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Triple-Blind Randomized Placebo-Controlled Study of the Effect of StemEnhance® on Bone Marrow Stem Cell Mobilization

AIM OF THE STUDY
A triple-blinded, randomized, placebo-controlled study on human subjects was conducted on the effect of AFA extracts on the number of circulating stem cells.


METHODS

Consumables
Volunteers were fed one gram of a blend of two AFA extracts (StemEnhance® – SE), and a placebo (Ctrl).

Volunteers
A total of 15 healthy volunteers were selected using the following exclusion criteria:

* Under 20 or over 65 years of age
* Pregnancy
* Severe asthma and allergies requiring daily medication
* Any known chronic illness or previous/current venereal disease
* Frequent recreational drug use
* Impaired digestive function (including previous major gastrointestinal surgery).

Upon arrival, the volunteers were seated in quiet areas and instructed to remain quiescent, comfortably sitting in a chair, for one hour. Immediately after drawing the baseline sample, a consumable was provided. The volunteers were instructed to remain quiescent for the whole duration of the experiment. Blood samples were later drawn 30, 60 and 120 minutes after ingestion of the consumable.

Assessment of circulating stem cells
At each time point, 5 ml blood was drawn into heparin, and 2 ml blood was drawn into EDTA. One sample was used to perform a complete blood count (CBC) while the other sample was prepared for immunostaining (CD34, CD45 and CD14) and flow cytometry. Flowcytometry and data analyses were done blindly. Data is expressed as mean ± SE.


RESULTS

Consumption of SE led to an increase in the number of circulating CD34+ cells, while consumption of the placebo did not lead to any statistically significant effect.

Since the overall time for the absorption of bioactive compounds, delivery to target organs, and the generation a quantifiable physiological response may be different depending on each volunteer’s overall physiology, we calculated the maximum response of SE at any one point in time, within 60 minutes of consumption. We found a 24 ± 5 % increase (median = 27%) in the number of circulating stem cells with SE. If we include data obtained during a dose study performed in May 2005, the average maximum response raises to 30 ± 6%.




Figure 1. Time course of the number of CD34+ cells in peripheral blood after consumption (arrow) of SE and placebo (Crtl). Data are expressed as % of starting value. Bars express standard error.

DISCUSSION

This study confirmed that SE is effective at supporting the release of stem cells from the bone marrow, increasing the number of circulating stem cells (CD34+ cells). The data collected show that SE increases the number of circulating stem cells by up to 30%.

Physiological relevance of the observed stem cell mobilization
In this study the average number of lymphocytes was 1,978 per µL and the average proportion of CD34+ cells at time 0 was 0.12%, for an average number of circulating CD34+ cells of 2.4 per µL. An increase of 25% to 30%, as seen in this study, translates to an average increase of 0.7 stem cells per µL, i.e. from 2.4 to 3.1 stem cells per µL. Assuming 5.0 liters of blood, this corresponds to approximately 3.5 million new circulating stem cells. The novelty of the concept of using endogenous release of bone marrow stem cells to support optimal health is paralleled by a scarcity of data linking the magnitude of mobilization with physiological relevance. Nevertheless, data exist to estimate the physiological relevance of putting into circulation 3.5 million new stem cells. Based on various studies (Orlic et al. 2001; Bodine et al., 1994; Bodine et al. 1993; Vandelverde et al., 2005; Valgimigli et al., 2005) one can estimate that one gram of StemEnhance® can lead to potentially of up to a few billion somatic cells in target tissues. Therefore the average increase of 25% to 30% obtained with SE in this study is likely to have physiological relevance.


REFERENCES

Bodine DM, Seidel NE, Gale MS, Nienhuis AW, and. (1994) Efficient Retrovirus Transduction of Mouse Pluripotent Hematopoietic Stem Cells Mobilized Into the Peripheral Blood by Treatment With Granulocyte Colony-Stimulating Factor and Stem Cell Factor. Blood, 84(5): 1482-1491.

