Archive for the ‘News From Logos Nutritionals’ Category

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.

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Logos is in the News!

0Candida Rid pic Logos Nutritionals Launches New "Candida Rid – Yahoo! News
Read ‘Logos Nutritionals Launches New "Candida Rid" Antifungal Supplement to Fight Yeast Infections & Candida Overgrowth’ on Yahoo! News. Proprietary
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Logos is in the News!

Logos Nutritionals  just announced an Online Sweepstakes Promotion called “Win a Year’s Supply of Health” that runs from now until June 30.  You can win $50 weekly drawings or the Grand Prize worth $500… no purchase necessary. 

To check it out, go to the Logos Home Page and click on the sweepstakes banner.

Logos Nutritionals 2010 Review and Look Ahead

As I look back and reflect on the year 2010, I am very thankful for God’s provision and grace in the midst of such a difficult economy.  Like most companies that survived last year,  Logos did not experience tremendous revenue growth, but we made significant strides forward in strengthening our ability to serve you and in preparing for the rapid growth we anticipate this year.

Some of last year’s outstanding accomplishments were:

1.    Product Improvement and Development remained a priority. 
•    Liver CS Plus was reformulated from a tablet to a capsule and the prized detoxification formula was even further improved with the addition of N-Acetyl Cysteine. 
•    Monolaurin, a potent antiviral/antimicrobial extract derived from coconuts was added to our line of authentic natural medicines. 
•    The Burgstiner Wellness Protocol Trial/Travel Packs (one week supply of individual dose packets) were introduced with such success that we are now working on a
Thirty Day Supply Pack.
•     Several other projects were begun that will soon be introduced, such as a revolutionary new sleep formula, a new thymic formula in capsules, and a groundbreaking new cardiovascular health formula.

 2.    Developing our customer service potential remained a priority.
•    Negotiated strategic agreements with suppliers to streamline inventory control and supply chain functions to allow for unimpeded growth.
•    Enhanced fulfillment capabilities – scalable for growth.
•    Upgraded Internal Communications system.
•    Discovered and repaired design flaws in company website to improve customer experience and organic search visibility.

3.    Marketing and Communications remained a priority.
•    The Logos Website Continues to grow – (Nearly 600,000 unique visitors last year, 77% of them new)
•    Developed Social Media Outreach Program including this blog, published articles, a Facebook Page and most recently, a Twitter Page and Broadcast Feed.
•    Thanks to you, the word is getting out about Logos!

In these difficult economic times, every business must necessarily concern itself with market share and the bottom line, but regardless of how large it grows, Logos will always measure its success by the impact it has in the lives of its employees, vendors and especially its customers.
 
We look forward to the challenges and opportunities of 2011 with great anticipation.  We plan to continue expansion of our product line and web presence, and build quality relationships with medical practitioners who can help document and validate the efficacy of our amazing products.  Most of all, we look forward to continuing to serve you.

On behalf of our entire team at Logos Nutritionals, we thank you again for your loyal support!

Diabetes and Insulin Resistance Linked to Gut Flora in Study of Obese Patients

redbacteria2 Diabetes and insulin resistance were linked to gut flora in a rather unusual study recently reported on at the European Association for the Study of Diabetes Meeting in Stockholm, Sweden. In the study, insulin sensitivity in obese patients with a set of symptoms known as metabolic syndrome (prediabetes) was improved with a fecal transplant from thin donors.

Yes, you read that correctly… I said a fecal transplant from thin donors!

According to Anne Vrieze MD and colleagues of the Academic Medical Center in Amsterdam, after six weeks, peripheral insulin sensitivity significantly improved in 18 patients who received feces from lean donors compared with those who received an autologous (self-provided) transplant (P<o.o5).

“This confirms the potential role of gut microbiota in the disturbance of glucose and lipid metabolism in obesity,” Vrieze said during the presentation. “The challenge is to use this knowledge to develop therapies.”

Umm, May I make a suggestion?  PROBIOTICS… especially broad spectrum, high potency probiotics like Essential Flora.  This is not the first study to link diabetes, insulin resistance and obesity to inadequate levels of beneficial bacteria in the GI tract.

Digestive health and immune system integrity depend in large measure on the balance of power in the gut.  We know that the gut plays a major role in immunity (it is said that 80% of our immune cells are found in the gut) and in regulating hormones that impact both obesity and diabetes that is linked to obesity.

While fecal transplantation programs are certainly not common, the idea is being investigated in the U.S. based upon reports of successful treatments with chronic GI tract infections involving the bacteria Clostridium difficile.

Studies in animals have also demonstrated a link between gut flora and obesity, “…as animals given bacteria from the feces of obese mice had a significantly greater increase in total body fat than those colonized with a “lean” microbiota”, Vrieze said.

The researchers saw increased inflammation in both groups following transplant, and cytokines are currently being analyzed. Bacteria from the jejunum are also in the process of being assessed to determine specific changes to the gut flora.

