Regulations………

Regulators, Legislators Taking Action on Unproven Stem Cell “Treatments”

December 2017 by ISSCR – International Society for Stem Cell Research

Below there is a published statement by ISSCR explaining the legal viewpoint of stem cell treatments, which we as patient advocates believe is a very much one-sided viewpoint favoring the clinical trial path ONLY. Considering this part of FDA regulation, developing a drug for the mass market, it is correct, those stem cell treatments are not FDA approved, but we are not talking about a drug treatment we talk about a medical procedure for individual medical cases being outside the regulated mass-produced drug market.

To bring new medical treatments & products to the market and help patients with unmet medical needs, we have two pathways. Industrialized produced products for the mass market versus individualized treatments as a medical procedure in a Point of Care setting. Both paths have been successfully developed and introduced products and technology to the market.

The well-established, but much slower drug/pharmaceutical pathway did benefit primarily in the late 19th and early 20th century millions of peoples with the discovery of vaccines, immunosuppressants, NSAID´s, statins to mention a few.

The physician’s pathway already existed in early time, well demonstrated with Hippocrates, around 300 BC, considered the father of medicine. This path especially in the 20th century, paved the way to open heart surgery and IVF, opening up entirely new avenues of medical treatments, which continues on an accelerated path in this early 21st century with cellular and stem cell treatments.

Both pathways have their place in the medical treatment field, while one, the drug-related, is developing therapies in the slow and robust aircraft carrier model, while physicians have a more speedboat mentality as shown in the graph beside. The physician’s pathway is faster because it is different. It starts with observing and discussing individual cases, doing early investigational treatments with individuals, resulting in anecdotal confirmation of safety and efficacy, without using randomized, placebo structured clinical trials. This treatment therapy targets a singular person and is truly personalized. There is no claim that one is better than the other, it’s just different, and a physician also has to invest in an adequate infrastructure to provide the Point of Care treatment.

The information provided by ISSCR is therefore from our point of view rather a political statement regarding existing regulation supporting the drug market model, without recognizing the important pathway for patients as a medical procedure with unproven drug (= stem cell) treatments.

The TEXT published on the net by ISSRC:

The scientific and clinical communities have long been troubled by clinics operating around the world that market unproven stem cell “treatments” directly to patients.

It is particularly distressing that people often go to these clinics for relief or a cure for an intractable disease or injury, and can end up paying thousands of dollars for products that are not approved for use as advertised, have not been scientifically tested to know if they work, and can put their health in jeopardy. This includes procedures using the patients’ own stem cells (aka autologous use), which can also carry with it tremendous risk, even death.

Fortunately, several jurisdictions around the world are beginning to pay attention to the activities of such clinics. Efforts are underway to hopefully stop clinics from peddling risky stem cell treatments, and help patients by providing clear information about whether advertised stem cell products are safe and proven to work.

Regulatory Efforts in the U.S.

Recently, the U.S. Food and Drug Administration (FDA) announced enforcement actions against two clinics: it seized unapproved products from StemImmune Inc. of San Diego, California, and issued a warning letter to the U.S. Stem Cell Clinic of Sunrise, Florida. Both were providing “unapproved and potentially dangerous” stem cell interventions that put patients at risk. In the announcement, the FDA commissioner stated that the agency “will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures.”

The FDA also recently announced new regulatory and enforcement measures meant to more clearly define stem cell treatments that require agency oversight. The ISSCR, which has long advocated for such a move, issued a statement of support, noting that the agency will need additional resources to enforce the new rules effectively for the protection of patients.

Outside the U.S.

In Australia, the government announced it too will change regulations regarding the use of autologous stem cell interventions—those that are removed from a patient and then re-applied to that same patient. While those treatments had not previously been regulated, they are now brought into the regulatory regime, thanks in part to news reports

India also appears to be tightening up oversight of stem cell-based interventions, with the release of National Guidelines for Stem Cell Research that comes down strongly against unproven uses of stem cells. They admonish that “…every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”

New Legislation in California

These activities have not been limited to national regulatory agencies. A law passed in California in October requires clinics to inform patients if they are using stem cell interventions that have not been approved by the FDA. Clinics will be required to post a notice in their office and provide handouts to each patient, stating that the procedure has not been approved for clinical use.

Ensuring Stem Cell Products are Safe

As potential therapies are developed in the lab, and then made into products for medical use, they require careful review and testing to ensure they are safe AND effective.

