After Japan, the US is advancing in adjusting its Stem Cell Regulation

Members of the US Congress are taking leadership on this issue.

Cell therapy, which involves the use of cells to restore healthy function in the human body, represents one of the most promising areas for the next generation of ground-breaking treatments in the 21st Century. Cell therapies have been shown to halt the progression of degenerative joint disease in the knee or hip and restore function to even a failing heart or damaged cornea. 

Scientific advances in the field include applications in cardiology, neurology, oncology, ophthalmology, and orthopaedics and there have been also promising studies for those with Alzheimer’s disease, Parkinson’s disease, diabetes, and cancer. Cell therapies are different from drugs in that they attempt to address the root cause of disease, rather than simply treating the symptoms of disease.

A human body consists of more than 100 trillion cells, communicating with its neural network by analysing and initiating needed activities at its cellular level. Every minute we are regenerating about 1,7 million cells, and like planet earth, raw material, i.e. cells produced in the bone marrow are not unlimited available as we all experience with aging.

Malfunction of a body, treated traditionally on the level of symptoms, can be treated at their roots with regenerative personalized stem cell treatment having a chance to support the body´s own defence system to repair damaged areas. Own stem cell treatment has shown in thousands of patient funded investigational studies that the treatment is safe and has the potential to improve the quality of life of patients considerably.

Despite the scientifically proven benefits of these treatments, cell therapies are generally not accessible to patients in countries following the outdated general drug related regulation for autologous cell therapies, an approach which is valid for therapies with highly manipulated chemical and biological based drugs, where side effects has to be carefully reviewed.

As a result, it takes on average more than $1 billion and ten to fifteen years of investment in development and clinical trials before drugs including autologous cell therapies can be brought to patients, besides those patented products are extremely expensive stretching the national health budgets beyond its already limited capacity.

For instance, Prochymal (its old name under Osiris) that is now rebranded as TEMCELL from Mesoblast/JCR likely will cost about $ 200K for a full treatment for GVHD. Provenge, the cellular prostate cancer drug from Dendreon is coming with a price tag of $ 93K. The most expensive drug in history, the gene therapy med Glybera will cost around $ 1.5 million per patient, and the first-ever human study of a treatment that uses reprogrammed adult stem cells in Japan according to Japanese source are believed to be in the range of $ 500 K per treatment.

It is most likely that FDA approved stem cell therapy in the average will cost somewhere between $ 100 K to $ 200 K per patient. The yearly cost of advanced cancer treatment is in the range of $ 100 K per year, and modern oral biological treatment of multiple sclerosis is $ 92 K beside the additional cost due to unemployment and additional medical care services.

The alternative, a medical procedure with own stem cells, has not only the advantage to be safe, as we are giving to the body what is from the same body, and therefore will not face immunoreactions, but will support the natural capability of the body to regenerate at its cellular level at $ 10K to $ 25K per treatment.

Autologous stem cell treatments appears to be more cost effective as it is personalized, is readily available and has a proven safety record. The question why there are so few clinical trials is relatively simple to answer. Drug development and clinical trials are usually sponsored by the Industry and by government agencies. Products which will developed via this clinical trial route will be patented by the developing and marketing company before it is marketed to recover the investment costs.

Autologous stem cell treatment is personalized, there will be no patent on the medical procedure and therefore neither the industry not government agencies sponsor those clinical trials. The only alternative to advance this field are patient funded investigational studies which will prove the feasibility of the medical concept. Blinded studies are not part of the patient funded investigational studies, in the frame of practice of medicine, as the patient expect at least a small benefit from the treatment.

Here are three videos from TIME WARNER TV NAINAMD reviewing various autologous stem cell treatment possibilities and its cryopreservation available today:

  1. TIME WARNER TV NAINAMD hosts Dr. Georg Graf on stem cells

  2.  TIME WARNER TV NAINAMD hosts Dr. Mark Berman  on Stem Cells

 

  3. TIME WARNER TV NAINAMD hosts Dr. Elliot Lander on Stem Cells

Japan has realized that the present drug regulation for stem cell treatment is outdated and have adjusted its regulation already avoiding the long and costly development via clinical trials as regulated for chemical and biological drugs. Other countries like the US or EU are still reviewing its regulation in general, although physicians have advanced in the frame of a medical treatment with minimally manipulated autologous stem cells with interesting positive results and no side effects!

Recent developments, recognizing the benefits of autologous cell therapies, numerous organizations and experts in the US, including the Regenerative Medicine Foundation, the Alliance for the Advancement of Cellular Therapies, and experts and leaders involved in the Bipartisan Policy Center, have called for a new framework to accelerate the availability of safe and effective cell therapies to Americans in need and improve U.S. competitiveness in the global marketplace.

Several members of the US Congress are taking leadership on this issue. Senator Mark Kirk (R-IL) and Senator Susan Collins (R-ME) have drafted legislation that would help advance safe and effective regenerative cell therapies through the FDA approval process and to the market so that patients can benefit from them.

Briefly the draft refers to: 
Adult stem cell both 361 low dose and 351 high dose, including Cord Blood UCB and suggest the acceptance of:

  • Interstate commerce and cell banking

  • Non-homologous use

  • Five year conditional approval for both 361 low dose and 351 high dose, after Phase 1 safety review passed and skipping Phase 3.

    Sponsor shall apply and pay for a BLA (Biological License Application) after the 5th year of marketing, which is $750K if approved.

The medical society and stem cell advocates are welcoming this development, which may help to improve quality of life of patients considerably where standard medical treatments has shown no further improvements of patients.

As after Japan, now also the US is trying to change its outdated stem cell regulation, and we hope that EMA in the European Union will open up further its advancement in treating patients with stem cells.

If you are interested in a patient funded autologous stem cell treatment please contact us to review whether you could become a potential patient for this kind of treatment. Further details please see at Cell Surgical Network or Cell Surgical Therapy.

Disclaimer:
Please note, for regulatory reasons there is a disclaimer on all our Social Media Pages of Aristoloft and CellTheraPhy Aristoloft including but not limited to our Facebook´s and 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 organisations. Any of the products / services are not intended to diagnose, treat, cure, or prevent any disease and as with any personal and anecdotal testimony, application results may vary.

