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Being cautious about stem cell treatments

The term “stem cell” has become a buzzword, a phenomenon, a presumed future treatment for everything from toe to head, from injuries, over cancer to Alzheimer’s. A huge industry has grown up around this term, with hundreds of so-called stem cell clinics offering treatments alleged to involve the use of stem cells. According to a recent article in The Washington Post by Laurie McGinley and William Wan, as recently as in 2009, there were only two such clinics in the U.S.; now there are over 700, and over 150 have been opening every year.

Yet, as the article also noted, what is injected into human beings by many of these clinics often are not stem cells and, even if stem cells are used, most of the offered treatments in these clinics are more quackery than medicine. The Food and Drug Administration (FDA) announced a clamp down on potentially “dangerous” treatments in these clinics but critics are very vocal that steps taken so-far have been insufficient.

Though everybody seems to be talking about stem cells, most people actually do not even understand the term. Here is, therefore, a little basic background information that should help in understanding “the con” many of these stem cell clinics are perpetrating on the public. Let’s start with the explanation what a stem cell is: Stem cells are part of the body’s highly sophisticated repair system. They can divide indefinitely, producing new cells, and can be multipotent or pluripotent. Multipotent stem cells can give rise to only a small number of different cell types, while pluripotent stem cells (PSCs) can give rise to practically all cell types in the body, with only very few exceptions. As they divide, they can become again a stem cells or they may pursue another fate and evolve into another cell type with a special function.

In some organs (pancreas and heart and, possibly, the ovary, though that has in the human remained a highly controversial issue), stem cells may be inactive for long periods of time, part of a human tissue without dividing, while in other tissues (gut and bone marrow) they divide constantly, thereby repairing tissue defects. Stem cells in most organs/tissues, therefore, are multipotent, while so-called embryonic stem cells, derived from the inner cell mass of a preimplantation-stage embryo, are pluripotent. Because embryonic stem cells are pluripotent, they became the favored subjects of research and, indeed, till today are still considered the best stem cells to work with.

But it quickly became apparent that non-embryonic stem cells were present in different organs and tissues at all ages, and those are now called somatic or adult stem cells. Because they did not offer the flexibility of embryonic stem cells, most researchers initially were not big fans of these cells. But in 2006 researchers (who ended up winning the Nobel Prize) figured out a way how already quite specialized adult stem cells could be genetically reprogrammed to “regress” into a pluripotent stem cell-like state, called induced pluripotent stem cells (iPSCs), and these iPSCs are now in serious research centers subject to extensive research and beginning clinical applications.

iPSCs are ideally suited for clinical use because they can be “produced” from a patient’s own adult stem cells. Their reintroduction into the patient, therefore, will not cause an immunological rejection response. iPSCs are, however, not what most so-called stem cell clinics utilize in their treatments. What they inject into patients are often insufficiently purified cell fractions contaminated with other cell populations. Especially popular are fat tissue-derived stem cells because fat-cells can be extracted in great quantities with relative ease from most patients. When at one clinic so-called “stem cells” were injected into the eyes of a woman with macular degeneration, the treatment resulted in retinal detachments and subsequent blindness, as, likely, fibroblasts were part of the cell mixture injected. McGinley and Wan correctly reported in their article in The Washington Post that fibroblasts, however, induce fibrosis and scarring, and scarring in the eyes leads to blindness. This case and other similar horror stories attracted considerable attention in the media and resulted in the FDA’s announcement that the agency would clamp down on “dangerous treatments.” But what represents such dangerous treatments has mostly remained undefined.

When stem cell treatments are advertised (and many of those stem cell clinics are not bashful in their claims), caution is, therefore, indicated: What credentials does the clinic and its physicians have? Have they published any of their results in a peer reviewed medical journal?

