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Stem Cell Scams are Ramping Up? Really?


Google provides my inbox with a literature search on stem cells every day. The title of this article is the title of a recent blog post by an orthopedist[1] who has done clinical research into the use of stem cells as therapy for orthopedic conditions.

This researcher speaks about freeze-dried amniotic fluid derived stem cells, calls them “dead cells” and asks why one would want to treat oneself with something dead, all the while pretending that amniotic fluid-derived stem cells are a valid form of therapy.

This is not an unreasonable question.

On a literature search, we do find documentation of methods of cryopreservation (freeze-drying) which maintain the viability of stem cells treated in this way.[2] One would simply have to determine how the product was treated, and get the evidence of viability for the individual product, before committing to stem cell therapy using that product.

Other researchers speak equally scornfully about any clinics which purport to provide stem cell therapy, lumping them all into the category of “unregulated stem cell industry” or “businesses marketing putative stem cell interventions” and publishing editorials about these treatments in reputable scientific journals.[3]

Physicians are always looking for new ways to help people heal from their dysfunctions and diseases. Ever since the term “stem cell therapy” crossed my horizon, I have thought that, of all the possible options for healing, stem cell therapy has the potential to be the most natural and the most effective, both for healing and for rejuvenation.

Stem cells are, after all, the body’s way of recovering from injury. They provide the body with its template, the perfect example, after which all our cells are designed. And what is ageing but accumulation of injury and oxidative stress over time?

Some of us have flaws in the original template, the one formed when the egg and the sperm first joined together in the fallopian tubes, the very first cell of the embryo’s existence. If the flaw is sufficiently large, we are reabsorbed into our mother’s body, or we are expelled from our mother’s body (we call this a miscarriage). In certain circumstances, the cells in our amniotic fluid, the fluid that bathes the embryo, are examined for defects, through a medical procedure called amniocentesis. If the defects are sufficiently bad, we may be expelled from our mother’s uterus through a medical therapy called therapeutic abortion.

Amniotic fluid is the fluid that bathes the fetus in the womb. Amniotic fluid has been found to contain stem cells.

Of course amniotic fluid stem cells would likely have the same genetic issues – both positive and negative – of both the fetus and the fetus’ parents, so amniotic fluid is not necessarily the perfect tissue.

And amniotic fluid stem cells must be cultured to provide enough cells to actually do a treatment, since those cells are not present in very high concentration in the amniotic fluid itself. It takes about a month to grow sufficient numbers of cells for a stem cell therapy treatment.[4]

Let us accept as proven that amniotic fluid contains stem cells, and that these cells can be grown and cultured to produce larger numbers of potentially therapeutic cells.

Why choose amniotic fluid over our own body’s stem cells?

The real question is three-fold:

  • First, are amniotic stem cells the best source of cells for healing?
  • Second, is the fetus harmed when amniotic fluid is harvested?
  • Third, are amniotic stem cells as good for us as our own stem cells?

As to the first question, are amniotic stem cells as effective for therapeutic use as other forms of stem cells?

One review article[5] describes amniotic fluid as representing “a rich source of stem cells”. However, it is not feasible to remove enough amniotic fluid to provide sufficient cells for even one single stem cell treatment. The article goes on to describe various methods of isolating and culturing these cells. The cells are definitely manipulated outside their normal environment, cultured in various media including serum from fetal cows, before being prepared for storage and use.

Another article[6] also discussed two types of cells found in amniotic fluid, saying that one type, the spindle shaped cells, are more effective than a second type, the round cells, in differentiating into multiple types of cells when cultured.

A third review article published in 2014 describes amniotic fluid derived stem cells as the perfect tool for stem cell therapy – “devoid of carcinoma development and … no ethical debates”.

Amniotic fluid does contain antimicrobial peptides (small protein molecules) active against common bacterial and fungal organisms.[7] There is speculation that amniotic fluid is produced mostly by the fetus, and serves as a reservoir of growth factors, actually playing an active role in fetal development, in addition to its passive role of cushioning against physical trauma.

As to the second question, is the fetus harmed when amniotic fluid is harvested? Amniotic fluid may be collected during the second trimester of pregnancy (approximately weeks 13 through 24).

One review article states: “Amniotic fluid can easily be collected through a safe procedure (amniocentesis) that is routinely performed for the prenatal diagnosis of genetic diseases, its stem cells are not tumorigenic after transplantation, and obtaining amniotic fluid during pregnancy is neither harmful to the mother nor to the fetus.”[8]

However, The Mayo Clinic website outlines some well-defined risks. They include miscarriage (about 0.6%), injury to the fetus by the needle, Rh incompatibility issues if mother and fetus have different Rh blood types, or transmission of infection.

I am not aware of any facilities that perform amniocentesis simply to harvest amniotic fluid for the stem cell content. The fluid can ethically be harvested during abortion procedures, or during diagnostic amniocentesis, or at the time of delivery by caesarian section.

Amniotic fluid is contained deep within the body, in the cavity of the womb. This fluid bathes and cushions the fetus as it grows, serving as a kind of shock absorber for the fetus’ protection against violent movements or blows. It is removed from the body through a needle which is passed through the abdominal wall into the cavity of the uterus. There is no significant danger to the fetus as long as the needle does not accidentally come into contact with it. If the needle penetrates the fetus, then injury certainly occurs – how serious depends on where the needle touches, and how deep it goes into what part of the body of the fetus.

