REGULATIONS – The barriers of hope to heal yourself with stem cells………….

Stem Cells,

              the potential to heal yourself……..

While stem cell research and applied  science clearly advances exceedingly rapidly and first clinical trials confirm the envisioned improvements, authorities review advancements of potential cure of diseases with stem cell treatment in the 21st century with methods obviously correct for a drug developed to treat symptoms  in the last century.

As a result, stem cell treatment in Western countries is considered as experimental and, therefore,  in general not allowed,  except in specific and authorized clinical trials. These restrictions open up the door, to look for an alternative,  i.e. to stem cell therapy tourism

even to places  being neither well equipped nor and controlled, offering only hope of a cure for a lot of money.

Now as, Western authorities are (stubbornly)  building one barriers after another in the name of patients safety, patients desperate in need to improve their health just simply use alternatives which are offered in the 21 century environment in many different ways…...Therefore, these unjustified barriers are the real reason for stem cell tourism as advances in science are available at 24/365 terms to anybody who likes to know it but, unfortunately, also opens the door for fraud, and unjustified hope.

Authorities in Western countries would be better off in accepting this new treatment method under “experimental and clinical trial conditions in their countries and clinics”, so to advance with stem cell therapy. This would help to advance Know how quickly in this new science field and furthermore would provide direct control of advances and results of this experimental science.

A video by SammyJo Wilkinson, who talked at the Houston Stem Cell Summit, was published on 13 Jan 2013 where she explained the actual situation of stem cells in the US as follows:

I was on a panel of 4 patients, all treated with our own adult stem cells. Each of us had great restorative effects for serious ailments like multiple sclerosis, arthritis, or orthopaedic conditions. Now the FDA made an overzealous ruling our own stem cells are a drug, if expanded to reach a therapeutic dose. Now this therapy is no longer available in the US as of the start of 2013. So be cautious when evaluating clinics that offer a low-dose therapy for a serious condition like MS. For comparison, I received 600 million of my own adipose-derived autologous mesenchymal stem cells. The FDA is forcing patients into medical tourism to achieve effective therapy. But stay tuned, is a group of patients who are fighting for every sick person’s right to use their own stem cells for repair, restoration and recovery from grave illnesses, many of which have no other effective treatment.
SammyJo Wilkinson

There are obviously two main barriers for using stem cells as medicinal alternative:

1.    BARRIER:
Stem cells are considered by the FDA, but also by EMA  the equivalent organisation in Europe, as drugs, which means that once you have harvested and cryopreserved your own stem cells in a country they can only be used in accordance with the relevant regulations.

Own stem cells are considered to be drugs not been  approved by the FDA. Stem cell treatment furthermore is considered as experimental and substantially prohibited, except as part of an approved clinical trial procedure.

As stem cells are classified as biologics, they need to follow the stringed rules and regulations (FDA and CDC) for exporting respectively importing those materials. First it is difficult to get a licence as you have to fulfil a number of preconditions, secondly each import and export is registered in detail and approval is not automatic but very time consuming.

The FDA has published on 61 pages a guideline on the export of biologics covering also stem cells. Customs, in those countries where those FDA and / or EMA guidelines are applied, making the transport of human stem cells across international boarders quite a  complex task if to be done lawfully and ethically; — i.e. it is next to impossible to transfer your stem cells quickly to another country when needed urgently.

The problem with using own stem cells freely is mainly the definition of drugs intended for the pharmaceutical industry and defined by the FDA. According to  the Food, Drug, and Cosmetic Act, a drug is:

      • A substance recognized in an official pharmacopoeia or formulary
      • A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
      • A substance other than food intended to affect the structure or function of the body
      • A substance intended for use as a component of  medicine but not a device or a component, part, or accessory of a device.

This definition of a drug together with the export import licence requirement does not allow at present an easy use of stem cells in countries following the rules and regulation of the FAD and EMA.

A substance, which is not recognized, has to be recognized by the relevant authorities in order to be used.  On the other hand a substance intended for use in mitigation, cure, treatment, or prevention of diseases has to be registered via extensive clinical trials. That basically gives no room to use nor register easily adult stem cells as medicine / drug, as they are personalized, neither in the country where they are harvested nor in the countries where stem cell treatment as an experimental treatment is possible except they are minimally manipulated.

In January 2013,  the authorities have started to investigate a Korean stem cell company RNL Bio. RNL Bio is doing stem cell business in the US with it’s subsidiary Human Bio Star and RNL Biostar. The Korean Government leading this investigation is accusing RNL of having smuggled stem cells from Korea across the border in Japan and China.

