Medicine in times of change!

The history of medicine is filled with stories of strange tonics, outlandish remedies and “curious cures”.  Medical treatment in the 19st and 20th Century has advanced substantially with the discovery of antibiotics, and numerous chemicals and biological’s to treat illnesses.

When we talk about, treating illness, we have to review also the time line of human anatomy. Already Michelangelo (1475 -1564) humananatomy 2 was very interested in the human body, especially the male body. To be able to really understand human anatomy, he wanted to make studies of corpses. This was strictly forbidden by the church and to be able to make these studies he bribed the prior of the church of Santo Spirito by giving him a wooden Crucifix, made by Michelangelo himself.

Because of him studying anatomy so closely he was able to depict the human body in such an incredible way, both in his painting and sculptures.

From the time of Michelangelo to modern science, there had been many different approaches made to understand the anatomy of a human body and to treat illnesses. The present mainstream thinking in medicine to treat illnesses is with chemicals and biological´s, developed mainly in the last two Centuries. Although there had been made enormous progress especially in the last twenty years in treating illness, we are, however, still mainly treating symptoms.

Like everything, Know How also in medicine is evolving further and each time faster, and what is today’s mainstream maybe will be already soon tomorrow’s historic procedure. With advances in science, where electronic assisted technologies doubles its technological advances in less than two years at this moment, we have been able to go deep down on a molecular, cellular level, and each time more we have to realize that our human body is a complex system of cells, having a natural capability of healing itself.

Modern medical research has indicated that “Humans are a biological  systems, embedded  in  an  electromagnetic energy field, communicating with  its  specific  neural  network, a network being able to  exchange and  analyse  information  with incredible speed and  with this, initiating needed actions based on electrical impulses triggering biological and chemical related reaction at its cellular basis. This biological and chemical related actions can be enhanced by stimulating the body’s own defence system via experimental stem cell and genetic treatment as well as electromagnetic field technology.” 

We are not really aware of our body’s natural behaviour, but with each heartbeat, we are sending electromagnetic signals into our body to initiate functions on a cellular level to maintain health or correct injuries.

On average each of us replaces,  i.e. regenerates  about 1.7 Million Cells per minute, and  about 1.0 Billion Cells per hour from the about 100 plus trillion estimated cells any human has. We POSSIBLY age as a result of inability to regenerate over time all so far fully functioning cells and the capability to fully repair our tissues!

Let’s face it, our body is at war against infection, disease, aging, and sometimes itself every second in our life. Our immune system is the first line of defence. Anything that it can’t deal with will do some damage. Our Stem Cells are the natural “crews that repair this damage”.

If a body´s condition or disease has become chronic, this means that the “damage & repair crews” cannot handle the job, they need help. In the last century we used pharmaceuticals and some dramatic surgery mainly. In the 21st Century we have found that stem cells can be supportive and become a vital part of the “damage & repair troops” to help in the regeneration (repair) process of an individual and his disease status.

Stem cells can be stimulated with their powerful “homing” mechanisms which enable them to home in on areas of the body that are in need of repair. Autologous cells can be taken from an individual and then put back into the same individual at the same day medical practice procedure and improve this first line of defence considerably. PEMF systems as shown in anecdotal studies may even increase further those healing activity of stem cells.

Based on this new knowledge, we also could imaging that our mind could be able to influence these signals and functions too. There are many reported cases where it has been proven that our mind strongly influenced the outcome of a treatment when ill. In medical terms this is often just simply defined as “Placebo Effect”

A video, I recently found regarding the placebo effect is quite interesting, confirming the incredible capability of our mind, and I like to share it with you:

 

Already in the beginning of the 20 century various scientist verified and experimented with electromagnetic waves to heal illnesses.  As our mind, with its thoughts, is transmitting also electromagnetic impulses it is assumed that the placebo effect is strongly related to the influence of the mind on our cells and within on our body. The video above shows some remarkable recovery stories using a kind of Placebo therapy.

We know, when electromagnetic activity ceases, life ceases. Electromagnetic energy controls the chemical reactions in our body, any disruption of this energy in cells causes weakened cell metabolism, and if our cells are not healthy, our body is not healthy.

Modern medical treatment is each time more confronted with the philosophy of a more holistic approach moving away from toxic, invasive and often not effective treatments.