 
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Network Marketing a great fit for entrepreneurial cell and wellness clinics!

THE ENTREPRENEURIAL MIND-SET………

I am considered by some, who worked with me, as relentless. What does this really mean? Well, I think it maybe the understanding of a certain mind-set and people often see activities as “relentless” because they feel the motion but do not see that the action behind is leading to a visionary goal.

If you measure however, your progress by “accomplishing a goal” and focus on goals, I believe you have an excellent mind-set, a mind-set of an entrepreneur, and if someone consider this being “relentless”, well, then I am, but keep in mind:

“The key that unlocks energy is Desire.”
Earl Nightingale

An Entrepreneur, a successful entrepreneur, is from my point of view, a multitasking personality, result driven, open minded, having a vision of the future, is self-motivated, see obstacles as challenges to conquer, but also understands the need of discipline, which I, still with a human caring touch, proudly practised very successful in my last 30 years as Managing Director of various subsidiaries of a globally operating chemical and pharmaceutical enterprise in very competitive environments.

I opened up, for and with this company, successful subsidiaries in South Korea, Taiwan, a complex Japanese – European production Joint Venture in Singapore, closed corporate activities in Liechtenstein, UK and Canada and changed business to fit better in the new business environment in Malaysia, Germany, Hungary and Portugal, but also developed and established a foundation. Relentless? No!, Just goal driven, having the desire to achieve something that changes something for good, and not afraid of the challenge even though sometimes the way to succeed is not clear, but with time “the how to achieve the goal” became and is becoming clearer and clearer!

I always knew, the most important step is always the first step.  A journey of a thousand miles begins with a single first step. I truly believe, nothing is more exhausting than the task that’s never started, a great dream, that turns into a nightmare. Strangely enough, I have seen that starting is often more difficult than continuing, therefore I always told my team, don’t try to make whatever your task is perfect, don’t try to hit the 100 percent mark, before you start, because like this, you might never really start, therefore, just get it going even when you reached only 80 percent of what is needed! You will develop the missing percentage on the way! Once on the way give your activity the 100 percent it deserves.

In 2006, I envisioned, and without knowing how, I started and eventually created a foundation in Portugal and served until 2011 as its president to promote science and art, by bringing them together in exhibitions under the umbrella theme of “Esperança de Vida” to sponsor young artists and health related associations. With it’s proceed, the foundation assisted individuals with medical problems, and associations to help treating better Multiple Sclerosis, Cancer and Rare Diseases.

After my contractual corporate retirement in 2009, I developed my own consulting business at Aristoloft Ltd, first as a financial arm of various personal real estate activities and basically in parallel as a consultancy with the vision to support, develop and establish alternative health and wellness treatments, based on new cell and stem cell related investigational Know How of the 21st century.

Well, I always had this vision that technology will change medical treatment as we know, and for most knowing me, it was clear, I obviously could not, did not really retire in 2009, probably because I was and am still too much involved in exploring new things, improving my skills and supporting others, the seed of an entrepreneurial spirit. I felt and feel inspired by some wisdom of those people dealing mostly on the subjects of human character development, motivation, excellence and meaningful existence like Jim Rohn, Bob Proctor, Tony Robbins or Earl Nightingale to mention a few. This philosophies are well expressed in one of Earl Nightingale´s quotes:

“The more intensely we feel about an idea or a goal,
the more assuredly the idea, buried deep in our subconscious,
will direct us along the path to its fulfilment.”

Humans are by nature curious, which is the main basis of evolution and development and this is built in, in my holistic health and wellness philosophy. Nightingale´s quote reflects the path I am going since long and each time more, as the technological understanding of what is a human body is becoming clearer, more transparent! Humans are inspired by the new technological advances and on their unstoppable way to take the next step in evolution!

In this understanding, the collective collaboration of cells inside a human body, and the learning of how our cell structure is embedded in the environment, is obviously a main basis of forming our conscious and even more our subconscious mind.

Therefore, I have defined humans according to this mind-set, as being a complex biological system of more than 100 trillion cells, embedded in an electromagnetic energy field, communicating with its specific neural network, able to exchange and analyse information at cellular level. With this constant review of our cellular structure, this network is initiating impulses, triggering targeted biological, electrical and chemical related reactions at its cellular level as the cell structure knows, at which level there is “a malfunction, a problem” and use the natural build in regenerative capability, to “solve this cellular problem”.

We all experience, that this natural capability is decreasing over time with ageing, but new science has shown that it can be influenced and enhanced, regenerated by stimulating our body´s regenerative system using our new understanding of how cell and stem cells communicate and regenerate. Consciously, we are not really aware that our cells are constantly working to maintain health at cellular level by regenerating our cell structure at a path of about 1.7 Million cells per minute, showing clearly that we are a biological structure with a build in repair system!

My holistic health and wellness philosophy is reviewing and supporting this build in repair system with technologies as shown in the picture below,

21 Century Holistic Medical treatment - Falk

and my main consultancy activity is defined as:

“Helping people in their health maintenance
to become and stay fit, while aging
and in becoming financially free!”

This last part of my vision statement “becoming financially free”, usually results in: “You do what?” What has health and wellness to do with financial freedom?

It’s undoubted an interesting question and subject, and usually it opens up the opportunity and admits time to explain, how I am helping people in respect of their health and wellbeing, by bringing together the 21st Century new cell and autologous stem cell based related treatments and cell based maintenance products available via network marketing.

Most people, during the course of explanation, react like, “Well, you are involved in serious scientific activities, obviously since long, but how come that you at the same time involve yourself in the infamous Pyramid marketing system?” Well, I have to admit, it’s a question I faced in the beginning too, and only recently understood the mistake I made by accepting standard information without reviewing it more careful!

Well, its history, but somehow, I record, that there was many years ago, once a time I touched shortly the subject, even having been successful at senior management level for more than 3 decades in doing business in the traditional corporate activity.  I guess, I always looked a little bit out of the box and realized that in the late 20 century, the existing corporate business model faced many challenges, including those of motivation in sales and marketing, beside the costly infrastructure of doing business as usual.

