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The Greek Study

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There is  a greek study that was released in 03/11 about the long term results of stem cells.

The link to the article is here

http://neurology.jwatch.org/cgi/content/full/2011/321/1

 http://www.webmd.com/multiple-sclerosis/news/20110321/stem-cell-transplants-may-treat-aggressive-ms

Believe me plenty people have emailed me about this as it is the latest article on the treatment. This will undoubtedly be used to answer the "Carmel Turner" question that neurologist have been
pestered with in the last few months. So I do feel the need to place the report into its correct context. As there is very little in the actual news paper articles that puts the study into proper perspective. I have even been discussing the following with my new friend George Goss in the US who is like the human matrix of information when it comes to the history of this treatment.
 


The 7:30 report on Ben Leahy the first person who successfully received Stem Cell treatment using the BEAM protocol, bens father quotes this study. This is due to the "Greek study" being one the first studies into using Autologous haematopoietic Adult Stem Cell Transplant to treat people with MS. This study occurred 15 years ago and PROCEEDED ALL OF the Phase I and Phase II studies the US HALT/MIST. The treatment cited in the article was not the same as the US trials, the treatment I, Ben, Che or Michael had.

Due to the extreme classification of the treatment at the infancy of the treatment that has gone through considerable change since. It was decided to treat people with the most seriously debilitating form of MS as a priority. Except for one patient, all had a progressive form of the disease and all of the patients were in the range of EDSS 6.0 to 8.0 (meaning that no one could walk without assistance, or were bound to a wheelchair, or even stand). It made sense to the researchers at that time to treat the most seriously-afflicted people. With what they considered an extreme treatment that was still in its infancy of development as a last ditch effort to save them.

A unexpected anomaly in the study  changed the way the researchers looked at HSCT to treat MS and subsequently changed the course of treatment with the selection criteria in both HALT and MIST studies changed as a result of this study. Out of the original treatment population there was a single person that had a high EDSS score, but was also diagnosed with RRMS with progressive disability.

This one patient had the most miraculous and positive recovery following HSCT. That clearly pointed the later Phase I researchers in the US to realize that people treated earlier responded substantially better with the curative effects of HSCT. If people were treated when the disease was at the latter stage of secondary progressive MS and it's monstrous effect fully realized for an extended period of time (5 years +), responded to the treatment at a significantly reduced also the longevity of the result of stopping progression was impacted. So the phase II trials in the US all focused on the relapsing remitting form of the disease and those who are at the early stage of secondary progressive (SPMS with relapses) in which people were not yet so severely disabled that they were permanently in a wheel chair and could not walk even a few steps or even stand. The two US trials require people to have a MS score of 2.0-6.0. The Phase II trials have clearly shown that people should be treated earlier in the disease cycle, and not at the later stages of secondary progressive because, put simply it worked......so with the Greek study they learnt a huge significant amount of information from that they still benefit to this day. They continue to track it and is report on it regularly as it still adds value due to the failure of the trial not the success.

On my home page of my web site I have tried (and maybe unsuccessfully, I am still polishing this off) to relate pretty much this. Researchers have discovered the success rate is significantly lower rate at right at the beginning of the disease, it then rapidly inclines to 81% success then rapidly declines again to 30% (I estimated these figures based of memory and experience and are not provided by DR Andrews) and now we can say this goes down to 25% considering the latest information. This narrow window of success was not only decided upon for the percentage of patients that respond to treatment but the longevity of the result.

And here we are again people at this window that I keep shouting from the roof tops. No one told me that there is a narrow window of success. What is my neurologist doing in regards to this narrow window for my treatment. Have I missed my boat?

To me this is the most concerning passage, Two people (six percent) died from complications related to the transplant at two months and 2-1/2 years post-transplant.

Some have said in emails, "but you said the death rate was 1%" what about this.....well like I said this treatment is significantly different to the treatment today and the treatment that I received but I am in no doubt I benefited from this study. The treatment 15 years ago did have a fatality rate of up to 15%. This has not been the case for a very long time people.

Some people in the early studies did die as a result of this treatment. But that is because in the "Greek study" and also the phase I US studies used Total Body Irradiation (TBI) in addition to chemotherapy. The result was intended to kill the bone marrow + immune cells wihtout doubt. When subsequent Italian and phase II trials removed inclusion of TBI therapy. It was observed not only did its removal did not impact the curative effect but the TBI-related effects that killed the people significantly significantly impacted the fatality rate of the treatment.

The current US trials with their evolved chemical-only protocols that were based off lessons learned from the Italian Milan studies and the Greek study. TBI is no longer used because it is now understood that TBI offers no additional clinical benefit, just added additional unnecessary risk to the treatment protocol. So since TBI is no longer used, guess what. . . . no more treatment-related deaths. Not a single one anywhere as part of any of the Phase II trials for this treatment given to people with MS. The first Phase II study occurred 10 years ago. That is a extended period of success that cannot be ignored except by neurologist.