Here are some links of press releases:

Another company, Celltex, US is accused to treat patients with non authorized medicine (drugs / stem cells) by the FDA  and Celltex has announced earlier this month (February 2013) to relocate it’s stem cell treatment for it’s patients to Mexico. As the stem cell samples, however, had been harvested in the US and stored at Human Biostar being also under investigation of smuggling stem cells across borders it remains to be seen how Celltex get’s it’s stored stem cells across the US border to Mexico without violating FDA export regulation………!!!

Well, it is also to believe that the interpretation of stem cells as drugs by the FDA and EMA will reduce the potential service of private stem cell banking as the utilization of own stem cells will be very much restricted, although science is advancing and shows interesting successes, via experimental, mainly overseas,  stem cell treatment.

It is evident and foremost to notice that harvesting stem cells in early life have clear advantages in respect of quality of stem cells then harvested in later periods of life as documented in one of our earlier blogs.  So, the question should be allowed: Why allowing harvesting stem cells at all at stem cell and bio banks from Cord blood, when  its usage is so much limited by regulation. Who actually benefits from this regulation? Patients, Payers or ….??

The crucial question our society has to answer is why is this so restrictive, even though there are cost advantages for NHI. The potential cost – benefit ratio is shown as an example in our diabetes post. Another question we have to ask is why are there still more, and growing institute related trials under way while the pharmaceutical industry carefully takes an observer seat.

As mentioned in an earlier post those countries who are more flexible in treating diseases where traditional 20ties century medicine cannot improve or maintain quality of life, will gain a competitive advantage in applied stem cell know how of the 21st century, while the West slides into a developing country status in this new applied science field.

It is in the interest of humans, but eventually also of payers, to advance quickly in respect of stem cell therapy which provides a chance of curing diseases.  This shall result in improved quality of life and less cost for those involved in paying for the healthcare service because curing is clearly cheaper than treating symptoms for the rest of the life of a patient.

We therefore are encouraging more investigator initiated clinical trials to show that not only, the concept of stem cell treatment is right,  but also the result in specific treated diseases with stem cells becomes a proof of it.    This will help to justify the “liberalisation of adult stem cell therapy as a substantial improvement of quality of life”, as an alternative to the traditional medical treatment of symptoms.

As mentioned before,  authorities in Western countries would be better off in accepting this new treatment method even under “experimental and clinical trial conditions” in their countries and clinics. This, in turn, would help to advance quickly with relevant applied stem cell Know how  and furthermore could provide direct control of advances and results of this new science field.

Stem cell treatments does offer already today enormous promise, and once these treatments have been developed further it may even revolutionize medicine as we know it. Therefore, let’s not discuss this endlessly with a chicken and egg philosophy, by asking: ”Which developed first, the treatment with stem cells or the stem cells for treatment and how do we regulate them”?

In the Oct. 17-2012  issue of ESPN The Magazine, appeared the following story regarding athletes  trying to prolong their career through stem cell treatments, eventually facing the same barriers as mentioned above.

For the past two decades as the Steelers orthopaedist, Bradley has listened to injured athletes beg him to be creative in getting them back onto the field. Jim Bradley understands the season-on-the-brink desperation that, according to Fox Sports, sent Peyton Manning and his ailing neck to Europe this summer, seeking the experimental promise of stem cells. “In the last year, I’ve seen half a dozen guys go to South Korea, Japan, Germany, even Russia for stem cell procedures,” says Bradley, a past president of the NFL Physician’s Society. “And there’s going to be plenty more.”

Clinics around the world report amazing results using these minimally invasive cellular procedures to repair torn  anterior cruciate ligament (ACLs), And that’s the problem: The most exciting action is happening overseas.

Thanks to a mix of politics, bureaucratic foot-dragging and scientific caution, American doctors are prohibited from culturing stem cells, let alone culturing them into stages as advanced as their foreign counterparts. Hence Manning’s trip abroad. Bradley, a former Penn State defensive back, doesn’t mince words. “We’re at least 10 years behind the rest of the world,” he says.

The 57-year-old doctor should know. In January 2009, after Hines Ward left the AFC championship game with a torn MCL, Bradley administered a form of platelet-rich plasma (PRP) therapy, a strange and novel procedure at the time. Placing a sample of Ward’s blood in a centrifuge, Bradley isolated the plasma and platelets, which contain natural repair engines, then re-injected the serum into the receiver’s injured knee. Ward returned to the field two weeks later for Super Bowl XLIII, a remarkable recovery he and Bradley credit to the procedure. Had the Steeler opted for rest and physical therapy instead, the two say Ward likely would have watched the big game from the sideline.

