Triple-Blind Randomized Placebo-Controlled
Study of the Effect of StemEnhance™ on
Bone Marrow Stem Cell Mobilizationą
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
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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%.
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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.
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See also:
- Stem Cells and StemEnhance
by Christian Drapeau, MSc (video)
- Product description
- Patent Information
- The Story of StemEnhance
- Published paper in Medical Hypotheses journal
StemTech and its distributors do not make
any claims that StemEnhance can cure, mitigate, treat or prevent
any disease. If you believe that you have a health problem, see
your doctor or health professional immediately.
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