No Threat of Cancer from Using Autologous SC to Treat Ortho Conditions

[Claire]

By Dr. C. Centeno

Is there a stem cell treatment cancer risk? Because of the press surrounding embryonic stem cells and misinformation spread by many in the stem cell research community, some patients still have a fear of potential cancer risks with an adult stem cell procedure. This fear extends to even the same day procedures, where it would be difficult to scientifically concoct a circumstance where cancer would be a concern. Now a new study, along with the safety data our group has already published, should put those fears to rest.

The concept that stem cells could cause cancer comes from embryonic stem cell (ESC) research. Because stem cells taken from a growing embryo are tasked with building a person, they can sometimes still try to build a person when used to treat a disease. The resulting mishmash of tissue is called a “teratoma”, a benign tumor that has many different types of tissue such as hair, teeth, muscle, bone, etc… Despite this weird fact, adult stem cells are a different animal altogether. They are not taken from a growing embryo, but instead from an adult. While ESCs do have a teratoma risk, no adult stem cell cancer risks have ever been published in human studies. In fact, getting adult stem cells to create a tumor in animals is tough. To make that happen, you usually have to add in things like “tumor conditioning media”, grow them for insanely long periods, and then put them into animals that have been bred to have no immune system!

We’ve published a bunch of data, both online and in scientific publications showing no increased cancer risk when using both same day and cultured stem cells to treat orthopedic problems. For example, our registry experience with more than 1,100 patients treated with same day stem cells showed no such risks. In addition, our data published in scientific journals on cultured stem cells also showed no increased cancer risks, even when patients were followed for many years. In fact, we voluntarily gave our source data to an independent European research group upon request and they concluded that our cultured stem cell procedure was safer than FDA approved knee gel injections.

Now a group of European scientists has published yet another long-term safety study, this time in the area of same day stem cell procedures used to treat orthopedic problems. A total of 1873 patients were treated from 1990 to 2006 with bone marrow-derived concentrated stem cells. Patients were monitored for cancer incidence from the date of the first operation (1990) until death, or until December 31, 2011. The mean follow-up time was 12.5 years (range, five to twenty-two years). The primary outcome was to evaluate the risk of tumors at the stem cell therapy treatment sites. The secondary outcome was to evaluate the risk of cancer diagnosed in areas other than the treatment sites. No tumor formation was found at the treatment sites on the 7306 MRIs and 52,430 x-rays obtained on the 1873 patients. Fifty-three cancers were diagnosed in areas other than the treatment site. On the basis of cancer incidence in the general population during the same period, the expected number of cancers would be between 97 and 108 for the same age and sex distribution (this group saw about half that many in treated patients). The conclusion? The study found no increased cancer risk over an average follow-up period of 12.5 years.

The upshot? This most recent study, as well as others, FDA clinical trials data, and the data we have published now amounts to about 10,000 patients who have been treated with adult stem cells and extensively tracked for this issue. There is no evidence that adult stem cells cause cancer. There is no rational reason for the fear, other than a completely different type of cell (ESC) that happens to have a similar name (stem cell) can cause teratomas – hence the confusion!

 

[barbara]

The naysayers toss the C word around constantly in an effort to support their argument that even autologous stem cell therapy is "risky". Those like blogger, Paul Knoepfler and others in the research community, will continue to ignore the evidence that Dr. Centeno and others provide. Having had many treatments, I should be riddled with cancer by now if the naysayers are to be believed. They will continue to spread these unfounded, "unproven" (a word they love to use), warnings because they have their own interests to protect. Patients treated successfully with their own stem cells as a medical procedure are a huge threat to academia, politicians, FDA, media, Big Pharma, charitable organizations, and many more.

 

[Claire]

You have to admit that, when even Bernie Seigal (spelling?) of the ISSCR can't win an argument with me on LinkedIn RE: the superiority of ESCs vs. Auto SCs, "ESC Inc." is seriously in fear for its life and grant monies! Now Dr. Centeno takes away the last, big scare tactic ESC Inc. had left in its repertoire: CANCER. I'm just waiting for the Fat Lady to sing loudly enough via Right To Try legislation and relegate ESCs to the "For Research Purposes Only" status for the foreseeable future.

It's over, for the foreseeable future, and ESC Inc. knows it!

 

[barbara]

What bothers me is that the certain group of researchers who have decided they know what's best for us have failed to acknowledge published data from Dr. Centeno and others. How can we believe that these researchers are credible if they themselves are not forthcoming in their support of these studies? It doesn't pass the smell test to me and only increases my suspicion that they are protecting their own interests rather than good science.

 

[Claire]

Agreed!