This Closer Look at Stem Cells site includes accurate, scientifically vetted information about the potential of stem cell medicine and its current limitations. If you or a loved one is considering a stem cell treatment, review the ‘Stem Cells & Medicine’ section to learn more about what is known, and how to approach your physician with questions, before moving forward with any stem cell procedures.

Posted in BLOG, Stem Cell Therapy | Comments Off on Regulations………

Adult stem cell therapies the best kept secret in medicine!

Stem cell therapies and their lifesaving results are arguably the best kept medical secret.  Stem cells are currently being used in several thousand FDA-approved clinical trials, are treating tens of thousands of patients every year, and cumulatively over 1.5 million people have been treated to date.  Yet these numbers, and the lifesaving results from stem cells for dozens of conditions, are unknown to most.  Why the information blackout?  Perhaps for lack of an adjective.

You see, those heartening numbers are all due to adult stem cells.  Long ignored by the media and disparaged even by many in the scientific community, adult stem cells – those not dependent on the destruction of embryos – are the true gold standard for stem cells, especially when it comes to treating patients.

recent New York Times piece provides a perfect example of the disinformation campaign.  Early on, the author discusses the theoretical nature of stem cell treatments and bemoans the fact that “progress is slow,” almost all the research “is still in mice or petri dishes,” and “The very few clinical trials that have begun are still in the earliest phase.”

Whether through ignorance or bias, the sole focus is clearly on embryonic stem cells. Such writing, however, serves to confuse, not illuminate, the facts about stem cells and therapies.

Contrary to the blinkered portrayal of stem cells in the article, there are in fact almost 3,500  ongoing or completed clinical trials using adult stem cells, listed in the NIH/FDA-approved database.  Moreover, large numbers of patients have been treated with adult stem cells.  In 2012 there were almost 70,000 patients treated around the globe in that year alone, and almost 20,000 patients treated in just the U.S. in 2014.  Cumulatively, it’s been documented that as of December 2012, there had already been over one million adult stem cell transplants.  This means that now, over 1.5 million patients have had their lives saved and health improved by adult stem cell transplants.

Our focus is indeed on adult stem cells both because they are efficacious for patients, as well as because adult stem cells are derived without the destruction of the stem cell donor, unlike embryonic stem cells and fetal stem cells.  Both positions are based on the facts of biology.

The New York Times’ Kolata criticizes various “stem cell clinics” within the U.S., primarily via a paper by two long-time proponents of embryonic stem cells (though this is not disclosed in the article or in the paper), but paints a broad-brush across clinics operating legally and ethically as well as the shady operators. It then juxtaposes the critique of U.S. stem cell clinics with the tragic story of a patient who traveled to three different overseas clinics to receive “stem cell injections” and developed a growing mass of cells on his spine from at least one of the injections.  The implied warning is that all U.S. adult stem cell clinics are using similar methods, and, by extension, their patients may experience similar problems.  Indeed, many clinics are offshore to avoid FDA rules, but yet again the article drops adjectives and sows confusion.  The New England Journal of Medicine source on the case notes that the patient supposedly received proliferating cells including embryonic and fetal stem cells.  Certainly all clinics should operate within appropriate ethical and legal boundaries and patients should receive all information, including published background and whether the cells being used are adult, fetal, or embryonic; this is simply a matter of getting full informed consent.  But fear mongering and misinformation help neither the patients nor the science.

The stem cell science deniers continue to denigrate adult stem cells, denying their successes or even at times their existence by dropping the necessary, descriptive adjective.  But for patients, adult stem cells are the true gold standard for stem cells.  The hope of adult stem cells is being realized right now, for thousands of people around the globe.  Those stories, those doctors, those patients who have been helped by adult stem cell treatments, deserve to be heard.  People like Cindy Schroeder who thought she was given a death sentence when she was diagnosed with multiple myeloma.  But Cindy’s doctor was informed on the facts of modern medicine, and was able to inform Cindy and her family that there was hope—from adult stem cellsOver a year after her “stem cell treatment,” Cindy leads a full, active life and her family is closer than ever.  Her story, like that of thousands of others, is not theoretical; it’s real adult stem cell science.

The article by Dr. David A. Prentice, Research Director, Charlotte Lozier Institute appeared first on 22. of August 2016 in:

http://dailycaller.com/2016/08/22/adult-stem-cells-the-best-kept-secret-in-medicine/

Dr. David A. Prentice, is VP & Research Director for the Charlotte Lozier Institute as well as Adjunct Professor of Molecular Genetics at the John Paul II Institute, The Catholic University of America, and an Advisory Board Member for the Midwest Stem Cell Therapy Center.

