Another telling article on X-Cell
I was sent this from a very reliable source. Much of what is stated here is exactly how I feel about this company. I would have to say Buyer Beware.
Translation of an article from WirtschaftsWoche, No. 16, 19.4.2010
The Hope Business11 diseases can be alleviated, XCell doctors believe, using their method 26 000 euros is the cost for Parkinson?s patients to have stem cells injected into their brains.
2900 treatments have been carried out already, XCell claims
Doctors want to cure heart disease and diabetes with stem cells. However,
companies are trying to lure in the seriously ill with exaggerated promises of
medical cures, before the benefits have been confirmed, jeopardizing human
life.
The pain returned during snowboarding - J?rn Bethge?s* right knee ruined his
holiday. Eight years previously, the 31-year-old?s knee cartilage was smoothed out in
an operation. Now, he?ll have to go back under the knife, says his orthopaedic
surgeon. However, he is also advising him to put the operation off, because this
procedure cannot be carried out over and over again. Otherwise the cartilage will run
out. Bethge had a better idea. In the internet he came across a new therapy which is
being offered in Duesseldorf, Germany. This therapy enables the torn cartilage to
regenerate itself with the help of stem cells. At least that is what is promised.
Making this truly incredible offer is the XCell-Center which has set up shop in the
Dominikus Hospital in Duesseldorf-Heerdt. Bethge made an appointment there and
also asked about the risks. He was told by one of the staff that the company has so
far carried out 2900 such treatments. And whether it was the knee, the heart or the
spinal cord, XCell?s stem cell therapy has never resulted in any complications.
The parents of a ten-year-old boy, who was recently admitted to the Duesseldorf
University Hospital, might want to tell a different story. XCell staff extracted stem cells
from the boy?s hip bone marrow and later implanted them into his brain. That was
supposed to alleviate his epilepsy and the resulting developmental disorders.
However, a few problems arose. The boy nearly died of a brain hemorrhage.
Although, the University Hospital doctors were able to save him, he is now even more
severely handicapped than before the XCell operation.
Footnote
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* Name has been changed.
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In answer to a question from German magazine, the WirtschaftsWoche, Stefan
Kempfen, a spokesman for XCell replied: ?I know of no complications arising from the
treatment.?
Stem cell therapies offer hope to millions of people with serious illnesses ? and quite
rightly so. One day, the therapy should be able to heal hearts damaged by heart
attack and cure cancer or diabetes. Stem cells, which can divide quickly and develop
into different types of cells, can be extracted and injected into parts of the body which
are diseased. There they can help to re-build new tissue as they do naturally during
the wound healing process.
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Researchers are concerned about the reputation of the new technology
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However, research into how the cells should be extracted and processed so that they
can develop their healing potential is only just now being conducted by scientists. In
strictly monitored, clinical studies on humans, researchers want to find out which
diseases can be cured by stem cells ? along with how the risks can be avoided.
Experts agree that even if they can create a stem cell therapy ?magic wand?, it will still
be years before the technology is available on a large scale.
Nevertheless, doctors and companies all over the world are trying to capitalize on
people?s hope for innovative therapies. They lure paraplegic patients, or those
suffering from heart disease or Alzheimer?s with medical cures which are still largely
unsubstantiated. They are not only jeopardizing human life, ?They are ruining the
reputation of one of the most important innovations in medicine?, says Wolfgang-
Michael Franz, a stem cell researcher from Munich.
Not every case ends as badly as that of the boy from Duesseldorf. Some XCell
patients actually consider themselves healed. Since autumn, the German
Neurological Society (Deutsche Gesellschaft f?r Neurologie or DGN) and the German
Parkinson?s Society (Deutsche Parkinson-Gesellschaft) have gone on the offensive
and issued warnings about the procedures which can cost from ?7,545 to ?26,000,
but are not covered by health insurance. ?Based on the current state of knowledge,
treating Parkinson?s patients with adult stem cells offers no benefit whatsoever?, says
Wolfgang Oertel, a DGN board member. Leading stem cell researchers have said
that ?Up until now there has been no scientific evidence that unprocessed bone
marrow stem cells will develop into nerve cells?. XCell creates this hope.
