Stem Cell Therapy Hype or Hope 

In the medical treatment of the beginning of 21th Century, the word “Stem Cells” certainly became a buzzword, used by many in many different ways creating quite a controversial image of the treatment potential of stem cells.

As you can read on our and many other websites, some, including some regulatory authorities, defend in the name of patients the idea not to use unauthorized new stem cell therapies whereas others advance in treatments and scientific experimentation. How can we find a “consciousness tolerable way” to advance with potential successful improvements of quality of life of patients to support their unmet medical need? Not an easy question because life is precious for those having it, potentially on the way losing it and those believing in protecting it.

To avoid the ethical and moral discussion on when life starts and when embryonic stem cell research destroys life we support only Adult stem cell research and treatments as a part of our “consciousness philosophy”. Anyway, according to new insights of a human body and its cellular functions, in the last few years, we can today use stem cells, from adults avoiding any controversial discussion.

Main places of adult stem cells are bone marrow, adipose tissue (fat), peripheral blood, but also many other so-called Niches in cellular tissues, or from umbilical cord and placenta, contain stem cells useful for therapeutic applications.

When you review websites you will find all kind of therapeutic treatment possibilities, even claiming high success rates. Patients do have to understand that those clinics are talking of anecdotal success rates, i.e. success in individual cases and it is difficult to judge how big the overall success of treatment is.

We believe that with the present reviewing structure of drugs “invented” by companies and eventually approved by health authorities like the FDA / EMA, the market introduction  will take considerable time and even though once approved, there is no guarantee of late side effects as we can see in the annual statistics of adverse events with approved drugs. The only western oriented country which officially changed its regulation to accompany the new technology and its human application are Japan. American and European companies have started to develop their stem cell products in Japan because there is a “fast track” procedure, where a company may bring a stem cell product within a very short period to the market instead of ten plus years in the US and EU countries.

So, there is obviously another reasonable alternative to advance with stem cell treatments besides waiting another decade for approved engineered pharmaceuticals. One is, to try, to enroll in official approved clinical trials in the US or EU;  or to follow the philosophy of Japan where new stem cell treatment products and methods may be available much earlier than in Europe or the US. The other way is to review possibilities in more open-minded countries providing qualified medical tourism facilities or even explore the use of autologous stem cells in a medical procedure, potentially in your home country.

Well, we know, what we are talking about, as we have own experience where “approved mainstream treatment of the meniscus of my wife’s knees” did not go well and as the pain increased further our medical support suggested to go for knee replacement.…..we thought…and thought! Considering that, before the body really has adjusted to the artificial knee you probably will have even increased pain from the surgery and the lesser pain will start kicking in probably only after one year, as friends of us confirmed.

We, therefore, opt to try not to use something artificial but tried a more natural stem cell treatment, so much so more we got informed by our physician that after about 15 to 20 years the artificial knee needs to be replaced. Considering that my wife would be 15 or 20 years older with potentially unchanged or worsened hypertension problems we tried to explore a more natural solution.

Our experience with the Cell Surgical Network (CSN), in February 2015, was changing our life. We are not considering anymore a knee replacement and there is a slow but steady improvement. Most significant one is, that my wife had been able to walk without using “pain medication” for more than 1 year. We are aware that this may not last forever, but before going for a knee replacement we would go back for a stem cell treatment. The pain medication, which had to be regularly changed by the treating physician due to side effects on her stomach, resulting in that she had to take besides pain medication also medication for the associated stomach problem. Our stem cell experience is positive, and we hope that with treatment Know-how, with autologous stem cells, will advance further by using expanded own cells.   

Well,  CSN e.g. has, not only in the US, but also in many other countries affiliated clinics, and we also found now a European clinic participating in the US-based investigational, patient funded stem cell treatments. This treatment is a surgical procedure with IRB approved protocols and FDA and CE resisted equipment followed up internationally with a research coordinator to review the progress of this treatment methods. CSN is using only autologous stem cells harvested from a person’s adipose tissue (fat) via a mini-liposuction, minimal manipulated and return it to the same patient in a procedure lasting less than 4 hours, where most of the time the patient stays in a relaxing lounge. Our understanding is that more than thousands of patients had been treated and followed up with a professional data review system. So far, the treatment method did not result in any reported side effect during and after the treatment, as confirmed by many international reviews on adipose and bone marrow-derived stem cell treatments. We investigated quite extensively those reviews and treatment options on stem cells showing a clear safety profile of stem cells derived from bone marrow and adipose tissues and so embarked to find a solution for our medical need.

As you can see from our website, we are believing that there are technologies which are “helping” the body to improve its natural capability to heal itself. This is alternative and not (yet) mainstream medical treatments, but have shown interesting results in various therapeutic areas like in the case of my wife via a surgical procedure.

These alternatives are basically non-invasive techniques, which can be performed in qualified clinics and even doctors offices either as a surgical procedure and / or as a PEMF – Energy related therapy for health maintenance and wellness.

Stem cell treatment as an essential part of Regenerative Medicine brakes the mold of conventional treatment, becomes a disruptive technology which will, better is already questioning the value with traditional methods of the 20th  century when measured in cost-benefit ratios.  

Traditional treatments which undoubted improved quality of life in the 19th and 20th century is today providing due to advanced technology and Know How, symbolically speaking a proverbial band-aid, whereas stem cells and regenerative medicine helps to support the natural healing capability of a body. Nothing wrong with traditional medicine, but like everything also medical treatment methods have to face  “life cycle changes” and need to adapt to the new science-based technology.

Asian countries are very well in adopting new technologies. This can be observed also now with stem cell treatment methods already being much more advanced than in those countries where regulatory is defending in the name of patient safety, traditional methods, and products. The Electronic Industry is a very good example how the West lost its position, medical science development and more precise its application is presently seeing the same pattern. 

