Research

Triple-Blind Randomized Placebo
Controlled Study of the Effect of
StemEnhance™ on Bone Marrow
Stem Cell Mobilization.ą
By Christian Drapeau, MSc.

1. This is a summary of a full-length study report prepared for publication in the peer-review scientific literature.

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.

ABOUT CHRISTIAN DRAPEAU, MSc
Christian Drapeau MSc, Chief Science Officer of StemTech Health Sciences, Inc. Mr. Drapeau is an author, research scientist and neurophysiologist with over thirteen years of research experience in the fields of natural foods and nutrition.Mr.Drapeau has been the Director of Research at Desert Lake Technologies since 2000, pursuing scientific research in collaboration with various universities and research centers on the health benefits of certain botanical raw materials.

Based on research he produced, and information he researched from other various scientific teams, Mr. Drapeau and his collaborators recently proposed and published a breakthrough theory on adult stem cell physiology, and is the co-inventor of StemEnhance™. Mr. Drapeau received a bachelor’s degree in Neurophysiology from McGill University, Montreal, in 1987 and a master’s degree from the Department of Neurology and Neurosurgery from the Montreal Neurological Institute, McGill University, Montreal, in 1991.


Mobilization of human CD34+CD133+ and CD34+CD133- stem cells in vivo by consumption of an extract from Aphanizomenon flos-aquae related to modulation of CXCR4 expression by an L-selectin liguand?

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Further Research

(Collected from research articles, science papers and medical publications).

Stem Cells From Muscles Can Repair Cartilage

The President's Council on Bioethics: Adult Stem Cells

Stem Cell Therapy in Perspective

Clinical Applications of Blood-Derived and Marrow-Derived Stem Cells for Nonmalignant Diseases. JAMA Vol. 299 No. 8, February 27, 2008

Bone marrow stem cells can participate in cutaneous healing, contributing to wound healing - Journal of Cellular Physiology 196, 245-250; 2003

Stem cells participate in the generation of new neurons within the human brain - Proceedings of the National Academy of Sciences USA 100, 1364-1369; 4 Feb 2003

Mobilized stem cells have also been used in renewal of cardiac tissue - Journal of Clinical Investigation 107, 1395-1402; Jun 2001

Bone marrow stem cells have also shown the ability to participate in renewal of retinal tissues - Nature Medicine 8, 1004-1010; Sep 2002


StemEnhance™ Patent Information

[One patent has been issued on StemEnhance and another one has been filed. The issued patent is a Use Patent that pertains to the use of AFA for supporting stem cell physiology. The second patent is a Composition Patent that pertains to the specific components in AFA responsible for stem cell support.]

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

For details, download (PDF):
Method for Enhancing Stem Cell Physiology, US Patent No. 6,814,961 B1
(To download, right-click on the link, choose 'Save Target (or Link) As,' and save into your computer.)


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** Neither StemTech Health Sciences Inc. nor its distributors make or infer any claims that StemEnhance™ can cure, mitigate, treat or prevent any disease.