Selected Comments:

SammyJo Wilkinson 

Dr. Prentice, this is a great summary of the disinformation campaign being waged against adult stem cells. I’d like to point out that those who disparage this therapy typically have vested interests in non-adult cellular research, but also engineered cells like Induced Pluripotent Stem Cells (iPSC). What they all share in common is patents on these techniques, and using your own stem cells offers no patent royalties. And none of it’s ready for human trial, while as you point our adult cells have been in use for decades to fight cancer, and are in trials now for hundreds of other conditions. To catch up they need more years in the research lab, funded by taxpayers. 

In the end this is a turf war by scientists trying to use scare tactics, because they haven’t produced proof their approach actually works. Citizens need to talk to their legislators about focusing research less on endless pre-clinical research, and focus on clinical human trials with approaches that are already showing safety & efficacy, like adult stem cells are. 

This article puts a number on it – 87.5% of biomedical-research money is wasted on a myriad of uncoordinated studies, with no accountability. This comes from Michael Bracken, a Yale epidemiologist, in a speech at the National Institutes of Health. Also backed up by an article in The Lancet, stating $200 billion (in 2010 dollars) is likely being wasted annual on wasteful science projects. Just think of how many lives could be saved if this money was directed towards treating sick patients with adult stem cells!

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Only 4 Adverse Events Reported Against 570 Stem Cell Clinics

A Freedom Of Information Act (FOIA) request, to the FDA, has revealed only 4 reports of adverse events / complains between 2012 to 2016 against a list of 570 U.S. stem cell clinics. When reviewing the list of complaint, not one patient treated by so-called unauthorised adult stem cell clinic´s was even involved in those complains.  

This low number of FOIA reports demonstrate that:

“There is clearly not an established pattern of harm of patients treated with adult stem cells, in the contrary the fear of potential harm seeded by some scientists referring mainly to embryonic stem cells and news media is becoming the basis of misinformation and should not have any place at the table of social or health policy”.

Here is the response to the official request, followed by links to the 4 reports.

Cc: “ORAHQ ACRA ESS FOI-DISCLOSURE STAFF”
Sent: Monday, August 22, 2016 2:45:07 PM
Subject: FOI Request 2016-6466

8/22/2016

Dear Requestor,
The attached records are being provided by the Office of Regulatory Affairs (ORA)Information Disclosure in response to your request #2016-6466 dated 08/08/16 for records from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:

ADVERSE EVENTS RE CELLULAR THERAPIES

Your request is granted in part.

After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under FOIA exemptions (b)(4) and (b)(6) of the FOIA 5 U.S.C. § 552, as amended and delineated below:

Exemption (b)(4) permits the withholding of “trade secrets” (TS) and “commercial confidential information” (CCI). Disclosure of this information would impair the government’s ability to obtain necessary information in the future and cause substantial harm to the competitive position of the person from whom the information was obtained. Under the balancing test of this exemption, we are withholding all proprietary information identified as TS and CCI.

Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.

ORA considers your request closed. If you have any questions about this response, you may contact Anna Postell at 301-796-6488.

Sincerely,
Anna Postell
Program Analyst

These are the adverse event reports:
APPLIED_Consumer Complaint 127882_Redacted.pdf
APPLIED_Consumer Complaint 131004_Redacted.pdf
APPLIED_Consumer Complaint 141021_Redacted.pdf
APPLIED_Consumer Complaint 144501_Redacted.pdf

Note: The request was granted in part, This doesn’t mean there are more than 4 records and the FDA is withholding them. It means the privileged types of information (b)(4) and (b)(6) are not provided, which you can see have been redacted in all of the 4 records.

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Approved cell and gene therapy products fail commercialization….

Cell and stem cell technology, especially when genes are involved, are an exciting new field in medicine, which from a scientific point of view can improve quality of life of human beings considerably.

Christopher Bravery – a consultant on advanced biologicals, has opened “Cell Therapy Stream of the annual Bioprocessing Summit 2016” with a worrisome statement:

Half of approved cell and gene therapy products on European market eventually failed commercialization and were withdrawn.

Here are the details, why he comes to this conclusion.