From this research, it appears that there is a significant difference in the gut flora of thin and obese individuals. It is not yet clearly understood how certain bacteria seem to be able to trigger genes that influence insulin metabolism and obesity, but there is certainly a growing mountain of evidence for the importance of probiotics in the diet and as a foundational natural health supplement.

Naturopathic physicians who are presented with a patient with diabetes or metabolic syndrome will always start with probiotics because they are so fundamental to digestive and immune health.  Enhancing insulin sensitivity and controlling inflammation are helpful to all of us, but especially to those who are predisposed to diabetes.

Primary source: European Association for the Study of Diabetes
Source reference:
Vrieze A, et al “Metabolic effects of transplanting gut microbiota from lean donors to subjects with metabolic syndrome” EASD 2010; Abstract 90.

Logos Announces Bioenergetic Product Test Kits

IMG_0641 Many medical practitioners today use various biofeedback tools and techniques to help diagnose and treat their patients. Some use muscle testing or kinesiology while others use electrodermal screening or other computerized means of receiving valuable feedback from the body.

Whether they are using natural or computer assisted biofeedback techniques, our new Logos Nutritionals Bioenergetic Product Test Kit will prove very useful in assessing and addressing the nutritional needs of their patients.

Bioenergetic Practitioners can order a test kit by calling Logos Customer Service at (800)556-5530. With their kit they will also receive a copy of the Logos Product Information Guide or company catalog, which contains brief product descriptions and ingredients of each of our outstanding natural medicines. Individual Product Specification Sheets are also available online on the Catalog and Product Spec Sheets page of our website (as is the catalog).

Bioenergetic testing allows practitioners to tailor their nutritional support recommendations based upon the unique requirements of the patient. Every Logos formula is represented in the test kit. Each sample vial contains ingredients equivalent to one (1) capsule, caplet or gelcap, and is intended for testing only. The vials are organized in the same order as they appear within each section of the catalog, and inside the lid is a convenient codex to help keep the formulas organized.

IMG_0649 The six foundational health formulas that make up the Burgstiner Wellness Protocol (pages 4 and 5 of catalog) appear first followed by a sample pack containing the entire protocol. Our Sports Nutrition formulas (page 11), which are also powerful natural medicines in their own right, appear next. The bottom row includes each of our Other Foundational Health Products (pages 8-10).

We are very excited about making the test kits available, and we thank our practitioners for giving Logos the opportunity to help you have an even greater impact on the quality of life of your patients. We are very interested in your feedback. Please feel free to contact me directly with any questions, comments or suggestions.

If you are a patient of a Bioenergetic Practitioner, please consider blessing their practice and their other patients by passing this information along to them.

Is Wasp Spray Better Self Defense Than Pepper Spray?

wasp spray According to a popular urban legend, a woman who worked as a church receptionist in  a high risk area was concerned about someone coming into the office on Monday to rob them when they were counting the collection. She asked the local police department about using pepper spray and they recommended to her that she get a can of wasp spray instead.

The wasp spray, they told her, can shoot up to twenty feet away and is a lot more accurate, while with the pepper spray, they have to get too close to you and could overpower you. The wasp spray temporarily blinds an attacker until they get to the hospital for an antidote.

She keeps a can on her desk in the office and it doesn’t attract attention from people like a can of pepper spray would. She also keeps one nearby at home for home protection.

Val Glinka teaches self-defense to students at Sylvania Southview High School . For decades, he’s suggested putting a can of wasp and hornet spray near your door or bed. Glinka says, “This is better than anything I can teach them.”

Glinka considers it inexpensive, easy to find, and more effective than mace or pepper spray. “If someone tries to break into your home”, Glinka says, “spray the culprit in the eyes”. It’s a tip he’s given to students for decades.

It’s also one he wants everyone to hear. If you’re looking for protection, Glinka says look to the spray. “That’s going to give you a chance to call the police; maybe get out.  Maybe even save a life. “

However, some have advised against using wasp spray as an alternative to pepper spray, primarily for two reasons:

  1. The active ingredient in most wasp sprays are pyrethrins, compounds derived from the chrysanthemum plant which penetrate the nervous system of insects and kill them.  Wasp sprays are not formulated to be used directly on humans, and their safety and effectiveness for that purpose has not been tested.  They may inflict far more serious long term harm than pepper spray does.
  2. Many jurisdictions specifically prohibit the use of any self-defense sprays other than pepper spray.  Additionally, most spray insecticide containers include warnings stating that “It is a violation of federal law to use this product in a manner inconsistent with its labeling”.

While pepper spray is far less conspicuous as a potential weapon, it may in fact be much more dangerous to both the attacker and the victim as well as any innocent bystanders.  Given the potential legal liabilities involved with the use of wasp spray, I think I will stick with pepper spray… and a baseball bat.

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