Well, we are in a nearly borderless world, and what companies exercised by moving production to cost-effective places in Asia we see that patients now are doing as well by reviewing cost-effective treatment options.

In this part of the website, you can review with us various potential health and wellness treatment methods. In respect of stem cell treatment and regeneration, we are, however, focusing on treatments as a surgical procedure and PEMF- Energy technologies only.

We are bound by FDA / EMA rules and regulations not to promoting any stem cell treatment or medical device to diagnose, treat or heal, but in the frame of our educational activity we are drawing attention to alternative healthcare methods already used in many countries though considered by some regulatory authorities as unproven and not authorized treatments.

Again, as we are living in a nearly border-less world, we may opt, and use something somewhere where it is potentially an accepted alternative, where patients with physicians freely review, consider and eventually accepting potential risks involved. It is a personal decision, and so far done by those able to finance it, as insurance companies do not cover such treatments, even though the approved treatment ones are often much more expensive in the long run because they treat only symptoms.

Well, there are already treatments offered from Autism to Wound-Healing or very advanced stroke treatments, and although this is very specific cases under research, some countries have developed stem cell treatment capability much further than developed and applied in the US or EU.

Just some few months ago a famous former US Hockey player was hit by a stroke. Gordie Howe’s star power is now raising awareness in the United States and Canada about advances in stem-cell therapies as he continues what is being called a “miraculous” recovery from a massive stroke. He was treated with allogeneic stem cells (not his own / but third party) which are more than minimally manipulated, but legally available in countries outside the US and Europe.

Those governments provide a regulatory frame, where qualified hospitals are permitted to perform those experimental treatments. Gordie Howe went to Mexico because in the US he had, for protocol reasons, to wait 6 months before being admitted to a clinical trial authorized in the US; ………. Family and doctors, however, believed he would not survive the six months waiting period,  and looked for other possibilities to save his life.

The video is controversial in the US and the Stem Cell Company who provided this treatment tries to avoid additional controversy by explaining their view and cooperation with US authorities via clinical trials.

 

Well, Gordie Howe got well quickly and enjoyed life longer than without stem cell treatment because he took the risk. As mentioned before life is personal and decisions are personal decisions independent of viewpoints of regulators. 

We are understanding, patients with unmet medical need looking for alternatives and, we may be able to help in some cases to find qualified places where those activities are performed and connect with other Stem cell advocates to see whether there are patients coming forward to talk about their experience in those clinics. The decision to participate in such investigational treatment is, however, a personal issue after personal risk assessment with your trusted physician. 

We came recently across of an article by associated Professor Leigh G. Turner, PH.D., at the University of Minnesota Center for Bioethics and School of Public Health.  Dr. Turner is mentioning in his article, released on 1. May 2015, that Clinics across the United States are advertising stem cell treatments that attempt to take advantage of what they perceive as exceptions in FDA regulations. According to Dr. Turner, U.S. stem cell clinics often make very persuasive claims about how they are complying with federal regulations. While these assertions might seem compelling, they aren’t necessarily true. On the contrary, his review of federal regulations, warning letters, letters written by the FDA’s Tissue Reference Group in response to questions about how the FDA interprets 21 CFR 1271, and new draft guidance documents, all indicate that the claims many of these businesses make about regulatory compliance are incorrect.

He continues in his review….. “The last five years of relative regulatory inaction is cause for concern. Perhaps these new draft guidance documents are a harbinger of the FDA providing more effective oversight of such businesses. If not, more patients are going to pay thousands or tens of thousands of dollars for so-called adipose-derived ‘stem cell interventions’ even though there is little or no evidence that they are safe and efficacious for amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, spinal cord injuries, and many other diseases and injuries.”

This, from our point of view is a very one-sided review, favoring the clinical trial route for patented pharmaceuticals only, especially when you talk about Bioethics from a global viewpoint, as many countries have already embarked to adjust their regulations to accompany the new science and medical treatment option.

The so-called “inactivity of US regulators” from our point of view is reflecting the “Bioethical discussion” of how to advance with this new science field as many countries have started to adjust their regulations to support those medical advances. Furthermore, Guidelines are “the current thinking” but not binding, again reflecting the ongoing review of how to deal with this new medical advancements.

If we define Bioethics as “the ethics of medical and biological research” we have to accept that the understanding of what is ethical has grown, but it is never complete.  We agree with the definition that Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in biology and medicine…….therefore, it has to be considered as a developing issue. 

As Bioethics is developing like any other science-related activity and confronted with new knowledge, it appears that such a statement reflecting the opinion of Dr. Turner is defending the medical view of the 20th century. This view appears to be outdated when seeing that thousands of patients globally are already very successfully treated with autologous adipose or bone marrow-derived stem cells as a surgical procedure without any reported side effect.

Stem cell treatment is an investigational activity where bioethics apply, but the discussion about bioethics involves in our understanding also patients, their concerns and need, not just only regulators point of view reflecting often a syndrome, we call “not invented here”! The cautious review of US regulators, is not expressing “inactivity” but shows that they are aware of the fast global development in that field, and as their mandate is, to open-minded review and support options and risks in new medical science, they correctly shall not stop or re-regulate applied, investigational medical advances via IRB approved protocols as a surgical procedure.

If you like to get more information about stem cells and potential surgical procedures in patient funded therapeutical studies just follow this link.

 falk.heinrichsohn@live.com

DISCLAIMER
As we are embedded in Western regulations, not allowing the promotion of not approved medicine or medical treatment, we need to draw your attention to our disclaimer, that we are not promoting any unauthorized medicine nor treatments and that any information given in our website had not been reviewed nor approved by FDA / EMA and therefore reflects opinions for educational / informative purpose only.