Most, especially large global operating companies, are however defending their business model and potentially are afraid to change to a model where control with real customers is not anymore in-house. I recall a meeting where there was a brief discussion on direct sales, but as there was the bitter taste of the Pyramid system, being a financial sales scam, I also remained very sceptical even to review this sales and marketing option further.  

I suppose, if I, maybe better we, the corporate, would have been less successful, we might have looked also more serious to sales and marketing alternatives and reviewed and understood the potential of Network marketing better. But, as mentioned before, why should I, embedded in a large global corporation changing the business model while working successful, besides this, the other potential alternatives appeared just not attractive enough to be considered as a viable option! Well, I guess it was not yet my time to enter this activity!

The new model of doing business direct with customers as “Direct Sales” developed, however nearly unnoticed by many corporation and established strong, sizeable structures in the last decade of the last century.

Many companies and managers realized only late, what kind of interesting tool was developing globally, although it had its challenges, especially as some companies in the late last century with their trial and errors philosophy, developed the infamous financial pyramid system putting unfortunately a big question mark to network marketing activities in general in that time.

This financial Pyramid system has however nothing to do with the, by now well-developed, direct selling marketing activities of well-structured enterprises, as in the beginning of the 21st  century, this business model overcame it growing up pain and irritation phase. Today, this business model can be considered as a mature and attractive business model. Companies, which started some years back to develop seriously “Direct Sales, and Network Marketing or Multi level Marketing (MLM)” became solid enterprises in the new emerging business environment in even less than 10 years!

Here is a short explanation I learned during the review of the difference of MLM and Direct Sales.  Direct sales can be understood as face-to-face selling. Products and services are presented to consumers at work or home by an independent salesperson, where the salesperson earns the difference between e.g. the wholesale price and the recommended retail price. Multilevel marketing is not actually marketing, but an additional technique to systematize and compensate direct salespeople. According to the World Federation of Direct Selling Associations (WFDSA), multilevel marketing is, better described as being a direct selling compensation plan where independent salespeople receive payment in a variety of ways. Good direct selling companies compensate their independent distributors with a solid retail margin of around 30 to 40 % for their direct sales and own consumption and in addition compensate those building a network of own but independent sales people with interesting additional commission and other incentive plans.

Well, as I did not know all this information about Network marketing, nor bothered to review it further in that time, as I lived well by developing and defending quit successful corporate business the old way over many years. The acceptance and entering eventually this activity needed clearly a change of mind-set! As our environment, the world in which we live and work, is a mirror of our attitudes, the learning and the constantly changing horizon, sooner, rather than later, this network marketing idea would fall on me and confront me seriously, and my past very superficial review would not be helpful!

When I started to develop my holistic health and wellness concept further in 2010, and reviewed many companies and options, I made some painful discoveries and experience. Nevertheless I slowly, eventually found the right partners and while developing my business and researching for additional products in the field of wellness and antiaging, one day in November 2014, an Australian friend of mine contacted me, drawing my attention to Jeunesse a stem cell technology based skin care and nutrition portfolio Company. I had, by that time, already developed well my holistic health and wellness concept as shown above, but the third column, “Nutritional Support” though envisioned, was still without any real activity.

He got my full attention, when he explained that one of the nutritional products is supporting Telomeres, the endcaps of our chromosomes. I was looking since some time to find a registered supplier in Europe for TA 65, the only patented product which is clinical proven in maintaining and even increasing in some instances the length of the telomeres in our chromosomes, which in turn means healthier cells and healthier cells mean a healthier body. Unfortunately no supplier did register the products with the European health regulators, so the product was basically only available in the US.

But when he explained, I can get this product now via Network Marketing, immediately several flash lights started to show up in my mind, as I associated network marketing with words like Pyramid scheme and sales scam. This were really words that came immediately to my mind and I told “my friend off”; — You know, I like the products but sorry, do not want to be involved with one of “those pyramid scheme people.”

My life was embedded, as mentioned before in a very successful corporate and now consulting activity and adding a stem cell based skin care and nutrition portfolio would support my activity undoubtedly, but the prize, joining a “network marketing scam” is out of the question!

I remember, I actually said, ”scam”, after all, I have heard about it, and I felt it is not really an attractive idea to my sincere science based activity, especially after my friend mentioned the potential of the multiple six figure income, as this usually was indicating the sales scam!!

I, immediately also jumped on his last phrase and said, you see, here the scam already begins, creating big hope based on “hot air”, therefore,  I do not think, network marketing is what I like to be involved with.  I behaved like the guy in the cartoon below, who based his knowledge on not reliable or better outdated information ……. see the video, get enlightened!

Well, good friends have, – sometime, – patience with their friends, and those are really good in Network Marketing, obviously don´t take “NO for an answer”. In the end, after several months of not touching on the issue, we came back to it and he explained, well, you are right, in the past we had this kind of companies in this field, but time is passing and today it’s the 21st century, it is much different than even a few years ago, technology has supported the change in a way people never thought about before!

Have a look to the cartoon regarding network marketing and the pyramid system, see it until the end, it’s a good training for open up the mind of people….

My friend emphasized further, “You are working in a very advanced science field, you know that technology is changing quickly and the concepts of bringing products to the market are also changing dramatically”. Many companies who did enter the market via network marketing have established by now valuable distributor networks with entrepreneurial people to the benefit of both sides.

Instead of using 40 plus percent of revenues for an own sales infrastructure and advertisements, those values are distributed by good network marketing companies, to those regular customers and distributors to compensate them for their involvement and direct sales efforts. If a company has a certain profile you can be sure, that you can enter a successful partnership with very little investment and basically no risk, compared to a franchise system, and make either some interesting money, by starting part-time, just to see how it works, or benefit from purchasing the products at wholesale prices for own use!

I am sure, it also would work out for you, and it might be more rewarding in the end for many of those people being fully involved, by building own teams in Direct Sales.

I know you personally do not depend anymore on developing a new income stream, to support your lifestyle, you live well in two different countries, travel the world, have a great marriage and nice kids, but besides the passion for your great science based activity, the only side effect is, it fits well into your vision to help people.