Since introduction in 2007 of regulations for cell and gene therapy by the EMA in Europe as Advanced Therapy Medicinal Products (ATMP), the following seven (+1 to be) cell and gene therapy products were approved by EMA:

  1. Chondrocelect by Tigenix in 2009

  2. Glybera by uniQure in 2012  – Market price: 1.1 Million Euro

  3. MACI by Genzyme/ Sanofi/ Vericel in 2013

  4. Provenge by Dendreon in 2013

  5. Holoclar by Chiesi in 2015

  6. Imlygic by Amgen in 2015

  7. Strimvelis by GSK in 2016 – Market price: 594.000 € with money back guarantee in Italy!!

  8. Zalmoxis by MolMed in 2016 (not finally approved yet as of today)

Now, let’s look at their development in the market:

  1. MACI’s (3) authorization was suspended in 2014, just after being 1 year on the market.

  2. Provenge (4) was withdrawn in 2015, i.e. after  2 years being on the market.

  3. Chondrocelect, (1) withdrawal has been starting in 2016, after 7 years on the market.

So, 3 out of 4 (75 %) purely cell-based ATMPs or 3 out of 7 (43 %) of all approved ATMPs were withdrawn in the last 3 years! If we in this review exclude Zalmoxis, which yet has to be approved, the statistics will be even worse.

If we furthermore also exclude Glybera, a cell product which comes with a price tag of 1.4 Million US-Dollars per treatment, and which was administered only once in the three post-approval years and widely considered as a commercial flop, due to reimbursement problems, the above statistics will be much worse.

So, Christopher Bravery asked, is commercialization the solid case of failed ATMPs. Well, at this point, it apparently is! He, in his review was, however, emphasizing on “at this point”, because just only 7 approved products is not a big number for a statistical analysis besides, besides 4 products were only approved in the last one year and half – not long enough for a deep analysis of a market performance.

On the other hand 7 products approved in the last 10 years have also shown that the promise of advanced medical treatments with cell and stem cell therapy is not realizing as fast as it was thought by many.

Nevertheless, the question is “WHY is cell and stem cell treatment not being quickly applied in medical practice, and why commercialization of cell-based products is failing”? Christopher Bravery asked the audience: “Do we focus too much on regulatory approval, but not enough on commercialization?” Yet another question he asked: “Are we choosing the right indications?” Of course, it is important to analyze each case of failed commercialization and post-marketing adoption, but it does not explain alone why cell and stem cell treatment in Western Countries in spite of clear scientific advances and favorable safety reports is not applied in patients. All three mentioned withdrawals were initiated by the companies, manufacturing and marketing the product, but not by EMA according to Christopher Bravery. So, very clearly there is nothing wrong with the safety profile of these ATMPs, so much so more at the time of approval these ATMPs were deemed as “efficacious” in their intended applications.

However, the market is harsh. Sales were not as good as expected and companies were making business decisions. Were developers over-optimistic at the time of approval? Christopher Bravery think´s so and so do I. Didn’t they account for competitors, with favorable alternative technologies and reimbursement issues? Obviously not that deeply! In any case, as of today, it seems like, most of cell and gene therapies in Europe are not commercially viable. We have a lot of lessons to learn from these failures.

As I am also consulting in this field, I have asked myself often the questions “How can we bring new emerging cell and stem cell technology successfully to the market” especially in view of the cost of developing new medicinal products which had been skyrocketing in the last decade, to about 2.6 Billion US-Dollars per development and application, beside the long approval period of more than 10 years!  See also the link:  http://www.bioworld.com/content/tufts-study-cost-develop-new-drug-balloons-26b-0

I believe that Western Countries are too much focused on the “somewhat outdated model of regulatory approval for new cell and stem cell based medical products. The regulatory concept for the allopathy treatment model was and is still today adequate for approving medicinal products for human use. Technological advances, however, are giving us the tool to treat patients different, than just with mainstream medication, approved by regulatory.

The global increase in “Complementary and Alternative medicine / CAM” is indicating the dilemma physicians are facing. According to a recent MAYO clinic report about 40 % of patients are trying to find additional support with CAM therapies as mainstream medication does not improve their medical condition.

Cell and autologous Stem Cell treatment from my point of view is part of this so-called CAM therapies, which puts all involved into a difficult regulatory “Dark area”! I believe it is time to follow more strongly the philosophy of “medical treatment with investigational character ” in the responsibility of a physician than let regulatory and industry try to find a solution by modifying, basically  copied natural process, highly manipulated, to eventually provide physicians with a “treatment in a bottle “ which may fit a large treatment spectrum.

