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
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
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
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
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.
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
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
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
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.
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
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
even been discussing the following with.George Goss is like the human matrix
of information when it comes to the history of this treatment.