At the time, Bradley was hailed as a genius; weekend warriors everywhere started asking for the “Hines Ward treatment.” But compared with the latest stem cell technologies, PRP looks about as revolutionary as leeches. Instead of relying on the relatively small number of stem cells that swim in blood, cellular scientists elsewhere in the world are extracting millions more out of bone marrow and fat, than engineering them into injury-fighting miracle workers. In Europe, it is rumoured, healthy top-level soccer players are already having their stem cells harvested and grown into lines of bone and connective tissue in case of injury. “They’re doing it, so they’ll have a ligament line ready if they get a tear during the season,” Bradley says.

Much like the steroid scandals a decade ago, this stem cell gold rush is testing sports’ ethical boundaries — but this time the issue is about aiding recovery instead of enhancing performance. Antidoping authorities and federal regulators find themselves in uncharted territory, raising questions about whether our own blood can be considered a drug. In this new reality, the cutting edge is no longer just what jocks are putting into their bodies. It’s about what they’re putting back into their bodies.

Christopher Centeno, another pioneer in this field, unfortunately has paid the price for being on the front lines of this culture war. Until last year, Centeno was doing a booming business culturing mesenchymal stem cells at his Broomfield, Colo. Clinic, called Regenerative Sciences. When NFL defensive end Jarvis Green visited the doctor in 2010 after two failed knee surgeries, the player faced the end of an eight-year career with New England. Shortly after receiving his stem cell treatment, Green was back in the NFL. “Before, I couldn’t walk up the stairs,” he told The Mag. “Three weeks later, I went to an NFL training camp and didn’t miss a day.”

Green’s recovery gave him one more season, with Houston, before he retired. But he had one of the last seats on Centeno’s cultured stem cell miracle train. In August 2010, the U.S. Food and Drug Administration brought the hammer down on Regenerative Sciences, filing a federal injunction to prevent Centeno from culturing. The FDA claims he was “adulterating” blood in a way that turned it into an unapproved new drug, clearly indicating that the definition of “minimal manipulated” by the FDA is strictly enforced.

Centeno, who still provides same-day stem cell procedures, has spent $500,000 fighting the agency’s controversial opinion and even more money moving his culturing operation to a new clinic offshore in the Cayman Islands. “The FDA has pushed this therapy out of the U.S.,” he says.

A representative of the FDA declined to comment, saying only that U.S. policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues.”

Yankees starter Bartolo Colon was treated using those kinds of stem cells in March 2010, when he was still unsigned and struggling to throw 80 mph after Rotator cuff surgery. Orthopaedist Joseph Purita, who runs the Institute of Regenerative & Molecular Orthopaedics in Boca Raton, Fla., travelled to the Dominican Republic to perform the procedure at Colon’s request. There, Purita harvested marrow from the then 36-year-old pitcher’s pelvis and spun it in a high-speed centrifuge to procure a syringe full of thick, mesenchymal-rich serum. But instead of waiting weeks for those cells to multiply and grow as cultures, Purita stayed within FDA guidelines and injected Colon’s cells directly into his right shoulder and elbow. The process took about an hour.

Colon’s impressive start this season — he compiled a 64 record with a 3.20 ERA before the All-Star break — caught MLB’s attention, and league investigators asked for the records of his treatment, wondering whether something other than stem cells deserved credit in his recovery.

Again, rules and regulations of Western authorities have pushed the stem cell therapy out of the U.S. and Europe. Regenerative Science and stem cell therapy is a new science which

should be encouraged as much as possible by authorities and governments, like in Malaysia as an example, by providing an easy framework for relevant clinical stem cell trials which will help  confirming the advances in experimental science.

With this in turn  we quickly will get the proof of scientific advances from the bench to the bedside. Therefore, patients who are willing to volunteer, even to pay are the support of technological advances and should get a chance to be treated in their home countries, and as such avoiding potentially dangerous and expensive stem cell tourism.

As Western countries are claiming that they however have to be so restrictive in the name of patient safety, the most exciting action and advances are happening overseas.

By the way the FDA, just as an example, has long approved Knee replacement therapy  having a success rate of around 90,0 % and needs many months to be followed up by Pain management as an important part of the recovery process. There is no guarantee in this medical process nor for any kind of stem cell treatment because you have to sign a waiver reducing the responsibility of those operating. In the end what is the difference?

Stem cell therapy even appears to be faster, though  experimental  and unfortunately due to stem cell tourism not so well documented processes. Furthermore it appears to be less painful, as it is a natural curing process without using artificially screws and bolts to hold together what is broken like in a machine! Authorities have the duty, in the name humanity and patients, to give the new medical advances a better chance and support.

Chasing the miracle cure, by Shaun Assael, ESPN, The Magazine, October 5, 2011

International transport of human stem cells is a complex legal & ethical matter

Definition and More from the Free Merriam-Webster

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