Bodine DM, Seidel NE, Zsebo KM, and Orlic D. (1993) In Vivo Administration of Stem Cell Factor to Mice Increases the Absolute Number of Pluripotent Hematopoietic Stem Cells. Blood, 82(2): 445- 455.

Orlic D, Kajstura J, Chimenti S, Bodine DM, Leri A. & Anversa P. (2003) Bone marrow stem cells regenerate infarcted myocardium. Pediatr Transplantation 7 (Suppl. 3): 86–88.

Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A. & Anversa P. (2001) Mobilized bone marrow cells repair the infracted heart, improving function and survival. PNAS 98(18):10344–10349.

Valgimigli M, Rigolin GM, Cittanti C, Malagutti P, Curello S, Percoco G, Bugli AM, Porta MD, Bragotti LZ, Ansani L, Mauro E, Lanfranchi A, Giganti M, Feggi L, Castoldi G, Ferrari R. (2005) Use of granulocyte-colony stimulating factor during acute myocardial infarction to enhance bone marrow stem cell mobilization in humans: clinical and angiographic safety profile. Eur Heart J. Apr 28. Epub.

Vandervelde S, van Luyn MJ, Tio RA, Harmsen MC. (2005) Signaling factors in stem cell-mediated repair of infarcted myocardium. J Mol Cell Cardiol. Jun 28. Epub.

Adult stem cells cure diabetes in mice

Adult stem cells have a major role to play in curing type 1 diabetic mice, according to a new study by an Indian-origin scientist.

In the study, the researchers focussed on a study by Dr. Lawrence C.B. Chan and colleagues in his Baylor College of Medicine laboratory, in which they cured mice with type 1 diabetes by using a gene to induce liver cells to make insulin.

“Now we know how it works. The answer is adult stem cells,” said Chan.

Chan and Dr. Vijay Yechoor, assistant professor of medicine-endocrinology and first author of the report, said that a gene called neurogenin3 proved critical to inducing cells in the liver to produce insulin on a continuing basis.

They used a disarmed virus called a vector to deliver the gene to the livers of diabetic mice by a procedure commonly known as gene therapy.

“The mice responded within a week,” said Yechoor.

The levels of sugar in their blood plummeted to normal and stayed that way for the rest of their normal lives, and this quick response generated more questions as did the length of time that the animals stayed healthy.

Yechoor found that there was a two-step response-firstly, the neurogenin3 gene goes into the mature liver cells and causes them to make small quantities of insulin - enough to drop sugar levels to normal,.

“This is a transient effect. Liver cells lose the capacity to make insulin after about six weeks,” he said.

But, they found that other cells that made larger quantities of insulin showed up later, clustered around the portal veins (blood vessels that carry blood from the intestines and abdominal organs to the liver).

“They look similar to normal pancreatic islet cells (that make insulin normally),” said Yechoor.

Also, they discovered that these “islet” cells came from a small population of adult stem cells usually found near the portal vein.

Only a few are needed usually because they serve as a safety net in case of liver injury. When that occurs, they quickly activate to form mature liver cells or bile duct cells.

However, neurogenin3 changes their fates, directing them down a path to becoming insulin-producing islet cells located in the liver.

The mature liver cell cannot make this change because its fate appears to be fixed before exposure to neurogenin3.

Yechoor said that the islet cells in the liver were quite similar to those made by pancreas after an injury.

“If we didn’t use neurogenin3, none of this would happen. Neurogenin3 is necessary and sufficient to produce these changes,” he said.

Chan cautioned that much more work is needed before similar results could be seen in humans.

“The concept is important because we can induce normal adult stem cells to acquire a new cell fate. It might even be applicable to regenerating other organs or tissues using a different gene from other types of adult stem cells,” he said.

The study appears in the journal Developmental Cell. (ANI)

What are adult stem cells?



An adult stem cell is thought to be an undifferentiated cell, found among differentiated cells in a tissue or organ that can renew itself and can differentiate to yield some or all of the major specialized cell types of the tissue or organ. The primary roles of adult stem cells in a living organism are to maintain and repair the tissue in which they are found. Scientists also use the term somatic stem cell instead of adult stem cell, where somatic refers to cells of the body (not the germ cells, sperm or eggs). Unlike embryonic stem cells, which are defined by their origin (the inner cell mass of the blastocyst), the origin of adult stem cells in some mature tissues is still under investigation.