Cell and stem cell technology is a disruptive technology, which changes the treatment of diseases as we know dramatically, and like with all changes there are strong movements to find ways to maintain a “status quo”! The Result is, that in reality in the last ten years since FDA / EMA are regulating this new therapeutic field basically none of the products initiated by industry are really successful and that patients are finding ways to bypass this situation by engaging in medical tourism to places where they potentially find help to improve their condition.

I have seen good and less successful treatments, but in the end, with traditional approved medicinal products we have the same situation as clearly indicated by the government statistic in respect of adverse events of approved drugs.

From my point of view, we have to find a way where regulatory supports new technologies and its application without overregulating it, due to safety concerns in respect of potential treatments of patients. Unfortunately, the regulatory environment is becoming even more complex as regulators try to enter the domain of “medical procedure” with guidelines not being helpful for the further development of cell and stem cell related therapies. According to the FDA /EMA, guidelines are not binding, but on the other hand FDA / EMA can issue warning letters when guidelines may potentially be violated. This situation, intended to clarify the application of this new technology, unfortunately, has increased the uncertainty of treatment with cells and stem cells.

Until this is not changed, we will have medical tourism to countries supporting those new technologies where certified clinics and doctors, are advancing with new application of scientific knowhow, not yet approved by western regulatory agencies.

A good example is autologous stem cell treatments. Tens of thousands of patients had been treated globally already with autologous stem cells for various conditions. It is proven that there was no adverse event in any of the treated cases. FDA / EMA is not adjusting its regulation for those new technologies. Can there, will there be a problem with this kind of treatment, of course, there will, like with FDA / EMA approved medical products. Medical doctors are always trying to help patients in their medical need, but they are not always successful! Why are we pretending that mainstream medical treatment is different than investigational medical treatment in this respect?

As mentioned before, the way out is to be more open minded and to adjust the approval process by separating highly manipulated modern gene, biological and chemical based technologies from those easily performed at a physician as a medical procedure with own, autologous cell and stem cells.

In Europe, PRP treatment is considered not to be an advanced therapeutic medicinal product and can be used freely, whereas autologous stem cells are considered as ATMPs and therefore has to be following the clinical trial concept before used in human application.  This shows clearly that regulators do not understand the new technology as they rule old and new with the same regulation, blocking clearly scientific advances.

As long as the discussion “standardized medical treatment with industrial GMP processed patented products” versus “personalized treatment with autologous cell and stem cells as a bed side treatment by a physician as a medical but not product procedure” is not fully separated in the regulatory framework, medical treatment advance will be applied in countries where this concept is understood and regulated accordingly, like Japan , Australia, many other Asian countries, but also Panama, Mexico or the Bahama,  not following the somewhat outdated regulatory framework, but already adjusted it to support the new medical treatment technology.

The dilemma and poor result of R&D effort and its commercialization with regulated advanced medical products (ATMPs) is well documented by the review of approved ATMPs in Europe, by Christopher Bravery and a clear indication why we in Western Countries are facing a growing medical tourism, or even a kind of underground treatment activity, while the industry and sponsored scientific institutes claims, that doctors performing increasingly treatments with so-called unproven products and methods.

In our today’s globalized environment, patients have the possibility to find help in their “unmet medical need” by searching the digital information world available 24-7-365 times, and ONLY need to look for qualified clinics, as autologous cell and stem cell treatment had been proven all over the world to be safe and at least partially effective as documented in thousands of anecdotal studies and individual testimonies have shown.  

An anecdote is a story, and according the mainstream medicine not a study, as it refers to an individual’s experience with their disease or symptoms and the effort by a physician, often applying complementary and alternative medical treatments to treat a medical condition. People, but also modern, open minded physician, generally find anecdotes highly compelling, while regulatory agency and the allopathy trained scientists and doctors are deeply suspicious of anecdotes, claiming that they are not controlled studies, i.e. following the clinical trial route, and therefore cannot be considered as evidence based studies, like done with regulatory approved medicinal products.

