Stem Cell Enhancers?
This morning I was at the Ethical Society with Flimsy, giving a presentation on the book Evidence of the Afterlife. Our presentation went well, and afterwards I was approached by a nice woman who I have seen occasionally at book clubs and other skeptical events. She told me about this revolutionary new group of products called StemEnhance, StemFLO, and StemSPORT can cure a bunch of diseases and is being produced by a Nobel Prizewinner.
I listened intently, but admitted that I was skeptical of the claims she was making. She handed me a sheet of paper with information and some pamphlets, which I promised to research further.
StemEnhance is purported to be a "natural stem cell enhancer", taking advantage of the media hype over the ability of stem cells to renew themselves and differentiate into different specialized cell types. The company claims that its products (which are marketed for humans and pets) is:
The world's first-ever natural stem cell enhancer… the only nutritional supplement in the world proven to support the natural release of your own adult stem cells from your bone marrow! StemEnhance consists of a patented natural 5:1 concentrate of an edible aquatic botanical known as Aphanizomenon Flos-aquae (AFA for short) that contains two proprietary components, Migratose and Mobilin. AFA grows in a unique, pristine environment in the northwestern United States and it has been safely consumed for over three decades.The whole idea behind taking green algae pills to enhance stem cell circulation is due to speculation by the creators of StemEhance that adult stem cells can repair organs and tissues by "migrating" around the body to various locations. My acquaintance told me excitedly that the makers of this product won the Nobel Prize in 2008 for their work, but unfortunately I think she was given bogus information. The information she gave me read:
"Stem cells are immortal. The problem is detaching from bone marrow and attaching to the damaged organ. The 2008 Nobel Prizewinner irradiated stem cells turning them green and let them repair muscle."
The Nobel Prize in Chemistry for 2008 was awarded to Osamu Shimomura, of the Marine Biological Laboratory and Boston University Medical School, Martin Chalfie of Columbia University, and Roger Y. Tsien of the University of California, San Diego "for the discovery and development of the green fluorescent protein, GFP." The green fluorescent protein was important not because it could "repair muscle" but because it glowed and thus could be used to watch previously invisible biological processes and has aided in stem cell research. The 2008 Nobel Prize in Medicine was awarded to researchers who discovered HIV.
So let's see if this research [1] is as impressive as it sounds, shall we? The research article in question is unfortunately not available to the public, but I took it upon myself to track it down so that I could read it. The study consisted of an in-vitro (test tube) and in-vivo (in the body, with real human subjects) test. In-vivo test consisted of twelve subjects who consumed either StemEnhance or a placebo, had their blood drawn at 30, 60 and 120 minutes after consumption while sitting quietly. The study did not explain how the subjects were blinded, but did describe the placebo pills as looking identical to the StemEnhance pills and being made of dyed potato flakes. The study also did not explain how the researchers were blinded. The researchers tested the blood samples by looking for 6 different markers of stem cells. One of those markers was called CD34⁺.
The results were that "only the analysis of CD34⁺ showed a significant difference upon consumption of StemEnhance… ingestion of StemEnhance resulted in an 18±3% increase in the number of circulating CD34⁺ cells, maximizing at 60 min after ingestion… Questionaired completed by the colunteers on every experimental day revealed that three of the colunteers met criteria for exclusion (e.g., significant lack of sleep, severe anxiety) on at least one experimental say. Exclusion of these volunteers in the analysis resulted in a 25±1% increase in the number of circulating stem cells."
So, their analysis is based on 9 subjects. That is barely enough for a pilot study, especially for substances taken internally. Additionally, the CD34⁺ marker tested for hematopoietic stem cells – cells that can become blood cells but not other types of tissue cells. There is more important information missing from this paper: How were the subjects distributed into placebo and StemEnhance groups? Was the split even, with 6 in the placebo group and 6 in the StemEnhance group? Of the three participants that were excluded, from which groups did they come? This information is essential to research papers. Additionally, the authors say that the difference was significant, but they do not give the actual numbers. They also do not address effect size, which is also essential to research. Giving the effect sizes would allow readers to determine if the differences in these two groups are large enough to detect a real phenomenon. Their P value was set at P<0.05, which is acceptable for preliminary pilot studies. This value is unacceptable for establishing anything beyond that there may be an effect. More rigorous studies are needed to establish if there really is a real effect, and further rigor is needed to establish if that effect is clinically relevant. This product, therefore, is no breakthrough as the pamphlets would suggest.
I am unimpressed by this research. It lacks rigor and transparency found in reputable research. The increase in CD34⁺ is tiny. As another blogger put it:
OK, the extract treatment shows an increase CD34+ cells. A whopping increase from 0.062% to 0.085% (which of course is billed as a 30% increase). Now take a look at the placebo treatment. No increase, just as they claim, but the initial percentage of circulating CD34+ cells is already as high as AFTER StemEnhance treatment. Can anything meaningful be taken from this result? If you continue to read the paper, you'll find that the increase is quite transient, peaking after 60 minutes but lasting no more than 2 hours and that the effect in one person on 16 different test days can vary wildly (from a 300% increase in CD34+ to a 4% decrease).
So this study shows a teeny tiny, but statistically significant increase in circulating stem cells for about an hour after you swallow algae pills. The stem cell circulation then returns to normal. Will this increase in stem cell circulation offer miracle cures? Will consuming fresh clover cure heart disease? There is no evidence of either. Additionally, the researchers in the study (Jenson and Drapeau) are the same people who created and market this product, which means there is a serious, damning conflict of interest.
The chief science officer and brainchild of the company, Christian Drapeau, estimates that the company has sold 425,000 bottles from November 2005 to May 2007 and sells approximately 50,000 bottles per month. At $60 a bottle, that amounts to 25 million dollars of algae pills sold in 2 years and $300,000 in product sales a month. If the product sales have held steady since 2007, that means that they've sold over one hundred million dollars worth of product. That's a pretty substantial conflict of interest. That's over one hundred million dollars worth of product that has not been proven to help people, ever. There is no evidence that this product is safe or that it will improve one's health. In fact, if the product really does what it claims to do, it could "activate dormant cancer cells" according to Kerry Grens at The Scientist. Drapeau is also the former director for R&D at Cell Tech International, another algae company that was sued for making deceptive claims and false advertising. They lost the suit.
Part of StemTech's success at hawking algae pills is their business structure. They operate using a Multi-Level Marketing structure. Multi-Level Marketing, or MLM is similar to a pyramid scheme, and such business models have been subject to criticism and lawsuits. I probably don't need to explain why MLM's are bad news, but if you need more information you can always check out the website MLM watch.
It makes me angry that such a nice lady has been victimized by this company's MLM dubiousness. It bothers me that people can make claims about miracle cures without proving it first. There is no such proof from the makers of this product. My acquaintance was very excited about this product and told me about how there might be some good business opportunities for me if I were to be interested in the product. This is probably not the answer that she wants to hear, though.
[1] Jensen GS, Hart AN, Zaske LA, Drapeau C, Gupta N, Schaeffer DJ, Cruickshank JA. 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 ligand? Cardiovasc Revasc Med 2007:8;189-202
Labels: alternative medicine, science, statistics