Look, here are the main point´s based on the latest review, or better test result of profiling well a good network marketing company. This points are helpful to analyse the activity before entering and I highly recommend to see, also for anybody interested in Network marketing, the video by Eric Worre, explaining in his video “The Rise of the Entrepreneur”, well the future of network marketing as well as the four below mentioned important cornerstones for selecting and partnering with a successful Network Marketing company.

1. Products and Services.
Here you need to answer the question: Is there a need in the market?; Does the Product meets this need?; Is the product priced to sell, can it compete in the market place?; Is it priced for profit, i.e. is there enough margin for the company and the distributor to generate sustainable income?, and last but not least do you like the product and services offered?;

2. The Company.
Here you should review: Is it well run?; Do you believe in the management team, and the founders?; Is the science story behind the products solid?; Are there ideas, a vision of additional products in the same market segment?

3. The Compensation Plan.
Here you should focus on the question: Can a new distributor generate quickly some income?—to show success to him and others to believe it’s a step in the right direction!; Is the entrance barrier, subscription fee competitively priced?; Is there a possibility to develop a moderate part-time income in a reasonable period of time and with time develop an own network to enjoy the full benefit of the compensation plan?; and for those who really like to go “PRO”, is there a real possibility for a serious full time income if someone works hard, is committed and develops skills necessary to succeed! People, who think, they will become rich over night without work, will fail, but not only in network marketing!

4. Support.
Well, if you are comfortable with the product, feel well with the company and the compensation plan, the last point, important for a final decision, is the support you receive if you join as a distributor, not only from you up-line. 

Good Network companies have a great website, an on-line reporting tools / back office, and have outstanding training programs and host events to support distributors to build their business.

Choosing and joining a network company is of course a very personal decision but evaluating the above four main elements is a great start.

Well, what do you think? I am certain you will agree, when analysing these few points with your consulting philosophy, that Jeunesse is a solid company and shall become an even  stronger power in future with their anti-aging product portfolio and their appealing direct selling strategy. 

My friend, I accepted your sceptics, it’s what I encounter every day, but please reflect, you are an entrepreneur, able to analyse new developments, learn new skills and most importantly be open minded. You certainly will see the opportunity, when you review this carefully and compare it with the idea you have about the past bad Pyramid sales system.

Therefore, let’s restart our talks, with a nice bottle of red, after you have done your review on how this activity with Jeunesse could develop to be the missing column of your holistic Health and Wellness concept, and becoming a great opportunity to add value to your existing activity.

Well, it took me another few weeks, due to other commitments, until I really started to review seriously “Direct Sales and Network Marketing activities” – It was a shocking eye-opener! My information status on direct sales was outdated, like shown in the cartoon and frankly speaking “just wrong”! 

During this review, I also came across various video´s from Tony Robbins like “The power of influence” and as mentioned before, I saw Eric Worre´s video “The rise of the entrepreneur”, and got a detailed analysis of the today’s market environment, which I somehow, in the back of my mind, knew, but never brought together with an alternative sales philosophy, the Network Marketing!  When he mentioned Jim Rohn, who I used to listen to develop my skills and philosophy of life, I suddenly remembered that Jim Rohn also was associated with the success of Herbalife … a network marketing company!

I realized quickly, that I had to change my idea of network marketing being a sales scam and a pyramid scheme and started to review the activity of Jeunesse seriously and eventually decided to take it on as a distributor. I signed up with my friend, excused myself of being so ignorant, and purchased the Ambassador package to trying out some of the products first, before moving into the direction of a real distributor.  

Well, it was obviously not love at first sight, due to my misconception of network marketing, but now I admit,  I fell in love with the concept of Jeunesse and their cosmetic, health and wellness products and have started to develop a first small  own distributor network in the frame of my holistic stem cell treatment concept.

Jeunesse is not the same old story of skin care and supplements and certainly are not the same old network model. Jeunesse is a global business that helps people reach their full potential in youthful looks, in healthy living, in embracing life.

Jeunesse combines breakthrough sciences in a product system that enhances youth by working at the cellular level. By focusing on the health, longevity, and renewal of cells, we help people enjoy vibrant, youthful results that last.

Jeunesse Portfolio 2015 Falk

The people I consult with, come to me for the 21st century cell treatment as a prevention and health maintenance and the philosophy of health and beauty from “The inside out and the outside in” also as part of Jeunesse “Youth Enhancement System” is really an added technological value, but also quickly showed the financial opportunity Jeunesse is providing.

Helping people to stay longer healthy, looking young, get the body of their dreams with Jeunesse latest Fat Management Portfolio “ZEN BODI” and a fun way to develop financial freedom could not be a more fulfilling way to make a living and enjoy life with Jeunesse and its award system.

Therefore, when asked today what are you doing? I am not only mention

“I am an entrepreneurial cell and wellness consultant,
helping people in their health maintenance
to become and stay fit while aging”

but added an important part, which makes the activity so much more attractive with the words:

“and in becoming financially free”.

Well, shortly into my network marketing venture, there was in October 2015 the meeting in Paris, called Jeunesse University, informing and training new and interested distributors about Jeunesse, its concept and opportunity. The two days had been a further high motivator, to be involved in this activity after learning more detailed what the company has achieved with their science based products and marketing concept in such a short period of time.

Becoming the first company to achieve a global sales of 1.1 billion US dollars in a never seen before record time of 6 years, showing not only the quality and result driven product portfolio but also the strong management and distributor team concept, which has only one way to go ……. conquer the next billion in revenue and give many entrepreneurial minded distributors the financial freedom they are dreaming about!.

Meeting other people aligned with the company, talking with equally minded, developing own excellent health, quality life time and financial freedom, and helping others to experience this too is so exciting and motivating that I made the decision in October 2015 to become a real professional in Network Marketing, by not only integrating Jeunesse fully into my holistic health and wellness concept as shown before, but developing it as a stand-alone business, even it may take a year or so!

Realizing the opportunity on hand, but also knowing that you cannot achieve something by “Daydreaming” I decided to review what I am missing to become also successful in this field.

I started to learn and to followed the advice of successful people in this field and committed to stick it out through any discomfort that may come with learning something new.