Well, on 3 December 1967, South African doctor, Dr Christiaan (Chris) Barnard, performed the world’s first human to human heart transplant,  Dolly the sheep, on July 5, 1996,  was the first mammal to have been successfully cloned from an adult cell. If regulatory would have been involved, this never would have happened, besides it was anecdotal, and today it has opened up a huge new field of applied science, where heart transplant is after 50 years accepted as a medical option by mainstream medicine. Dolly was cloned by a team of Scottish  scientists at the Roslin Institute, part of the University of Edinburgh, Scotland, and Cloning a mammal defied the scientific dogma of its time. The success led to dire and fantastic predictions: Humans would be cloned. Diseases would be prevented. Lost children rebirthed, resulting that regulatory agencies all over the world started to define what maybe ethical cloning and what not. Today we can say that Cloning has had a bigger impact on science, but a smaller one on human life, than many expected. What will be considered as “normal” is time dependent and what will be in 20 or more years from now, who knows?

The only thing to add to this is, wherever you are, whatever your profession is, if you have not yet understood that everything has a life cycle, and changes are a continuous process of life and environment, please visit an open minded medical professional to  “Welcome you to the constantly changing 21st Century environment”!  

 

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Brainwave Entrainment iSLRS

The iSLRS,
……… the integrated Sound and Light Relaxation System

In the modern world we live in, things are getting faster and faster and more and more stressful, which can really take a toll on our health, creating insomnia, depression, fatigue, and sickness. Prescription and recreational drug use is at an all-time high along with alcohol and other unhealthy coping mechanisms for this stress, but they all have unhealthy side effects.

SwissBionic / Mediconsult has certainly a better solution with “The iSLRS, the integrated sound and light relaxation system”

iSLRS -03

The iSLRS is probably best described as a “healing spa for our mind” and works seamlessly with the iMRS mat to provide the relaxation frequencies via light and sound that will melt away stress, increase oxygenation in your brain, deepen your ability to relax, restore healthy sleep and alleviate depression and improve emotional balance.

The iSLRS is simple to use and connects easily to the iMRS control unit. Simply plug in the goggles, headphones and SD card and begin the session as you usually would do so. Lay down, breath deep and relax and feel your body become more energized and rejuvenated.

…………………………………..The iSLRS comes with the following features:

iSLRS -01

 What is the technology behind a Light and Sound System?

 A light and sound instrument is a mind entrainment tool. The method by which this entrainment occurs is known as the Frequency Following Response (FFR). Through the use of audio (headphones) and visual (eye frames with LEDs) stimulation, listeners are gently guided into specific states of mind. Each audio beat and light pulse is a specific frequency. Our minds “think” in terms of frequency.

Brainwaves change frequencies based on neural activity within the brain, be it by hearing, touch, smell, vision and/or taste. These senses respond to activity from the environment and transmits that information to the brain via electrical signals. Hearing and vision are considered the favourable senses for affecting brainwaves safely. By presenting these beats and pulses to the brain, within a few minutes, the brain begins to mimic or follow the same frequencies as the stimuli (the beats and pulses).

This process is referred to as entrainment. In essence, these instruments speak to the mind in it’s own language, the language of frequency.  – Scientific Source *1

This “language of frequency” is exactly what the iSLRS does and it does so with additionally synchronizing with biorhythm clock of the iMRS and the frequencies in the iMRS mat. So in the morning you get predominantly energizing or BETA frequencies and at night before bedtime you will get theta/delta frequencies.

Beta-Waves (above 13Hz, at center about 14-16 Hz)

These waves determine brain activity during awake, tense and active conditions. At the  forefront  is  the  consciousness,  influenced  by external  stimuli, the processing of

mental impressions and critical thinking.Within the constructive beta area, a condition of elevated concentration is present. Elevated frequencies past a certain limit cause destructive conditions such as stress, fear or even panic. Overly elevated beta-wave-shares cause a higher output of stress-hormones.

Alpha-Waves (8-13 Hz)

They appear in a relaxed condition when the eyes are closed in the stage between sleep and waking hours. Characteristics are pleasant relaxation, positive mood and a feeling of “body and spirit” integration.

Theta-Waves (4-8 Hz)

They usually develop during sleep, dreaming and deep meditation. The formation of the sub-consciousness is now active.

 This zone is characterized by vivid imagination, improved learning and recollection ability, fantasy and intuition.

Delta-Waves (0.5-4 Hz)

They appear mostly during deep-sleep and are rarely experienced during wakening hours. The accompanying psychological conditions are a dreamless sleep, trance and deep-hypnosis. Delta waves are of great importance for healing processes as well as the functioning of the immune system.