Clinics and physicians working with this new treatment models are trying to stimulating the body’s own cell capability to renew and repair the injured body in a truly natural way. Stem cell treatment and manipulation of stem cells is a new medical concept and fast growing area of new medical know how and has in some countries already passed its experimental status.

While reviewing the development of medicine throughout the time we believe that, with the arrival of the 21 century, it’s fast advancing technological Know How, there will be fundamental changes in the way as we are treating illness.

The two main pillars we see in medical treatments are:

1.  Traditional Medical Treatment developed in the last two centuries.
In the field of traditional treatment, we see mainstream medical doctors prescribing pharmaceuticals developed by industry and approved by FDA / EMA as new Chemical respectively Biological drugs and Vaccines or alternative treatments outside the FDA Approval, like Acupuncture, Homoeopathic treatments, Magnetism, and non-prescription drugs as OTC’s or wellness and age related non pharmaceutical regulated treatments.

2. 21st Century, Technology Driven experimental Treatments
Stem Cells and Gene manipulated cell developments which may interfere on cellular level will change medical treatment in the 21st Century. Technology like 3D printing and / or PEMF Therapies will become a supporting element of stem cells treatment and a game changer in the new treatments where allogeneic versus autologous methods and philosophies will compete in a way never seen before.

It will be the first time, that drug development by the industry with its philosophy “one medication in a bottle fits all” will meet a valid alternative treatment method in form of fully personalized treatment as a same day surgical procedure by a physician using stem cells and tissues of the same individual in a same day surgical treatment method.

In this first phase, autologous stem cell treatment is launched in many counties in the frame of the “minimal manipulated” regulations by FDA / EMA but in time and with further experience those personalized treatment will use also expanded own stem cells to enhance the treatment result. Outside the FDA / EMA regulated countries this treatment method became already reality.

Patients, as anecdotal studies shows, are potentially be better off when using autologous (own) stem cells and tissues, showing so far no or very little side effects, compared to treatment with traditional drugs and biological’s or allergenic stem cells and tissues.

Western regulators like the FDA and EMA unfortunately are regulating allogeneic and autologous stem cells and tissues in the same way like chemical and biological drugs causing much delay in potential early successful autologous stem cell treatments, while Eastern countries are adjusting their regulations in order to accompany the new medical reality better.

It is understandable that allogeneic stem cells and gene therapies are causing risks and safety concerns when it comes to treatment in humans. This safety concerns are however not justified when it comes to treatments with own especially non-expanded stem cells and tissues. Those, by regulators, expressed safety concerns are not justified, as no serious side effects had been reported so far by the thousands of surgeries in the cosmetic field as well as experimental treatments by medical professionals in same day surgical procedures using SVF from adipose tissues for various experimental treatments all over the globe!

In a recent discussion about the FDA’s new draft regarding stem cell regulations in the LinkedIn’s “Cell Therapy Industry group”, the group talks about the so-called ground breaking draft guidance statement by the FDA, where the FDA for the first time according to Dr. Paul Knoepfler sends the message to the clinics that those clinics treating patients with experimental stem cell treatments are very likely wrong and could be subject to future regulatory action.

Of course, some researchers and physicians involved in developing patentable products welcome such a regulation, but is this really the best regulation for patients?

There are always pros and cons in regulations but as mentioned before there are two ways to treat patients in future.

1.  The first way is the traditional way with FDA / EMA approved drugs prescribed by physicians and

2.  the new second way where physicians in a same day surgical procedure treat a patients with his own cells and tissues to improve its natural healing process.

In connection with the same day surgical procedure, I would like to draw attention to an important observation by Luis Martinez of Regenerative Medicine and Cell Therapy and  a member of the Cell Therapy Industry Group in the LinkedIn discussion panel:

 “….. the FDA draft makes various erroneous assumptions. I’ll name one which I believe technically disqualifies the whole argument to regulate adipose tissue as a drug. This relates to how FDA defines Adipose Tissue. I am copying the definition as it appears in the draft and taken from Dr. Paul Knoepfler’s blog:

…….Example 10-1: Original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity……..