Beside my favourite coach Jim Rohn, I started to followed and learn from Tony Robbins, Eric Worre, Bob Proctor but also from experts like Tanya Aliza to understanding better the why, they had been jumping on the network marketing bandwagon and how they became successful. Everybody has his own success story, and I am going to write my story too!

One thing I learned in my lifelong business activity is, associate yourself with successful people, in order to become successful. “Eric Worre’s GoPro” has become the de facto bible of network marketing and I can only highly recommend to anybody who starts network marketing to “GoPro” and learn from his wisdom.

I am not there yet, that large pay checks start to roll in, but already a few friends and business partners started graciously to praise me for helping them to reach their immediate health goals and showing them the additional financial opportunity, a clear sign I am on the right track. Network Marketing is not a tool to become rich overnight and by doing nothing. In “Network” the word “work” is embedded, and like everything in life which became successful there had been hard working individuals involved.

By making the commitment to be a professional and set clear realistic goals for an activity and myself, I have become successful for many years in corporate business. What I learned and applied in the last century, is a good basis and building block for new developments showing up on the visionary horizon. Therefore, today we have to start to apply the exponentially growing 21st century Know How, even though, being obviously in part still considered as experimental, like stem cells, PEMF Therapy and by some, even Network Marketing. However, after having learned and continually learning new skills, understanding concepts better, undoubted for me now too, the future of doing sustainable business in the health and wellness field had never been brighter for engaged individuals.

I also believe, an independent distributor, in a good network marketing company, will be more motivated than any company sales representative, as he not only will know the product best, due to own experience, but understand that his hard work, even after he retired, will be honoured, due to the retained earning structure of the team and customers he did build over time.

Everybody, however, needs to understand that success requires, time and dedication and there is no get rich quick scheme going on. The advantage of Network marketing is that you can start as a part time activity, with virtually no difficulty and heavy financial exposure like in a franchise. Your enrolment fee in Jeunesse is 25.00 Euros and then you can buy either single products or a distributor package to start as a home based retailer in one of the most attractive markets of the 21st century, the wellness and anti-aging market!

I have been involved in doing and starting business in many different countries and environment with the need and coverage of an extensive risk management, and I can confirm, there is really however no other business model out there that requires such a small investment in exchange for nearly unlimited earning potential.

Aristoloft, my own, also successful business adventure, is now also involved in my starting network marketing activity, building an own team of business minded entrepreneurs who like myself, realized that not only Jeunesse, but also other products like SBS with its PEMF portfolio is becoming an important science driven product portfolio helping to managing health while ageing in a stressful environment, providing the opportunity to improve the financial wellbeing, either as a supplement income or by creating even a whole new one.

Well, I hope I have helped you to understand network marketing better, as I do, after putting some effort in analysing and learning to understand Network marketing. I have realized, it fit´s beautifully into the 21st century of health and wellness treatments and the new age of lifestyle philosophy of a balanced work-life activity. Network marketing has the potential to enabling people to set their own business hours around family time and develop the confidence that their hard work and support in their network will result into a regular residual income, standard corporate activity does unfortunately not provide anymore.

My only regret is, not having taking this business model more seriously to build a team helping them to develop too, a stream of residual income,  much earlier,  even as a part time activity with my more than 35 year long trusted partner and wife Isabel.

Jim Rohn once said more or less along this lines, corporate wages will give you a living, profits from residual income will create the wealth you dream about. I should have followed him earlier in my life, but it´s never too late to become part of the few percent more lucky people, seeing and grabbing opportunities to improve their and their family lifestyle beyond imagination!

I do not like to sound, that I regret my corporate life, certainly not as it helped me to build my own foundation, or like to justify error´s and the (wrong) sceptical view on network marketing, but hopefully this review will help others not to make the same mistake in respect of direct sales activities, by even believing that Network Marketing is basically a women’s activity only, because obviously about 80 % involved in network marketing are women. Women are obviously more often meeting with their friends for a coffee and talk about their experience of everything and nothing, without realizing that this is the best background to develop a network marketing business. Avon and Tupperware tapped into this concept very successful and women who engaged into it became very successful.

Today, any entrepreneurial mind-set can enter network marketing and creating financial freedom. If you think this is something you may be interested in, but are still sceptical like I was, consider a few things:

Think about how often you have been “talking and sharing experience about service, cosmetic product, a holiday experience, accessories, cloths, shoes, cars, food, restaurants, bar´s, etc. you loved”. It is obvious, that the concept of sharing with a friend frequently what you like or dislike, is the natural way of expressing experience in life! Most of us are like this, because at our core we desire to help those around us, to share bad, but especially good experience, and expecting this “treat” also from our friends! This is activity is the basis of natural networking!

Well, just think about it, firstly, if you’ve ever recommended a great restaurant or movie to a friend, you do network marketing! Secondly, remember success in this business is only possible by helping others reach their goals. Well, women have a natural advantage as they are natural born nurturers and caregivers and Network Marketing / Direct Sales is an incredible way to unleash our gifts and abilities and get paid for using them, but what I have realized in the latest Jeunesse University meeting in Paris is, there are also quite a growing number of men there, — and even quite successful! So anybody able to share experience via good communication can enter Network Marketing, therefore you don’t need to have thousands of friends to be successful, you need to be a good communicator, focused and be clear about your goal involving yourself in game plans and events!

There are many good network companies out there with incredible products and support. Jeunesse is the fastest growing one with an outstanding product portfolio, repeatedly used every day, supporting and providing incentives for distributors and users at the highest level!

All it takes, is finding one activity you are passionate about, like I am with alternative health and wellness concepts, grabbing a few of your friends to run with you and committing to a common goal. Whether it takes a few months or a few years to reap your harvest, you will never regret financial freedom and the meaningful friendships you will potentially form in network marketing! Below is a video of Jim Rohn and his view on Network Marketing. Enjoy the idea of starting part-time!

Hope you will join my young, but at the same time very experienced team of health and wellness entrepreneurs to develop jointly your personal health maintenance and financial freedom and looking forward to your contact.