The new iSLRS furthermore, comes with 3 colors (RED, GREEN and BLUE) that will provide an ideal light therapy for different times of day and needs. For example, red is associated with the sympathetic nervous system and can be used to energize and stimulate the body. This would be ideal for the morning or anytime you need extra iSLRS -02energy and stimulation. Blue is the opposite, it affects the parasympathetic response and helps promote relaxation and rest calming the body and lowering blood pressure, heart rate, breathing , etc. It would be the ideal color for the evening or before bedtime when you want to be relaxed.

Green is a general health promoting color and is balanced, so it would not be overly stimulating or relaxing. Its a very good color for the heart and promoting overall health

So the iSLRS not only entrains, balances and energizes both sides of the brain and full body synchronized with iMRS mat, it also gives you color therapy, also called chromotherapy.

iMRS inspired by Nature, backed by science, registered at regulators

iMORE picture 5

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MEMBERSHIP AREA

WELCOME TO THE MEMBERSHIP AREA OF 

ARI LOGO 9

As a member of the ARISTOLOFT membership site, you will have the possibility to explore, review, see special prices for equipments and holistic and alternative medical treatments to support unmet medical needs with investigational and experimental medical concepts reflecting advanced scientific Know How of the 21st Century.

Our activity is based on the scientific understanding that:

Humans are a complex biological  system of about 100 Trillion cells, embedded  in  an  electromagnetic energy field, communicating with  its  specific  neural  network, able to  exchange and  analyze  information  and  with this, initiating impulses triggering biological, electrical  and chemical related reaction at its cellular basis.

This natural, regenerative capability is decreasing over time with aging, but can be influenced and enhanced by stimulating the body’s own defense system.

The holistic approach  with  Stem Cells,  pulsed electromagnetic frequency and information field therapies,  supported by Brain Wave Entrainment technologies  of the  21st Century AND Jeunesse supporting health from the inside out and the outside in, with  the Worlds first adult stem cell based Skin Care, Nutrition & Hormone balancing Weight Management portfolio has been showing incredible results in supporting health at its cellular level.

Our mind and the body´s regenerative capability, are able to perform health maintenance as never imagined before. 

Please kindly understand that we are providing this information in the frame of alternative and holistic medication for educational purpose only, as data is based mainly on Anecdotal studies, and surgical procedures which means that they are not registered clinical studies, but has been conducted by scientists and physician to review safety and efficacy in single or more cases with impressive results and no side effects, nor reportable serious adverse events. 

Our membership area is subdivided into five sections:

1.  Autologous stem cell treatments
2. Energy – PEMF Therapy
3. Energy – Information Field Frequency Therapy  (under preparation)
4. Brainwave Entrainment specific support at Network Marketing
5. Jeunesse
6. Network Marketing training and tools for key distributors of Aristoloft

After registration you are able to visit those specific sites free of charge and obtain all information for free, EXCEPT our Network Marketing training tools for key distributors.

Network Marketing training and tools are only available for key distributors of Aristoloft. In order to become a key distributor, you have to register your activity with Jeunesse via Aristoloft,

http://celltheraphyaristoloft.jeunesseglobal2.com/default.aspx

purchase the Ambassador package and enroll in “unconditional autoshipment” with a product of about € 75.00 (month), which gives you 60 CV points / months. This will maintain your distributor status in respect of rank qualification and guarantees that you are eligible for commission from your network.

In return you will participate in a personalized training, with once a week Skype / Zoom session and supporting material to develop your distributor skills, to reach potentially in 100 days the rank of a Sapphire at Jeunesse. If you are willing to learn and follow our duplication strategy you have a change to build an own successful and sustainable business. We are not looking for “distributor sharks” building a network in a few weeks without a sustainable structure, we are looking for professional dedicating time for developing a solid customer and distributor basis.

Disclaimer.
Please note, for regulatory reasons, there is a disclaimer on all our Social Media Pages of Aristoloft,  including but not limited to, our Facebook pages and related Web sites, showing that all data is for educational purpose only and that these statements have not been evaluated by the FDA (Food and Drug Administration) or similar health organizationsProducts mentioned and medical information referred to are not intended to diagnose, treat, cure, or prevent any disease and as with any personal and anecdotal testimony application, results may vary. Information about business success, like reaching a certain rank in the business structure, is based on personal commitment, time invested and selling skills, and as success is personal, there is no guarantee for individual  success. Success starts with “Let´s do it” and the way you master the hurdles in front of you. 
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