As to the third question, are amniotic stem cells as good therapeutically for us as our own stem cells? That may be at least as much a philosophical debate as it is a physical one.

Using amniotic fluid certainly eliminates the ethical issue of using embryonic tissue for stem cells, because amniotic fluid is not a fetus, nor will it develop into a fetus under any natural circumstances.

Using amniotic fluid would also remove the need to harvest stem cells from bone marrow or adipose tissue, both of which procedures are somewhat invasive.

Our own stem cells are obtained through our own choice – they may be derived from bone marrow or from our adipose tissue or from our blood. We make a conscious decision to have these areas harvested for stem cells, based on our belief that stem cell therapy will help us to regenerate our tissues and lead to improved health and well-being.

In the case of amniotic fluid derived stem cells obtained through abortion, the issue is less clear.

When does life begin? At conception? When the brain forms? When the fetus is potentially viable outside the womb? And when does the fetus begin to experience events beyond the confines of the womb?

One must wonder whether the threat of immanent destruction to the fetus will cause any crisis mode hormone secretion either in the mother or in the fetus – or whether the fetus is simply oblivious to anything that happens outside of its womb environment.

The fetal pituitary gland produces stress hormones by 11 weeks of gestation.[9] And the mother, of course, is capable of producing stress hormones at any time. Crisis mode hormones will logically have some effect on the metabolism of any cells obtained during the crisis.

Emotions affect heart rate variability.[10] It seems logical to conclude that they would affect the fetus as well as the mother.

In the case of therapeutic amniocentesis, the procedure is performed because there is suspicion of genetic abnormality – which in itself raises questions about the health of the amniotic fluid cell population.

In addition, there is always the concern of the health of the donor of the amniotic fluid.

The FDA issued guidance in March of 2016 for donor screening to reduce the risk of transmission of the Zika virus. This would seem to imply that there actually is a risk of transmission of this virus (among others) through amniotic fluid. Blood specimens from 3% of asymptomatic blood donors in French Polynesia were positive for the Zika virus.[11]

Any genetic abnormality of the donor will be transmitted through the donor’s stem cells. And we have no way of screening for all possible abnormalities or infections.

Older individuals produce older stem cells, of course. The health of the stem cell will be to a certain extent dependent on the health of the body from which it is derived. On the other hand, stem cells do not divide nearly as frequently as regular body cells, and therefore have not lost as much of their youthful telomeres as regular cells. Thus “old” stem cells may not be nearly as “old” physiologically as we might think.

Amniotic fluid stem cells, on the other hand, are very young, and therefore in theory healthier and more capable of rejuvenation than older cells. Nevertheless, they are foreign to our own bodies, may have unknown genetic changes, and may even incorporate infections not present in our own body’s cells.

I personally would vote for using my own cells to heal my own body. At the Arizona Center for Advanced Medicine we do not use amniotic fluid as a source of cultured stem cells for our therapies. We use our patients’ own body tissues if they choose to do any form of stem cell therapy.

Anyone who decides to do the stem cell therapy procedure will need to make a decision as to the source of the cells based on their own reflection and research.

For more information, please call us at 480-240-2600 to set up a free 15-minute phone consultation, to determine whether stem cell therapy may be a good option for you.

[1] Chris Centeno, M.D. is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.

[4] Pieternella S. in `t Anker, Sicco A. Scherjon, Carin Kleijburg-van der Keur, Willy A. Noort, Frans H. J. Claas, Roelof Willemze, Willem E. Fibbe, Humphrey H. H.Kanhai. Amniotic fluid as a novel source of mesenchymal stem cells for therapeutic transplantation. Blood 2003 102:1548-1549; doi:10.1182/blood-2003-04-1291.

[5] Gholizadeh-Ghalehaziz S, Farahzadi R, Fathi E, Pashaias M. A Mini Overview of Isolation, Characterization and Application of Amniotic Fluid Stem cells. International Journal of Stem Cells 2015;8:115-120

[6] Roubelakis MG, Bitsika V, Anagnou NP et al. In vitro and in vivo properties of distinct populations of amniotic fluid mesenchymal progenitor cells. J Cell Mol Med 15;9:1896-1913 (2011).

[7] Tong XL, Wang L, Xu YP et al.Potential Function of Amniotic Fluid in Fetal Development —Novel Insights by Comparing the Composition of Human Amniotic Fluid with Umbilical Cord and Maternal Serum at Mid and Late Gestation. J Chinese Med Assn 72;7:368-373 (July 2009).

[8] Baghaban Eslaminejad MR, Jahangir Sh. Amniotic fluid stem cells and their application in cell-based tissue regeneration. Int J Fertil Steril. 2012; 6(3): 147-156.

[9] Mastorakos G, Ilias I. Maternal and fetal hypothalamic-pituitary-adrenal axes during pregnancy and postpartum. Ann N Y Acad Sci. 2003 Nov;997:136-49.

[10] Rainville P, Bechara A, Naqvi N, Damasio AR. Basic emotions are associated with distinct patterns of cardiorespiratory activity. Int J Psychophysiol 61;1:5-18 (July 2006).

[11] Musso, D, Nhan, T, Robin, E, Roche, C, Bierlaire, D, Zisou, K, Shan Yan, A, CaoLormeau, VM, and Broult, J, Potential for Zika virus transmission through blood transfusion demonstrated during an outbreak in French Polynesia, November 2013 to February 2014. Euro Surveill, 2014. 19(14).