Falk
your trusted Network Marketer

Contact: falk.heinrichsohn@live.com (Personal)
falk.heinrichsohn@aristoloft.com (Company)

FB:  https://www.facebook.com/cellsurgicaltherapyaristoloft
https://www.facebook.com/IMRS.Health.Wellness.Sensation/
https://www.facebook.com/jeunesse.generation.young.mediterranean/
https://celltheraphyaristoloft.jeunesseglobal2.com/default.aspx

Other sources:

Network Marketing Pro – Eric Worre



https://www.youtube.com/watch?v=O2YvgGeJIHg

Tanya Aliza Official Blog – Home Page



https://www.youtube.com/watch?v=GakfEmYBukQ

 

 

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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.

Posted in Medical History and Future | Comments Off on Medicine in times of change!

Asthma vs. COPD

Asthma vs. COPD
Similar symptoms, different causes and treatment 

As many as 50 percent of older adults with obstructive airway disease have overlapping characteristics of Asthma and COPD. And this percentage increases as people get older.

Coughing, wheezing and shortness of breath are symptoms asthma sufferers are used to. They are also the symptoms of chronic obstructive pulmonary disease (COPD). For sufferers, as well as physicians, it can be difficult to tell the difference between the two conditions.

According to a presentation at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, as many as 50 percent of older adults with obstructive airway disease have overlapping characteristics of asthma and COPD. And this percentage increases as people get older.

Based on symptoms alone, it can be difficult to diagnose COPD vs. asthma. The pathway to a diagnosis of COPD or asthma — smoking vs. a long-term persistence of asthma — can be quite different,” said allergist William Busse, MD, ACAAI fellow and presenter.

In every patient, but in older patients in particular, we need to take a thorough history and perform a physical examination, as well as measurements of lung functions. In patients with COPD and asthma, the changes in lung function may be severe, and it is not often readily apparent, which is the predominant, underlying condition — asthma or COPD. Treatment will differ depending on diagnosis.”

Lung function changes in asthma are due to airway inflammation, and treatment is directed at reducing inflammation with corticosteroids — largely, inhaled corticosteroids. But the changes in lung function associated with COPD are caused by cigarette smoking and, except with an exacerbation, are not particularly responsive to corticosteroids.

The primary treatment in COPD is bronchodilators, including long-acting beta agonists. They help relax muscles around the airways in the lungs, allowing air to flow more freely,” said allergist Michael Foggs, MD, ACAAI president.

They should not be given alone to people with asthma. In COPD, but not asthma, inhaled corticosteroids have been associated with an increased risk for pneumonia and in some cases, features of both asthma and COPD exist. For these patients a combination of inhaled corticosteroids and long-acting beta agonists is usually best.

Some treatments for COPD and asthma are similar. Bronchodilators are used for both conditions. Other treatments tend to be more condition-specific. People with asthma are encouraged to avoid their personal triggers, like keeping pets out of the home or avoiding the outdoors when allergen concentrations are high. While people with COPD are also encouraged to avoid triggers, the emphasis in this condition is to stop smoking. Similarly, if a patient has asthma, smoking makes the underlying disease worse and reduces the response to inhaled corticosteroids.

Allergists who treat these conditions recognize that each patient, and their symptoms, must be treated according to their unique set of circumstances. People need to tell their allergists all their symptoms and complete medical history in order to receive the correct diagnosis and appropriately tailored therapy.

In our market review we have seen that some clinics are offering experimental stem cell treatments for COPD patients, in case traditional medication and its treatment is not anymore stabilizing or improving further Quality of Life of COPD patients.

There are mainly two experimental stem cell treatment options available:

1.   Stem cells from allogeneic (other person) or autologous (own) stem cells are developed in a Laboratory via clinical trials by certain health care providers. This is a treatment method where stem cells harvested from bone marrow, placenta, cord blood, peripheral blood, or adipose tissue, specifically treated and expanded in a lab and supplied after being approved by FDA / EMA to the market as “stem cell treatment in a bottle” ready to use via a Medical Doctor. In this case you may enroll in clinical trials for safety and efficacy studies before the product is approved.

2.  more recently in many international but also local clinics, autologous stem cells are harvested from adipose tissue (own fat) minimal manipulated and non-expanded used in the responsibility of a physician in a same day medical procedure to support unmet medical need in the frame of patient funded experimental medical studies.

There is much controversy going on in the world of stem cell therapy and COPD. Why? Autologous stem cell treatment without manipulation is legal, also in the United States, but some scientist claim that without manipulation, treatments are not likely to be clinically relevant. For stem cell treatments to be clinically relevant, millions of stem cells need to be implanted into a designated recipient. Because generating millions of stem cells is difficult once they are removed from the body, some scientists believe they must manipulate them somehow to produce larger quantities. The FDA says that manipulation turns them into prescription drugs, and that this practice must therefore be tightly regulated. Some scientist and Stem cell advocates don’t agree with the FDA’s stand on this, and are currently fighting to get this changed besides that, some scientists believe even minimal manipulated stem cell are treatment relevant as they increase quick and natural the potential of a body to heal itself.

We, in fairness to regulators, do acknowledge that some clinics may promote even not IRB approved medical treatment and here we fully agree that measures to protect patients have to be initiated.

Various international and local clinics with high quality standard, however, cannot be put in the same basket with those providing the famous “snake oil treatment”, although some people and bloggers enjoying doing it and with it confusing authorities and patients.

It appears furthermore, that there is sometimes a conflict of interest, even often disguised by scientists, when they are becoming inventors  and may be able to patent their product or method and with it, are financially rewarded by those marketing their product. There is nothing against those inventing something and getting rewarded. Authorities have, however,  to be open minded when regulating two quite different stem cell technologies. Both are stem cell treatments, alright, and undoubted have the capability to become disruptive technologies in the field of medical treatment, but one is using the philosophy of a drug, i.e. “Stem cells heavily manipulated in a bottle ready to use”  whereas the other is a medical procedure using  “Own stem cells very minimal manipulated in a surgical procedure”.  If a regulatory agency is placing both methods in the same regulatory basket it is reducing artificially competing  new quality treatment processes which cannot be neither in the interest of those paying for treatment nor for those in urgent need of medical treatment for unmet medical need.

