Are There Any Safety Concerns with StemEnhance™?

Natural support for your body's own innate renewal system.

StemEnhance™: all-natural adult stem cell enhancer.

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60 capsules, 500mg each

Price:  $59.95

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Learn more about StemEnhance™.

StemEnhance™ is the first product of its kind on the market, creating a new category of phytoceuticals called "stem cell enhancers".  Because of its newness, there can be legitimate questions about the safety of this product.  Dr. Stephen Barrett (see a related article about him here) has also posted an article online that raises doubts about StemEnhance™ and stem cell enhancers.

While not a detailed response to Dr. Barrett, I hope that what follows here will answer any concerns you might have about the safety of StemEnhance™ for your own use.

Is StemEnhance™ FDA approved?

When considering the safety and effectiveness of any product, the first question that many people ask is: "Is this product FDA approved?"  But, while it may sound like a reasonable question to ask, it misses the point on a few key issues.

• First of all, the FDA does not approve dietary supplements in the way that it approves some drugs and medical devices.  Under American law (DSHEA), supplements are foods and, as such, are not subject to FDA approval.
• As we have clearly seen with Vioxx^® — and many other pharmaceuticals in recent years — FDA approval isn't a guarantee of either safety or effectiveness.

And so, the lack of FDA approval, in and of itself, should not raise questions about the safety of any product.

That said, StemEnhance™ has not been approved by the FDA.  It's a supplement, and not subject to such regulation.  However, the FDA does regulate product quality, product safety and product claims, and has the authority to remove products from the market that are not safe, or that make claims that are not substantiated by scientific evidence.  STEMTech HealthSciences, Inc has met all the FDA's requirements in this regard.

And, unlike most FDA-approved pharmaceuticals, AFA has been widely-used for over 20 years, with a very good safety record.

Is it safe to increase the release of stem cells into circulation over the long-term?

This is an excellent question, and can be answered from two perspectives:

1. The depletion of adult stem cells in the bone marrow, and
2. The volume of stem cells in the body.

The question of depletion:

Unless you understand the physiology of stem cells, the idea of stimulating the release of up to 25-30% more adult stem cells from the bone marrow raises some concerns about long-term safety.  But in reality, there is nothing about this to cause such concerns.  The safety is unquestionable.

First of all, increasing the rate at which stem cells are released into the bloodstream will not deplete the bone marrow.

Your bone marrow is constantly producing new stem cells, throughout your entire life-span.  They are responsible for the on-going renewal of red blood cells and lymphocytes (immune cells).  Furthermore, stem cells that don't reach any tissue or become blood cells are essentially recycled, returning to the bone marrow after some time.  Your body, with its own innate intelligence, doesn't waste them.

Not only that, but Krause et al. reported that a single stem cell was enough to reconstitute the entire hematopoietic (red blood cell) and immune systems.  If a single stem cell can do this, then the billions of stem cells left in the bone marrow after taking StemEnhance™ can maintain a healthy and strong bone marrow.

The volume of stem cells in the body:

The amount of active bone marrow in your body amounts to about 2,600 g (5.7 lbs), with about 1.5 trillion marrow cells.  The number of circulating stem cells in your body is normally between 1.2 and 5.0 stem cells per µL of blood.

An increase of 30% in the number of circulating stem cells, triggered by the consumption of 1 gram (2 capsules) of StemEnhance™, corresponds to approximately 3 million cells, which is a small portion of the stem cells present in the bone marrow, and would, at most, mean an increase of 1.5 cells per µL of blood, which is well within the normal physiological range, and does not constitute stress on the bone marrow environment.

Since StemEnhance™ is a concentrate, what is the safety of taking so much AFA?

AFA (Aphanizomenon flos-aquae), the raw ingredient from which StemEnhance™ is derived, has been widely used for more than two decades, with a very good track record of safety and health benefits.

A safety study in mice determined that consumption of the equivalent of up to 2,000 AFA capsules daily led to no health problems whatsoever.  In fact, the study's authors claimed that the mice receiving the highest dose of AFA were less aggressive, and looked healthier, than those in the control group.

StemEnhance™ is a 5:1 concentrate of AFA; and, just like 5:1 concentrates of echinacea, grape seed, ginkgo or wheat grass juice, that are as safe as the whole plant from which they are derived, StemEnhance™ is as safe as whole AFA.  It is to whole AFA what carrot juice is to a whole carrot.

Will StemEnhance™ cause abnormal growths, like cancer?

Unlike embryonic stem cells, adult stem cells, released from the bone marrow, have not been associated with abnormal growths or the development of tumors.

The release of stem cells from the bone marrow, and their migration to tissues, is a natural process that happens every day.  StemEnhance™ doesn't do anything that the body isn't already doing; it simply supports that natural process, and tips the balance toward health.

So far, no instances of cancer, or any similar problem, have ever been observed with the natural, in vivo release of adult stem cells from the bone marrow.  Abnormal cellular growth has only been seen when manipulating stem cells in vitro (in test tubes).

Who should and should not take StemEnhance™?

StemEnhance™ is for anyone interested in supporting his or her body's natural renewal system, and giving the body an extra boost toward daily renewal.  Since it supports the natural release of adult stem cells from the bone marrow, StemEnhance™ is the ideal daily support for the maintenance of optimal health.

That said: StemEnhance™ still might not be right for everyone.  In the following circumstances, StemEnhance™ might be contraindicated.

People on anticoagulant therapy:
Since one gram (2 capsules) of StemEnhance™ contains a significant amount of naturally-occurring vitamin K (roughly half of the recommended daily allowance), anyone taking anticoagulant medication should consult with his or her doctor in order to adjust the medication, if necessary.

Vitamin K is an essential nutrient, playing an important role in the process of blood coagulation.  Hence, doctors often tell people to avoid vitamin K while on anticoagulant therapy.  However, it is not so much the presence of vitamin K in the diet as much as the consistency in the daily intake that is the issue here.

Therefore, the best approach is to discuss with your doctor your desire to take StemEnhance™, and explain that it contains vitamin K.  With your doctor's careful monitoring of your condition, your anticoagulant prescription can be adjusted as needed.

People with bone marrow disease:
Also, while there have been no observations of ill effects, STEMTech's scientific team speculates that StemEnhance™ could be contraindicated for anyone having a disease of the bone marrow.

People on antidepressants or having bi-polar disorders:
StemEnhance™ might also be contraindicated for people taking antidepressants or suffering from severe manic depression.  Interactions with antidepressant medications have not been reported, but the possibility exists.  So, if you are on antidepressant medication, consult with your doctor before taking StemEnhance™.

As a 5:1 concentrate of AFA, two capsules of StemEnhance™ contain about 5 mg of phenylethylamine (PEA).  Also known as the "molecule of love" or the "molecule of joy", PEA is responsible for the immediate sense of well-being you normally experience when taking StemEnhance™.  It's a compound naturally produced by the brain whenever you feel content or happy, and it affects dopamine and norepinephrine in the brain.

PEA is known for its effect on mood elevation and mental energy, and a deficiency in PEA has been linked to problems of concentration and low mood.  Oral intake of PEA has been shown to improve these conditions.

However, because of the effect of PEA in the brain, there is the possibility of an interaction with antidepressant medications.