This definition completely fails to mention the fact, that the Adipose tissue is a metabolically active, hormone and cytokine secreting tissue. Therefore, adipose tissue’s role is much more than just structural and storage. Adipose tissue is involved in neuroendocrine regulation as well as cardio metabolic and inflammatory response regulation. As such, using ADMSCs Intravascular or in other tissues or compartments would be in line with homologous use, as regular adipose tissue is normally involved in many of these secretory functions.”

It is a surprise to see how “the draft definition of adipose tissue changes the scientific proven role of adipose tissues by limiting its function to just only structural and storage related”.  Guidelines should be defined by independent professionals to support unmet medical need and not to fit into industry defined standards.

Pharmaceutical drugs and vaccine development advanced undoubted considerably to treat illness in the 19th and 20th Century. Blockbuster Drugs, developed by the pharmaceutical industry improved quality of life of patients considerably, though negative side effects sometimes do caution the use of chemical and biological drugs to treat symptoms of certain illnesses.

Surgery and diagnostic of illnesses aided by high tech equipment have helped to improve effectiveness and recovery time considerably, like e.g. laparoscopy technology. Science and technological Know How, advances extremely fast and science related Know How are doubling in many fields at a rate of less than two years. There is nearly not one week in this early 21st Century that we do not hear of a new breakthrough in medicine related to cellular, genetic, stem cell science and electronic equipment and science.

Regenerative medicine, although still in an experimental phase is able to support the manipulation of cells, genes, produce skin, bladders, windpipes and full functioning organs amongst many other treatment possibilities. As mentioned earlier we are “approaching curing” in medicine right in the beginning of the 21st Century, with either expanded and more than minimal manipulated stem cells and gene manipulation or with same day surgical procedure with own adipose or bone marrow derived stem cells. This same day surgical procedure is a viable alternative to the unsustainable cost structure of existing healthcare systems.  Regulations which are denying physicians and patients the right to follow the philosophy of practice of medicine are considered by patients and practitioners inhuman. Many countries have given patients a choice of treatment, by allowing experimental alternative / stem cell treatments in case a patient is signing a consent letter, stating that he understood the risk of the alternative and experimental treatment method.

The intentions of FDA to regulate autologous stem cell treatment each time more stringent confirms the scientific already proven therapeutic value of own stem cells. In our view any regulations on own stem cells and its personalized use interferes with the constitutional right and freedom of individuals to choose with a responsible practitioner experimental treatment in the frame of practice of medicine as well as the Protocol of Helsinki.

The mandate of health regulators is to safeguard patients in respect of commercially available, manufactured drugs and its potential side effects in human beings and avoid, respectively reduce potential of communal diseases transmitted via medical treatments with drugs, tissues and cells.

The medical treatment with own (autologous) stem cells and tissues as a natural source of increasing the capacity of the same bodies defence system with his own biological material as a truly personalized treatment and therefore has nothing to do with manufacturing a product at a specific place being sold at a complex supply chain to be eventually used, injected by a physician into a human body, not fully understanding or knowing how his / her immune system will react to the third party derived medication.

Legislators in some countries have already recognized the difference of the two treatment methods using either allogeneic drug related manufactured products for treating many patients or the same day surgical treatment with autologous stem cell and tissues and by such trying to avoid to regulate artificially two competing technologies with the same basic set of regulations.

As long as regulators do not accept the two different stem cell treatment methods and their scientific and medical different approaches, we will see an increase of medical tourism to those clinics offering even expensive unethical snake oil treatment for patients, not able to satisfy their medical needs in their over-regulated home countries.

There are many qualified clinics with high technological standards available in Latin America or Asia, offering experimental stem cell treatment and a good follow up of their patient funded studies. Presently, also  various clinics in the US and Canada offer this safe surgical, same day medical treatment, but the new FDA regulations are threatening that those so far medical activities may become a drug regulated activity, and with this will not be allowed to be performed in FDA regulated countries.

We are asking our readers and patients to involve and comment against those new FDA regulations, published as draft for comments by industry and public, obviously reducing further the medical treatment choice of patients and their physicians favouring only industry developed and manufactured drugs, due to overstated patient safety issues.

We believe both methods and products (allogeneic versus autologous stem cells and tissues) will be beneficial to patients and their treatment of present unmet medical need, but the choice should not be government regulated but freely decided between the patient and his trusted physician.

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