the priceless impact of the message of God’s love that we share.

The three resolutions presented here are ones that must be embraced as a lifestyle if you hope to thrive during these difficult times. There are others that may be more obvious and pressing such as stopping smoking or any habit that may be holding you back from achieving your goals. Personally, having for the most part successfully internalized these big three over the years, my main resolution for this year is to write more consistently. To that end, I wholeheartedly solicit the prayers of my readers.

So here’s to 2015; may it be a year of breakthrough in your health, your attitude and your relationships!

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