A Stem cell harvested from one specific person, only minimal manipulated and returned to the same person in a same day surgical procedure is not causing any immunoreaction but improves the natural capability to increase its own specific healing mechanism as stem cells have the capability to home in, that means to go to places where the “own cell repair crews” are working and do ask for “natural assistance” of the body’s own cell structure.

For patients and patient advocates it is difficult to understand that the two very different technologies are regulated with the same regulatory tool. Asian countries have obviously already understood the difference and did already roll out the red carpet for the new technology with more easy approvement rules than Western Countries. They see it obviously already as a tool which could revolutionize the present treatment methods, benefiting quality of life of patients but also those paying for the treatment.

COPD Source:
American College of Allergy, Asthma and Immunology (ACAAI)
Stem cell treatment and Market Opinion.
http://copd.about.com/od/copdtreatment/a/Stem-Cell-Therapy.htm

Date:
November 7, 2014

Disclaimer:
All information provided in our web-side or BLOG is for educational purpose only and does not promote any pharmaceutical drug or medical treatment. For medical information on Asthma and COPD and its treatment please contact you trusted physician.

Posted in Stem Cell Therapy | Comments Off on Asthma vs. COPD

Wound Healing and Stem Cells

How real is
                Stem Cell Treatment for Chronic Wounds?

We are witnessing the change in medical treatment of the 21 century from treating symptoms with chemical and biological drugs to regeneration, potentially curing via most promising experimental Stem Cells, Gene, Bio-printing and Pulsed Electromagnetic Energy Technology.

Wound healing requires a coordinated interplay among cells, growth factors, and extracellular matrix proteins. Central to this process is the endogenous mesenchymal stem cell (MSC), which coordinates the repair response by recruiting other host cells and secreting growth factors and matrix proteins.

Unlike pharmaceutical treatments, that deliver a single agent at a specific dose, Mesenchymal stem cells (MSCs) are site regulated and secrete bioactive factors and signals at variable concentrations in response to local micro-environmental cues.

MSCs are self-renewing multipotent stem cells that can differentiate into various lineages of mesenchymal origin such as bone, cartilage, tendon, and fat. Significant progress has been made in understanding the biochemical and metabolic mechanisms and feedback associated with MSC response. In addition to multi-lineage differentiation capacity, MSCs regulate immune response and inflammation and possess powerful tissue protective and reparative mechanisms, making these cells attractive for treatment of different diseases.

The beneficial effect of exogenous MSCs on wound healing was observed in a variety of animal models and in reported clinical cases. Specifically, they have been successfully used to treat chronic wounds and stimulate stalled healing processes.

In our review we noticed that on 2. November 2014, 3228 clinical trials with the subject “Wound Healing” had been registered and 214, i.e. about 6.6 % are stem cell related trials.

Stem Cell - wound healing global map

The majority (93,4 %) of the 3228 clinical trials for wound healing is as mentioned before, based on traditional chemical and biological drug treatment, only 214 stem cell treatment had been recorded in the official government statistic on 2. Nov. 2014.

We need to understand that clinical trials for chemical and biological related drugs are taking ten (10) plus years and a lot of money by the investigating company before they reach the market. This, maybe is the main reasons that most clinical trials are still done in the traditional field of medicine, although 214 stem cell trials are showing a clear and high interest in new treatment methods.

Allogeneic Stem Cells and wound healing.

Allogeneic MSC treatments, had been categorized as a drug by regulatory agencies. This is a treatment method where third party stem cells from bone marrow, placenta, cord blood, peripheral blood, or adipose tissue is harvested, expanded in a lab and supplied after being approved by FDA / EMA via clinical trials, to the market as “stem cell treatment in a bottle” ready to use via a physician.

As mentioned above wound healing is a major research activity with 3228 registered clinical trials. 214, i.e. about 6.6 % are stem cell related trials.  Out of the 214 registered clinical trials, related to stem cell treatment; 39  (18,2 %) are with allogeneic stem cells. 29 trials are using bone marrow and 1 trial placenta derived stem cells some of them also combine manipulated genes with those harvested stem cells.

Autologous Stem Cells and wound healing

This is a treatment method where own stem cells harvested from bone marrow, placenta, cord blood, peripheral blood, or adipose tissue. This kind of stem cells if expanded in a lab, i.e. more than minimal manipulated, can only be used in human treatments after being approved by FDA / EMA via clinical trials, to the market as “stem cell treatment in a bottle” ready to use via a physician.

We found 83 (38,7 %) clinical trial of the 214 registered  trials are reviewing autologous stem cell treatments, countries involved see beside. Out of this 83 autologous stem cell trials, 5 are with adipose tissues.

From our market review we could see, that many international clinics already doing IRB approved or even non IRB approved (some non-western Countries) experimental studies not registered in the clinical trial statistic of the US government.

An IRB approved patient funded study is often done in well recognized international clinics with qualified physicians and clinical environment, following up experimental therapies in the frame of “Practice of Medicine and the Declaration of Helsinki”, i.e. the treatment is done as a “same day surgical procedure” in the responsibility of the surgeon not considered as a drug treatment.

The advantage of using autologous stem cells from adipose (fat) tissues and its stromal vascular fraction (SVF) is that it can easily be harvest via a mini liposuction. This mixture is minimal manipulated , non-expanded and re-injected via intravenous injections (IV) into the blood stream, or via direct injection, or by guided imaging  directly at the treatment site, for example in a chronic wound. All it takes is a 3 to 4 hour medical procedure in a qualified out-patient clinic set up.

This method is obviously more recently favoured by some treating physicians and even by patients, although it is experimental, as SVF from fat is rich in stem cells and contains about 500 times more stem cells than those same quantity harvested from a more painful bone marrow extraction. Furthermore there are various studies showing that the treatment with non-expanded own stem cells is safe, especially not having any immune reaction as they are deriving from the same body.s stem cells,

Link about safety of autologous stem cells:

 http://njms.rutgers.edu/gsbs/olc/stemcell2/2011/Oct%2019.pdf

Over the past decade, international research efforts have established a wealth of basic science and preclinical evidence regarding the differentiation potential and regenerative properties of freshly processed stromal vascular fraction.