Research on adult stem cells has generated a great deal of excitement. Scientists have found adult stem cells in many more tissues than they once thought possible. This finding has led researchers and clinicians to ask whether adult stem cells could be used for transplants. In fact, adult hematopoietic, or blood-forming, stem cells from bone marrow have been used in transplants for 40 years. Scientists now have evidence that stem cells exist in the brain and the heart. If the differentiation of adult stem cells can be controlled in the laboratory, these cells may become the basis of transplantation-based therapies.

The history of research on adult stem cells began about 50 years ago. In the 1950s, researchers discovered that the bone marrow contains at least two kinds of stem cells. One population, called hematopoietic stem cells, forms all the types of blood cells in the body. A second population, called bone marrow stromal stem cells (also called mesenchymal stem cells, or skeletal stem cells by some), were discovered a few years later. These non-hematopoietic stem cells make up a small proportion of the stromal cell population in the bone marrow, and can generate bone, cartilage, fat, cells that support the formation of blood, and fibrous connective tissue.

In the 1960s, scientists who were studying rats discovered two regions of the brain that contained dividing cells that ultimately become nerve cells. Despite these reports, most scientists believed that the adult brain could not generate new nerve cells. It was not until the 1990s that scientists agreed that the adult brain does contain stem cells that are able to generate the brain's three major cell types—astrocytes and oligodendrocytes, which are non-neuronal cells, and neurons, or nerve cells.

Adult Stem Cell Research Study Provides Hope for Kidney, Liver Patients

by Steven Ertelt
LifeNews.com Editor
September 6, 2006


Florence, Italy (LifeNews.com) -- Italian scientists have made advances in adult stem cell research that may provide new hope for patients suffering from liver or kidney diseases. The research team has identified kidney stem cells that helped kidneys repair themselves and the discovery could lead to new treatments.
A team led by top immunologist Sergio Romagnani said the new kidney cells appear to be able to turn into an array of other cells in the body.

"Chronic renal diseases and terminal renal insufficiency are viewed as the medical emergency of the new century," Romagnani told a press conference, according to the ANSA Italian news agency.

He said the team found that the adult stem cells repaired kidney damage in the mice used in the study. That's important because current treatments merely slow the disease but don't repair damage it causes.

"This is particularly important because the drugs we currently have are only able to slow down kidney damage," he said, according to the ANSA report.

Because the cells can differentiate into bone cells, adipose (fatty tissue) cells and even nerve cells there is hope of helping to reverse degenerative diseases in those areas as well, he explained.

The team published the results of their new studies in the Journal of the American Society of Nephrology.

Meanwhile, one day after Romagnani's press conference, a team in Turin announced, in the latest edition of the journal Stem Cells, that the adult kidney cells are able to become pluripotent.

"The progenitor cells identified by our team are able to differentiate into liver cells, bone cells, blood cells and even pancreatic cells that produce insulin," lead researcher Benedetta Bussolati told ANSA.

"The diffentiating capacity of these cells holds promise that they can be used in regenerative medicine such as cell therapy, an alternative to the use of embryonic stem cells," she said.

The studies show another alternative to embryonic stem cell research, which involves the destruction of human life.

VIDEO : Stem Cell Therapy for Type II Diabetes

TESTIMONIAL : ASC Can Help for High Blood Pressure

Ann Stahler
I have had high blood pressure since my teens. I've had many health problems throughout my life and although I was able to get most under control my blood pressure continued to be high. Without drugs my blood pressure runs 200/140-150. My goal has always been to say goodbye to prescription drugs.

I had been searching for something that might help me get off the blood pressure medications because they are breaking down my body. Then, about four months ago, I was introduced to stem cell nutrition. I was still taking a lot of blood pressure medication at that time.