One conclusion is almost always correct: Medical claims that have not been published in a peer-reviewed medical journal, especially if they sound too good to be true, will, more often than not, be bogus. Even medical journals cannot be trusted anymore as in the past because electronic medical publishing has led to an unbelievable inflation in the number of medical journals, claiming to be “peer-reviewed, when in reality they will publish anybody and anything, as long as they are paid publication fees. Even publications, therefore, now have to be viewed with caution and, unless a journal is reputable in its specialty area, claims made should be treated with suspicion. After all, the more important a clinical breakthrough, the more likely will a reputable journal want to publish the study and, of course, vice versa. Above noted not-really-medical journals in combination with the “fake-science” propagated by some of these stem cell clinics, can, thus, create a very dangerous world of “fake-medicine,” highly confusing to public and even media.

Stem cell treatments in infertility started with the rather audacious AUGMENTSM treatment, widely propagated by a company named Ovascience. The company’s treatment was based on the claim that that injections of mitochondria, obtained from the patients’ own alleged ovarian stem cells (from an ovarian biopsy the patient had to undergo by laparoscopy) would “rejuvenate” (older) patients’ eggs if injected into their cytoplasm. CHR at the time repeatedly questioned the utility of this procedure in these pages and warned about its utilization.

That the whole concept, indeed, never made much sense, did not deter the company; neither was the company deterred when the FDA prohibited the procedure in the U.S. But, most surprisingly, least deterred was Wall Street, which at one point valued the company at $1.8 billion (and, yes, that is billion!!). By December 2016 the company’s market value had, however, fallen to a mere $47 million, though some people obviously had made a fortune on selling snake oil on the way to patients, referring physicians and Wall Street investors.

More recently, stem cell treatments have been proposed in reproductive medicine in principle for two conditions: The first is endometrial rejuvenation through injection of mostly bone marrow-derived stem cells in women with Asherman’s syndrome (scarring of the endometrial cavity), initially suggested based on animal studies by colleagues at Yale University in New Heaven, CT, and later studied in a small clinical trial by Spanish colleagues. Both groups are highly credible, though premature commercialization, especially of the Spanish efforts, are again somewhat concerning.

Even more of concern are announcements of injection of “stem cells” into ovaries, as these announcements come from a commercial outfit that has been closely associated with questionable stem cell practices in a number of clinics in other medical specialties. The proposed purpose of these injections is rejuvenation of ovarian function, though, as of this point, is not clear whether that means reactivation of ovaries from women with premature ovarian failure (POF)/primary ovarian insufficiency (POI) or treatment of women with only premature ovarian aging (POA)/occult primary ovarian insufficiency.

The difference between those two is, of course of great importance since, especially here at CHR, women with POA/oPOI have usually still excellent outcome chances with much more proven treatment approaches; yet, women with POF/POI, indeed, generally have only egg donation as their option to, still, become a mother.

A registered clinical trial is, allegedly, in preparation at or in association with a well-known Midwestern medical school. One can only hope that the Institutional Review Board of that institution closely supervises this trial and does not permit undue marketing for commercial gains before efficacy of such treatment has been established.

There can be little doubt that stem cell therapies will in the future greatly contribute to medical care, maybe even revolutionize health care. Yet, nothing is more harmful than premature use of promising new medical treatments outside of investigational frameworks. The danger in such cases is twofold: Incompetent planned and executed investigations practically never yield usable results that allow determination of efficacy of a treatment. The even bigger danger, however, is that absence of an affirmative result may be viewed by the public as a negative result, giving the wrong impression that a potentially effective treatment is worthless. That stem cell studies in infertility practice, therefore, be conducted appropriately before these treatments are introduced into routine clinical practice, is, therefore, of crucial importance.

This is a part of the May 2018 CHR VOICE.

Norbert Gleicher, MD

Norbert Gleicher, MD, FACOG, FACS

Norbert Gleicher, MD, leads CHR’s clinical and research efforts as Medical Director and Chief Scientist. A world-renowned specialist in reproductive endocrinology, Dr. Gleicher has published hundreds of peer-reviewed papers and lectured globally while keeping an active clinical career focused on ovarian aging, immunological issues and other difficult cases of infertility.

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