SCIENTISTS ARE ALARMED
Renowned researchers are no longer willing to just stand by and do nothing about
the situation. In the surrounding region of the two XCell sites of Cologne and
Duesseldorf, in particular, thirteen professors from the Stem Cell Network NRW
(Xcell sites in the city of Cologne and D?sseldorf fall within their catchment area)
have sounded the alarm. They are concerned that: ?XCell is offering stem cell-based
treatments commercially, for which there is no scientifically based evidence of
effectiveness?.
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wiwo.de: For further information on this issue (in German) see: wiwo.de/stammzellen
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The regional government of Duesseldorf also has the company ?on their radar?, says
Stefan Fiebig an instructor (Fachreferent) in this area. And this week, representatives
from the Stem Cell Network will be meeting with the local, regional and national
regulatory bodies ? the Paul Ehrlich Institute (PEI). Together with Klaus Cichutek, the
Head of PEI, they want to clarify to what extent patients should be protected against
these types of therapies.
What bothers the researchers is the fact that neither Cornelis Kleinbloesem, the
Dutch founder of XCell, nor any of the doctors working for Xcell, have attracted any
attention to date with publications on stem cells. ?We don?t know these people in the
way we know other stem cell researchers from conferences, for example, where you
can discuss developments or regulatory issues?, said Peter Wernet, a stem cell
researcher from Duesseldorf. In plain terms, hardly any outsiders know how work is
being carried out at XCell.
MIRACLE HEALERS FROM CHINA
This is the kind of thing you would expect from the more than 100 miracle healers in
China, India or Russia, to whom terminally ill patients have regularly pilgrimaged in
recent years. The late artist Joerg Immendorff was among those making such a
journey, travelling to China in 2004 to find a stem cell-based cure for his terminal
amyotrophic lateral sclerosis (a neurological disease), without success.
XCell has established itself in Cologne and Duesseldorf and is attracting similar
attention. That these cities are in the middle of Germany, a country which is
considered the world over to be especially strict when it comes to monitoring and
approving new technologies and therapies, is significant.
Xcell is playing the Germany card for all it?s worth. Emblazoned on the company?s
website is the blue and white badge of the world-famous German technical inspection
agency ? T?V. XCell has achieved their ISO 9001 certification. However, this does
not tell you anything about the quality of the therapy itself. It merely indicates that the
employees have attended training on how to operate the medical machines correctly.
But who will actually make this distinction?
Many of XCell?s clients come from foreign countries. When you enter the XCell
premises in Duesseldorf, which extend over one-and-a-half floors of the hospital, you
see people in wheelchairs, on crutches and you hear languages such as Russian,
Arabic ? and Dutch. An advisor proudly recounts that the company employs over 100
people worldwide. However, the treatments are carried out in Germany. They have
been ?certified and regulated in accordance with German law?, because that way, she
says, ?the patients feel at ease?.
For XCell, feeling at ease is of paramount importance. Dark, oiled, parquet flooring,
white corner seating units, pink tulips on a white table and a bright orange children?s
play area are a pleasant relief from the ?seventies? style of the other floors of the
Duesseldorf hospital.
XCell staff do almost anything in order to ensure that patients have a good and
secure feeling. Even if it means straying away from the facts. For instance: ?Are you
licensed??, asked a prospective patient from England in an e-mail which the
WirtschaftsWoche came across. The advisor answered in the affirmative. The
German government took ?a very close look at the safety aspects of the treatment?
before issuing them with a licence. However, the PEI only played a part in issuing a
permit for the extraction of stem cells, said Cichutek, the Head of PEI. The treatment
itself is currently not licensed.
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Pseudo-safety in a legal grey area
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In fact, approval for these therapies could not have been given since they have only
recently been legally regulated. Only in the future will new therapies have to be
approved centrally by the European Medicines Agency (EMEA). To date, such
therapies have been legal even without special approval. However, in order not to
torpedo all the promising applications of stem cell therapies and tissue culture
already on the market, the law is granting companies a transitional period (until 2012)
so that they can apply for approval. For special cases, a requirement to seek
approval from the Paul Ehrlich Institute by the end of 2010 has been introduced. This
could apply to XCell.