After taking the stem cell nutrition, I have been able to eliminate about 30 percent of the blood pressure medicine. My blood pressure is now usually 130/80. I’ve noticed a significant improvement in my digestion and elimination. Also, my muscles feel more relaxed and I sleep better at night. Stem cell nutrition is a very important part of my health maintenance program. I am thankful my friend introduced it to me.

TESTIMONIAL : Adult Stem Cell May Treat Diabetes

Adult stem cells from human bone marrow may help treat type 2 diabetes.

That’s the early finding from lab tests on diabetic mice. Tests on people haven’t been done.

The mouse studies are summed up in the Proceedings of the National Academy of Sciences.

Researchers included biochemistry professor Darwin Prockop, MD, PhD, who directs Tulane University’s Center for Gene Therapy.

The researchers studied male mice with high blood sugar like that in type 2 diabetes.

Half the mice received two injections of adult stem cells taken from human bone marrow. With their defective immune systems, the mice didn’t reject the human cells.

For comparison, the other mice didn’t get any injections.

Over the next month or so, mice treated with stem cells made more insulin, a hormone that controls blood sugar.

Stem cells turned up in the mice’s pancreas, which makes insulin.

The stem-cell treated mice also had less kidney damage than mice in the comparison group, the study shows.

Diabetes can cause kidney damage. Stem cells showed up in the mice’s kidneys as well; the injected cells may have helped repair damage, the researchers say.

It’s possible, but not yet certain, that stem cell shots could boost insulin production and help fix damaged tissue in people with diabetes, according to Prockop’s team.


SOURCES: Lee, R. Proceedings of the National Academy of Sciences, Nov. 14, 2006; vol 103: pp 17438-17443. News release, Tulane University. News release, Proceedings of the National Academy of Sciences.

Gerrit Woning - Personal Story

I am sixty-eight years old and have uncontrollable diabetes. Fifty units of insulin three to five times a day couldn’t keep my blood sugar level normal. It would soar over 300, and the insulin could only bring it down the mid-200 range. I developed high blood pressure and was losing my eyesight from my unstable blood sugar. After ten days on stem cell nutrition, I was able to bring my blood sugar level down to 150 to 160.

After six weeks, I could control my sugar levels at 120 to 140 with less than 30 units of insulin. Within eight weeks, I didn’t need to take insulin anymore.

Since then, I can maintain normal blood sugar levels without medication. My vision cleared and the floaters in my eyes are completely gone. My blood pressure, which was 212/150, is now down to 110/60.

I also suffer from arthritis. I have been a professional soccer player in the Netherlands where I injured my knees. Later, in my handyman business, I had trouble using step ladders to install ceiling fans and the like. I would have so much swelling and pain in my knees, that I would have to literally crawl up the steps to get home.

Six weeks after starting the stem cell nutrition, I went off pain medication totally. The swelling went down, and it looks as though I have soccer legs back.

The other day I was "carded” for my Senior Citizens Discount at a restaurant! I feel like I’m 39 or younger! My hair is even turning back to its natural color.

Stem cell nutrition has revolutionized my life. I feel like I am physically reborn.

Adult Stem Cell Studies



From the National Institutes of Health we learn that:

"Adult stem cells have been identified in many organs and tissues. One important point to understand about adult stem cells is that there are a very small number of stem cells in each tissue. Stem cells are thought to reside in a specific area of each tissue where they may remain quiescent (non-dividing) for many years until they are activated by disease or tissue injury. The adult tissues reported to contain stem cells include brain, bone marrow, peripheral blood, blood vessels, skeletal muscle, skin and liver.

Scientists in many laboratories are trying to find ways to grow adult stem cells in cell culture and manipulate them to generate specific cell types so they can be used to treat injury or disease. Some examples of potential treatments include replacing the dopamine-producing cells in the brains of Parkinson's patients, developing insulin-producing cells for type I diabetes and repairing damaged heart muscle following a heart attack with cardiac muscle cells.