The stage has been set for clinicians to translate stem cells from the bench to the bedside and certain clinics are key contributors to get this procedure out of the laboratories and to the patients who are looking for alternatives to their unmet medical need.

Woundhealing SC 2

Already in 2011, Bioheart, Inc., USA announced positive efficacy data from the registry study of bone marrow and adipose derived stem cells for the treatment of end stage critical limb ischemia with wounds. Vaclav Prochazka MD, PhD, MSc., of University Hospital Ostrava, Czech Republic presented data at the American Academy of Anti-Aging Medicine Conference in Las Vegas in Dec. 2010 The study focuses on end stage patients with severe wounds.

Endpoints include elimination of major amputation risk, ankle brachial index, toe pressure, transcutaneous oxygen pressure, and quality of life. Dr. Prochazka presented results of a clinical study with bone marrow derived cells and preliminary follow up of the adipose registry study. Seventy-five percent of patients presented with healing and pain reduction while only twenty-five percent of the patients required major limb amputation due to disease progression. Autologous adult bone marrow derived stem cells (BMSCs) and adipose tissue derived stem cells (ADSCs) can help to produce angiogenesis or formation of new blood vessels as well as assist in the healing process. There were no reported deaths or severe adverse events demonstrating the safety of the products.

In this connection we also like to mention that harvesting stem cells and growth factors from peripheral blood and using PRP for wound healing has produced amazing results.

Very clear “Hope for some treatments with stem cells, like wound healing is already Real” although stem cell treatment in general is still experimental.

Please note that we have to mention our legal statement that all those information provided  are for educational purpose only and those treatment results with stem cells are personalized from individual case studies only, not guaranteeing that the result can be always reproduced.

In case of doubts or questions please consult your trusted physician.

Sources:
http://stemcellstm.alphamedpress.org/content/1/2/142.abstract
http://omicsonline.org/adult-stem-cell-therapy-in-chronic-wound-healing-2157-7633.1000162.pdf
http://www.stemcellnetwork.ca/index.php?page=wound-healing&hl=eng

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The Future of Medicine

The Future of Medicine
          Shown in a successful clinical stem cell trial
                            for the treatment of tendon injuries in Australia

In one of the former blogs I have mentioned that medical development in the 21 century will be disruptive to the present treatment method and patients will see each time more the development of real personalized medicine.

One of my favourite Scientist and futurist Professor Dr. Micho Kaku talked on the occasion of a workshop at the University of Rhode Island’s 15th Annual Diversity Week in 2011 about the future of medicine. The video is a very interesting summery not only of the past, present and future of medical activities, but also a reflection of the future innovative environment humans will encounter, therefore I like to show it on my BLOG as his views in respect of the direction of medicine are each time more confirmed. Enjoy the YouTube video

and read below the news on the latest stem cell treatment in Australia.

As an example of the rapid development in stem cell treatment I like to draw attention to an unprecedented and successful clinical trial, announced on the 2nd of October 2013, for the treatment of tendon injuries using its patented stem cell technology in Australia by the  Regenerative Medicine Company, Orthocell Limited, Perth.

“World-first successful trial for tendon repair using tendon stem cells”

Tendon injuries are one of the most common causes of occupational and sporting disability and current clinical treatments are only moderately effective.

Orthocell’s new technique is known as Autologous Tenocyte Implantation (Ortho-ATIT) and involves biopsy of the patient’s own healthy tendon, isolation and cultivation of tendon stem cells from the biopsy in a special laboratory and then injection of these cells back to the injured tendon. The process takes about 20-minutes and is less invasive than surgery.

The company has received international profiling and recognition in the prestigious American Journal of Sports Medicine (AJSM), with a peer reviewed publication of the world first study on Ortho-ATIT stem cell technology for regeneration of damaged human tendon.

The AJSM, which is ranked as the world’s number one journal for orthopaedics and sports medicine, published outcomes of the clinical trial last week. The data demonstrates that Orthocell’s novel technology for repairing tendons was a safe and effective procedure that enables a reduction in pain and repairs tendon in severe chronic resistant tendon injury, like tennis elbow. The patients treated in the study, had failed at least one previous therapy including physiotherapy and corticosteroid injection. Patients achieved significant improvement in function and structural integrity of the tendon after the Ortho-ATIT tendon stem cell injection.

Orthocell Managing Director Paul Anderson said the clinical study indicates great potential for the Ortho-ATIT stem cell tendon repair.

“The AJSM paper is a benchmark study that validates the repair of tendon using tendon derived stem cells. We are now focusing our efforts on offering this world class treatment more widely to patients throughout Australasia, and we are also investigating new potential markets overseas,” said Mr Anderson.

The technique was the result of more than 10 years development by Professor Ming Hao Zheng’s group at the Centre for Translational Orthopaedic Research at the University of Western Australia, one of the top one hundred universities in the World.

“This is a very exciting body of work, which is indicated for a large patient population. There are currently limited treatment options for people suffering from tendon injury and related disorders, as there are no targeted drug therapies and surgery often delivers unsatisfactory results. This published study of Ortho-ATIT strongly suggested that substitution of tendon stem cells enables regeneration of tendon,” said Professor Zheng.

Amanda Redwood, a 45-year-old mother of two who participated in the trial, said Orthocell’s treatment relieved her of severe elbow pain within 6 months.

“I experienced debilitating symptoms of tennis elbow for more than 16-months before I had the procedure. Within 6 weeks of the injection the pain started to subside, and within 6 months it was gone,” said Ms Redwood.

“As a result of this condition I was unable to play tennis and netball with my 2 girls and I could barely lift anything without severe pain, not even a glass of water. It made even the most menial of tasks difficult, so I am delighted that I’ve been able to make a full recovery so quickly, without surgery.”

Ortho-ATIT has been approved by the Therapeutics Goods Administration (TGA) in Australia. The technology is currently available to patients in Australasia who have failed conservative treatment. More information about treatment options can be obtained by contacting Orthocell directly or visiting the company website.

Source:
https://www.univercellmarket.com/@offers/news/view/4409/
Orthocell  – PERTH, Australia, Oct. 2, 2013 /NEWS.GNOM.ES/ —

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