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An increase in the number of circulating adult stem cells by StemEnhance® does not
promote tumor growth.

By Christian Drapeau, Chief Science Officer
Copyright 2009 Stemtech HealthSciences, Inc.


Introduction
While bone marrow adult stem cells have been shown to play an important role in tissue repair, the role of stem cells in tumor formation has also been intensely investigated.
Some scientists have suggested that bone marrow-derived stem cells (BMDSCs) might be involved in the process of tumor formation. The link between chronic inflammation
and cancer has long been recognized, as cancer has been called a “wound that never heals,” and a wound is known to attract stem cells.

It has been proposed that BMDSCs could become tumor cells or enhance the development of existing tumors by contributing to the formation of blood vessels in the tumor. If
circulating stem cells were to contribute to tumor vasculature and tumor growth, then increasing the number of circulating stem cells should accelerate tumor growth.

StemEnhance® is a novel mobilizer of bone marrow adult stem cells that was shown to increase the number of circulating stem. As a result of recent concern, Stemtech
investigated the effect of daily consumption of StemEnhance® on the growth of human breast tumor implanted in a mouse model.

Methods
In brief, fluorescent human MDA-MB-435 cancer cells were grown into tumors, which were later transplanted by surgical implantation into the mammary fat pad of 40
female mice. Twenty-one days after implantation, the mice were randomly separated in two groups. For a duration of six weeks, experimental animals were fed with 300
mg/kg of StemEnhance while controls were fed a placebo. Tumor growth was monitored using live whole body fluorescence imaging. At the end of the study, tumors were
excised and weighed.


Results
There was no evidence of toxicity due to StemEnhance®. Subjects in both groups showed identical body-weight growth patterns and no visual or behavioral differences
could be seen between the two groups.

At the start of the feeding trial, tumor areas for both control and experimental                     	
  
group were statistically identical. Changes in tumor area, and rates of increase                                Ctrl
from weeks one to six, were determined using repeated measures analysis of
variance. Tumor growth was approximately linear, as determined by orthogonal                                    SE
polynomial regression. Tumor growth rate was slower in the StemEnhance®
group (P=0.014) when compared to the control group. The reduction in tumor
growth was significant by week two and at week six tumor areas were 40 percent
larger in the control group (1.70 cm2), when compared to the StemEnhance®                                                                                               Ctrl
group (1.25 cm2) (P<0.01). Metastasis was not seen in either group. At the end
of the study, tumors were carefully excised and weighed. Mean tumor weight in                                                                                          SE
the StemEnhance® treated group (0.44 ± 0.21) was 35 percent smaller than in
the control (0.68 ± 0.42) (P < 0.03). These results for tumor mass are consistent
with the analyses of tumor area.


                                                                                    	
  
                                                                                                                                                                     Figure 3
Discussion
Study subjects received 300 mg/kg of StemEnhance®, which is roughly 10 times the daily intake normally recommended for humans. Even at that high level, growth was
normal and animals showed no signs of toxicity. Daily consumption of the stem cell mobilizer StemEnhance® reduced the rate of human breast cancer growth without
affecting growth pattern. No metastases were observed, at least in the conditions of this study.

Little data exist to suggest how circulating adult stem cells could contribute to reducing tumor growth. It is possible that after migrating in a tumor, attracted by cytokines,
and after proliferating and differentiating in cells of the target tissue, adult stem cells could secrete cytokines inhibiting cellular division.

Other compounds in StemEnhance® could have contributed to the effect observed in this study, such as phycocyanin and specific polysaccharides. Nevertheless, based on
these results, increasing the number of circulating bone marrow adult stem cells does not promote the growth of breast cancer.


Reference
Drapeau, C., Ma, H., Yang, Z., Tang, L., Hoffman, R., & Schaeffer, D. (2009).The Stem

Cell Mobilizer StemEnhance® Does Not Promote Tumor Growth in an Orthotropic Model of Human Breast Cancer. Anticancer Research (29); pgs: 443-448.