Also, a single adult stem cell should be able to generate a line of genetically identical cells—known as a clone—which then gives rise to all the appropriate differentiated cell types of the tissue. Scientists tend to show either that a stem cell can give rise to a clone of cells in cell culture, or that a purified population of candidate stem cells can repopulate the tissue after transplant into an animal. Recently, by infecting adult stem cells with a virus that gives a unique identifier to each individual cell, scientists have been able to demonstrate that individual adult stem cell clones have the ability to repopulate injured tissues in a living animal.

As indicated above, scientists have reported that adult stem cells occur in many tissues and that they enter normal differentiation pathways to form the specialized cell types of the tissue in which they reside. Adult stem cells may also exhibit the ability to form specialized cell types of other tissues, which is known as transdifferentiation or plasticity.

Normal differentiation pathways of adult stem cells. In a living animal, adult stem cells can divide for a long period and can give rise to mature cell types that have characteristic shapes and specialized structures and functions of a particular tissue."

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Source : http://www.earthbornwellness.com/studies.htm

Watch Video - Adult Stem Cell Enhance AFA Enhance Stem Cells Naturally



How does Stem Enhancer work?

When you take 2 capsules of StemEnhance®, the ingredients help support the release of stem cells from the bone marrow into the bloodstream. Through a natural process, those stem cells then travel to areas of the body where they are most needed. According to research, 1 gram of StemEnhance® equals 2 capsules, which triggers a 25-30% increase in the number of circulating stem cells ( 3-4 million additional stem cells ).
Tests conducted by the Center for Preventive Doping Research in Cologne, Germany found StemEnhance to be free of anabolic steroids and stimulants.

WHAT IS STEMENHANCER?

What are stem cell enhancers? Recent scientific developments have revealed that stem cells derived from the bone marrow, travel throughout the body, and act to support optimal organ and tissue function. Stem cell enhancers are products that support the natural role of adult stem cells.

According to the New England Journal of Medicine, the number of stem cells circulating in the blood stream is one of the best indicators of health. Traditional health supplements nourish existing cells; they do not renew tissues. For those of us just wanting to maintain optimal health or assist the body in the process of aging, or day to day wear and tear, a steady release of our existing stem cells into the blood stream can produce considerable health benefits.

Stem Enhance a natural botanical extract, is a breakthrough PATENTED product that supports the release of your own adult stem cells from your bone marrow into your bloodstream. The resulting increase in the number of circulating adult stem cells - up to 30% - can greatly assist your body's natural ability to maintain youthfulness, vitality and optimal health!

When StemEnhance is used as a daily supplement over time, the circulation of millions of additional stem cells in the bloodstream could be one of the safest and most efficient methods for maintaining optimal health that science has yet discovered.

Stem Cell Enhancers support the natural release of Adult Stem Cells from our own bone marrow. The only stem cell enhancer available is a natural botanical extract. It is a blend of 2 compounds extracted from the cyanophyta Aphanizomenon Flos – aquae (AFA)…blue green algae in Klamath Lake. These compounds are extracted using a proprietary process that utilizes no chemicals, or harsh agents and is highly concentrated in the product.
One extract contains an L-selectin ligand, which supports the release of stem cells (CD34+cells) from the bone marrow. The other extract a polysaccharide-rich fraction named MigratoseTM, supports the migration of stem cells to tissue in the body needing repair.

StemEnhance® is a blend of two compounds extracted from the cyanophyta Aphanizomenon flos-aquae (AFA). These compounds are extracted using a proprietary process that utilizes no chemicals or harsh agents.


One extract, which contains an L-selectin ligand, supports the release of stem cells (CD34+ cells) from the bone marrow. The other extract, a polysaccharide-rich fraction named Migratose™, may support the migration of stem cells out of the blood into tissues.

Stem cell trials give diabetics reason for hope

Human trials under way at the University of Miami and other hospitals in Europe, Asia and Latin America using immature adult stem cells are showing promise for people with type 2 diabetes.

In a UM clinical trial recently published in the online journal Cell Transplantation, 25 patients achieved better insulin production, lower blood-sugar levels and reduced need for insulin injections.