That is not say though that the treatment (which is used for up to 15 different disease's in Australian hospitals most notably Lymph node cancer) has a 0% fatality rate. The treatment fatality rate is now 0.8% across Oncology departments in Australian hospitals for diseases currently treated that does not include MS. This lowering of the fatality rate has been achieved through experience gained in applying the treatment on a daily basis for over 15 years. This is mostly around the enforcement of procedures maintaining isolation and elimination of components of the treatment that were later observed to offer no benefit such as TBI. Also establishing chemo regimes that can be used in confidence for the mobilization part of treatment.

For MS sufferers the Lessons from this study and also the Phase I trials was don’t use TBI and treat people when they are earlier in the disease cycle. The US trials believe in doing so means that 100% of RRMS and secondary progressive that still experience relapses have their disease “stopped” and 80% have their disease “reversed” or "improved." This does not include Dr collins as he is focusing his treatment on a narrow window.

Now I get my turn to place a link and quote passages from the latest research, that will also place the greek study in its correct context.

Scientists Reverse Early MS With Patients' Own Stem Cells
http://www.medicalnewstoday.com/articles/137238.php

After an average follow-up of three years after receiving their transplants (which took place between January 2003 and February 2005), 17 patients (81 per cent) improved by at least one point on a [EDSS] disability scale. And for all [100%] patients, the disease had stopped
progressing.

The Greek study author Vasilios Kimiskidis, however, cautioned that more research was needed on the treatment.

Indeed. Since this study was completed a long time ago, there have been several phase II studies and now a phase III study in Chicago is in full-swing.

http://clinicaltrials.gov/ct2/show/NCT00273364?term=burt+and+multiple+sclerosis&rank=2

When this trial comes to an end the treatment will be covered under US health insurance and anyone in the US will be able to gain access to the treatment. How far can Australia be behind people! When are we going to have a phase III trial!

Some might say wait for the yanks as do Neurologist and the MS Australia. Both  point to this trial and state wait until the results are known.

This though is part of the problem people. This mentality is holding this treatment up from general release here in Australia. Until the trials complete in the US it not convered by US health insurance. The trials are self funded i.e the patient's pay all costs. This treatment is not what the X-cell center performs it is a very intense and lengthy procedure (and unlike the X-Cell treatment the US trials are repeatable and are peered review). The US patients have to absorb all hospital costs along with their doctors Mercedes payments. Not only do patients have to meet the entry criteria they have to rock up with $204,000.00 USD cash up front before they are excepted. They also have to pay up to $10,000 in costs for MRI's and accommodation just to be considered. How many are rejected from the trail based off the legitimate selection criteria and then told to hit the pavement if they don't have the cash. How many spend the 10k just to be told the dont even meet the entry criteria.

Considering the economic situation in the US, more people are denied treatment than anytime over the last 15 years due to lack of funds. It has taken 15 years to get to this point and it will take another 25 years for this double blind trial to come to and end due to these constraints. This is where Australia with it's wonderful Medicare system, can easily over take the Americans and lead the phase III trials to market in breath taking speed.

Further quotes from the original study "This is not a therapy for the general population of people with MS but should be reserved for aggressive cases that are still in the inflammatory phase of the disease,"

Now this is what I have an issue with considering current fatality rates are less than 1%. The treatment protocol is now so much safer that I think they should open HSCT to a larger percentage of the MS population. My own opinion is that this treatment should be made available to any MS patient that has had the full procedure and what it entails (how intense the procedure is) and confirmed they are healthy enough to endure the procedure. They have had the success rates for their particular stage of MS explained to them so they have a realistic expectation of the outcome of the procedure and the longevity of the result. The patient should take the decision not the doctor. If the shoe was on the other foot, studies have shown that doctors would
often defy their own treatment advice.

http://www.bbc.co.uk/news/health-13036508


I am fighting to make this treatment accessible to all if they wish. MS is an individual disease and individuals have a right to choose quality of life over a nursing home. I am a scientist and know scientific research and facts are proven even with failed studies that they continue to report on as they still add value but not a conclusion.

Doctors at time focus on a fatality rate of this treatment. They believe that occurs when the patient stopped breathing rather than when that patient had lost their quality of life to such an extent that they look forward to the death that their doctor prided themselves on avoiding. They look forward to conclusion as their doctor had offered no alternative through a lack of treatment or even hope of one. This is particularly sad when these treatments were first used in 1975 with HiCy and 1995 for Beam.

I Also would like to thank George Goss in the US who I have even been discussing the following with.George Goss is like the human matrix of information when it comes to the history of this treatment. 

Thank you George

http://themscure.blogspot.com/
 

 

      


 

 




 

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