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Cancer studysummaryv3 jl27

  • 1. An increase in the number of circulating adult stem cells by StemEnhance® does not promote tumor growth. By Christian Drapeau, Chief Science Officer Copyright 2009 Stemtech HealthSciences, Inc. Introduction While bone marrow adult stem cells have been shown to play an important role in tissue repair, the role of stem cells in tumor formation has also been intensely investigated. Some scientists have suggested that bone marrow-derived stem cells (BMDSCs) might be involved in the process of tumor formation. The link between chronic inflammation and cancer has long been recognized, as cancer has been called a “wound that never heals,” and a wound is known to attract stem cells. It has been proposed that BMDSCs could become tumor cells or enhance the development of existing tumors by contributing to the formation of blood vessels in the tumor. If circulating stem cells were to contribute to tumor vasculature and tumor growth, then increasing the number of circulating stem cells should accelerate tumor growth. StemEnhance® is a novel mobilizer of bone marrow adult stem cells that was shown to increase the number of circulating stem. As a result of recent concern, Stemtech investigated the effect of daily consumption of StemEnhance® on the growth of human breast tumor implanted in a mouse model. Methods In brief, fluorescent human MDA-MB-435 cancer cells were grown into tumors, which were later transplanted by surgical implantation into the mammary fat pad of 40 female mice. Twenty-one days after implantation, the mice were randomly separated in two groups. For a duration of six weeks, experimental animals were fed with 300 mg/kg of StemEnhance while controls were fed a placebo. Tumor growth was monitored using live whole body fluorescence imaging. At the end of the study, tumors were excised and weighed. Results There was no evidence of toxicity due to StemEnhance®. Subjects in both groups showed identical body-weight growth patterns and no visual or behavioral differences could be seen between the two groups. At the start of the feeding trial, tumor areas for both control and experimental   group were statistically identical. Changes in tumor area, and rates of increase Ctrl from weeks one to six, were determined using repeated measures analysis of variance. Tumor growth was approximately linear, as determined by orthogonal SE polynomial regression. Tumor growth rate was slower in the StemEnhance® group (P=0.014) when compared to the control group. The reduction in tumor growth was significant by week two and at week six tumor areas were 40 percent larger in the control group (1.70 cm2), when compared to the StemEnhance® Ctrl group (1.25 cm2) (P<0.01). Metastasis was not seen in either group. At the end of the study, tumors were carefully excised and weighed. Mean tumor weight in SE the StemEnhance® treated group (0.44 ± 0.21) was 35 percent smaller than in the control (0.68 ± 0.42) (P < 0.03). These results for tumor mass are consistent with the analyses of tumor area.   Figure 3
  • 2. Discussion Study subjects received 300 mg/kg of StemEnhance®, which is roughly 10 times the daily intake normally recommended for humans. Even at that high level, growth was normal and animals showed no signs of toxicity. Daily consumption of the stem cell mobilizer StemEnhance® reduced the rate of human breast cancer growth without affecting growth pattern. No metastases were observed, at least in the conditions of this study. Little data exist to suggest how circulating adult stem cells could contribute to reducing tumor growth. It is possible that after migrating in a tumor, attracted by cytokines, and after proliferating and differentiating in cells of the target tissue, adult stem cells could secrete cytokines inhibiting cellular division. Other compounds in StemEnhance® could have contributed to the effect observed in this study, such as phycocyanin and specific polysaccharides. Nevertheless, based on these results, increasing the number of circulating bone marrow adult stem cells does not promote the growth of breast cancer. Reference Drapeau, C., Ma, H., Yang, Z., Tang, L., Hoffman, R., & Schaeffer, D. (2009).The Stem Cell Mobilizer StemEnhance® Does Not Promote Tumor Growth in an Orthotropic Model of Human Breast Cancer. Anticancer Research (29); pgs: 443-448.