In the trial, still in its pilot stage, doctors extracted immature adult stem cells from the patients’ own bone marrow, purified and concentrated them, and injected them into arteries near the pancreas. They then put the patients into hyperbaric oxygen chambers like those used for divers with decompression sickness — also called the ”bends” — and subjected them to 10 hours of pure oxygen at 2.4 times the atmospheric pressure at ground level.

Researchers believe the high-pressure oxygen pulled extra stem cells from the patients’ bone marrow, adding to the stem cells injected near the pancreas. They say the immature stem cells developed into pancreatic cells, regenerating the pancreas’ ability to produce natural insulin.

”This could be very important,” said Dr. Camillo Ricordi, director of the Cell Transplant Center and the Diabetes Research Institute at UM. “It could be an improved treatment for diabetes, substantially ameliorating type 2 and preventing the complications of the disease.”

Nearly 8 percent of the U.S. population — 24 million people — has diabetes, which can cause problems for the eyes, kidneys, nerves and heart, according to the Centers for Disease Control and Prevention.

Ricordi cautioned that the optimistic findings come from small pilot studies involving only dozens of patients, and three to four more years of research are needed before practical treatments might start.

”We always have to avoid hype and be careful not to put too much hope in pilot trials,” Ricordi said. “But the first results are really promising.”

Two more successful trials over three or four years would be needed before the FDA might approve the treatment. The studies, coordinated by UM’s Diabetes Research Institute, will also take place at the Karolinska Institutet in Stockholm, Stem Cell Argentina in Buenos Aires and other institutions.

Source: Miami Herald
Other articles and science reports on Adult Stem Cells.
Check, E., Cardiologists take heart from stem-cell treatment success, Nature 428(6986):880, 29 April 2004: "Adult stem cells have long been viewed as less flexible than embryonic stem cells, which can divide to produce any cell type in the body. But recent studies of human cells suggest that adult stem cells can also turn into many cell types, including heart, brain and liver cells."

Terada, N. et al., Bone marrow cells adopt the phenotype of other cells by spontaneous cells fusion, Nature (416(6880):542–545, 4 April 2002.

Cohen, P., Stem cells could save sight, New Scientist 175:(2354):18, 3 August 2002.

Stem cells do their stuff for Parkinson’s patient, New Scientist 174(2338):5, 13 April 2002.

Randerson, J., Stem cells fix the damage, New Scientist 177(2377):14, 11 January 2003.

Pluchino, S. et al., Injection of adult neurospheres induces recovery in a chronic model of multiple sclerosis, Nature 422(6933):688–694, 17 April 2003.

Jochen Ringe et al., Stem cells for regenerative medicine: advances in the engineering of tissues and organs, Naturwissenschaften 89(8), August 2002.

About the Formulator of StemEnhance - Christian Drapeau
Mr. Drapeau, a foremost scientist in the study of Aphanizomenon flos-aquae, holds a Masters of Science degree in Neurology and Neurosurgery from the Montreal Neurological Institute, an affiliate of McGill University in Montreal, Quebec, Canada. He has been extensively involved in the study of nutrition, naturopathy, and various natural therapies.

Most significantly, Mr. Drapeau collaborated with many scientists affiliated with Harvard University, McGill University, the University of Illinois, Oregon State University, the University of New Mexico, and the University of Mississippi in the study of the effects of blue-green algae (Aphanizomenon flos-aquae) on human health. Mr. Drapeau continues his involvement in the clinical study of AFA.

Circulating stem cells can reach various organs and become cells of that organ, helping such organ regain and maintain optimal health. Recent studies have suggested that the number of circulating stem cells is a key factor; the higher the number of circulating stem cells the greater is the ability of the body at healing itself. What happens to stem cells if they do not reach a tissue? Stem cells released from the bone marrow that do not reach a tissue simply return to the bone marrow after some time

United States Patent Patent No.: 6,814,961 B1 Date of Patent: November 9, 2004 Subj: METHOD FOR ENHANCING STEM CELL PHYSIOLOGY Inventors: Gitte S. Jensen and Christian Drapeau