The FDA is denying patients the right to use our own SCs without submitting to FDA drug approval, as opposed to being classified as “medical procedures,” regulated by state medical boards, hospital privileges, public health departments, and the Torts system. Why? Because allowing us to use our own SCs as a Practice of Medicine would "depress the market for competitors:" the main competitors are the pharmaceutical companies. Moreover, many researchers have invested their entire careers in ESC or iPS research and they will fight to the death to suppress the use of auto SCs and keep the grant monies flowing to ESCs, iPS cells and other "designer cells."

There is no justification for holding what should be a practice of medicine to the standards of the mass manufacture of pharmaceuticals. Bringing a new drug to market costs billions and takes decades. Even if a doctor could hypothetically do that for each patient, would the patient still be alive if/when the personalized “drug” is approved? There is no public health threat that merits the FDA's regulatory overreach into the practice of medicine.

Only I will receive my stem cells; they will not be distributed to the masses. So, how can one justify holding a physician to the same standards as a mass manufacturer of pharmaceuticals? Many hospitals would fail such an inspection. Blood transfusions and the highly manipulated material, often involving multiple parties, for In Vitro Fertilization is not held to the standards of a mass manufacturer of drugs. The FDA made up distinctions regarding the amount of cell manipulation out of thin air; it created a new “minimally manipulated” threshold, which gives it authority over a medical procedure. “This is a crime against ill people who can’t afford to travel overseas for treatment. America should be fast tracking this treatment, not slowing the adoption process to the crawl involved in drug approval. The FDA requirements, designed for products manufactured and sold on a mass scale, can’t be readily satisfied when it comes to treatments that are personalized to individual patients.” This is a personalized medical procedure, not a drug.

Auto SCs are the safest, most effective option for many patients, suffering from a variety of conditions, but our SCs can't be patented unless they are reformulated into outrageously expensive pharmaceuticals. So, we are condemned to suffer and die an "FDA approved death." The FDA can't manage to execute its pre-existing mandates; now it extends its corrupt, inefficacious tentacles into the practice of medicine? And it presumes to extend its jurisdiction worldwide?

ESCs have been researched for close to two decades, arguably since the 1960's when Till and McCulloch discovered ESCs. It is 2014. ESCs have yet to be proven safe for use in humans; they have produced no significant, real world results for patients. ESCs are highly tumorigenic.

The use of auto SCs is a paradigm shift in medicine, which is analogous to Dr. Jenner’s observations that lead to the Smallpox vaccine and Dr. Flemming’s discovery of Penicillin. “Other than vaccines, nothing in all of medical science even comes close in profundity to the human condition except for the hugely important medical notion called the ‘Germ Theory,’ which ultimately led to public sanitation, medical sterilization, vaccines and then to antibiotics.” The use of auto SCs is the medical breakthrough of our times. The status quo has too much invested in the prevention of said breakthroughs.

Our SCs can't be patented unless they are reformulated into outrageously expensive pharmaceuticals. So, we are condemned to suffer and die an "FDA approved death," or be forced off-shore at great cost and physical pain. This is a death sentence to those who are too impoverished or too disabled to go off-shore.

My current FDA approved options are to submit to invasive, risky, potentially deadly, traditional back and knee surgeries, which typically result in the need for additional surgeries within three to ten years, and narcotic drug dependencies (or take NSAIDS that TRIPLE my risk of a serious cardiovascular event) or be forced off-shore at great cost and physical pain to use my own stem cells. Three of my physicians, including one educated at Oxford, fully support my choice of treatment and my doctor of choice, in lieu of traditional back and knee surgeries at my age.

Recent research reveals that fake knee surgery is just as efficacious as traditional knee surgery: not very efficacious. Similarly, the human spine is meant to be flexible. Fusion leads to additional problems in other areas of the spine. Nor does the idea of having a narcotic pain pump installed in my back appeal to me. It is noteworthy that almost everyone has back and/or knee problems by the time one is in one’s forties; this is not an insignificant population in the medical community.

I have been a disabled "shut in" for over two years now; this has been emotionally and financially devastating to my family and me. Auto SCs have been proven safe repeatedly and have produced significant, real world results for thousands of patients. I ask the self-appointed critics: How would you feel about this issue if I were your daughter, your wife, your mother? Keep telling me to wait? Become a narcotics junkie? Undergo dangerous, "nuts and bolts,” inefficacious surgeries?

Regulating auto SCs in the same manner as mass-produced pharmaceuticals places undue burdens on physicians and stifles medical innovation. Allowing patients to use auto SCs will revolutionize the practice of medicine in this country. Our own cells provide doctors with the potential to cure or ameliorate many chronic diseases, illnesses and injuries in a safer, less invasive and more cost effective manner. The potential overall health care savings are enormous and the societal benefits incalculable. Imagine disabled people returning to the workforce; imagine fatal disorders becoming temporary problems. Imagine debilitating, chronic pain becoming a warning that something needs to be fixed, rather than a life sentence.