Gustav Steinhoff, a stem cell researcher from Rostock, is working on getting
regulatory approval. He tests therapies like the ones XCell is currently selling as
being safe and established. He, too, injects so-called adult stem cells which have
been extracted from patients? bone marrow. They are supposed to restore muscle
tissue in patients who have suffered heart attacks. Steinhoff wants to provide
evidence for the effectiveness of the stem cells. In 2009 he began a clinical study
with 150 patients who, by way of random distribution, are treated with or without stem
cells. He is going to apply to the EMEA for approval of the therapy on the basis of the
phase III study, although it will be a huge effort. Yet, the researcher is confident: ?This
is the only way to create a successful product which can be marketed globally.?
THE RISKS HAVE BEEN PLAYED DOWN
For precisely this reason, scientists like Steinhoff are annoyed with companies like
XCell. Not because their ideas are fundamentally wrong, but because it is far too
early to hold out the prospect of cures for serious, incurable, diseases such as
Parkinson?s, multiple sclerosis or paralysis, say the stem cell researchers with
academic backgrounds.
At the same time, XCell plays down the risks on its company website, such as the
risk of developing cancer. In clinical studies, like the one being carried out by
Steinhoff, stem cells, which divide quickly and can develop into different types of
cells, are monitored to see whether they can turn into tumour cells in the human
body. Although this risk is lower for adult stem cells from bone marrow than for those
from embryos, it cannot be ruled out say the experts. There has been at least one
case, which occurred in an Israeli hospital and has been documented in a specialist
journal, in which a 13 year-old boy developed a brain tumor after such a stem cell
transplantation.
In order to clarify what the opportunities and risks associated with XCell?s methods
are, Cichutek, the Head of PEI, would like to see controlled clinical studies of the
therapy. The company has indicated that it would like to begin clinical studies soon
on spinal cord injuries and brain damage. It is virtually impossible to judge the
seriousness of the intentions of the company?s leaders. XCell?s spokesman,
Kempfen, said ?The application to conduct the studies has been submitted, we are
just waiting for the definitive ?go? from the authorities.? PEI is not permitted to either
confirm or deny this.
Up until now, XCell has apparently not followed up even once to see if the therapy
has taken effect. If someone calls up and says that he or she is feeling better this is
included in the statistics, which, for example, show a 70% success rate in curing
brain damage in children. However, although the company promises a
comprehensive follow-up service, has not asked the patients for feedback, according
to those involved. XCell does not want to comment on this or on any other criticisms.
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Stem cell therapy can trigger cancer
UNSUCCESSFUL APPLICATIONS
Those who are familiar with the company?s history would, in any case, find it difficult
to believe that Kleinbloesem, the Head of XCell, really wants to conduct expensive
clinical studies with a team which is not well-known for its stem cell research ? or that
he would even be able to. According to research carried out by German radio
(Deutschlandfunk) he has already failed to get approval for corresponding
applications in Belgium and the Netherlands. The background: in his home country,
the Dutchman had already founded a company called Cells4Health. Its business
model was very similar to that of XCell. In the Netherlands, too, serious researchers
and doctors were up in arms. The government reacted and in 2006 it passed a law
restricting this type of stem cell therapy to academic facilities only.
Thus, Kleinbloesem could not carry on ? and he founded XCell in Germany, first in
Cologne and then in Duesseldorf. Now, he is building a further annex just a few
minutes walk from the hospital in Heerdt, which will be used for the purpose of
research and development of the therapy, according to XCell. Tests will finally be
carried out there, after thousands of patients have already been treated
commercially, to try to demonstrate the effectiveness of the therapies.
Scientists would usually do it the other way around.
susanne.kutter@wiwo.de, sebastian matthes
? Handelsblatt GmbH. Alle Rechte vorbehalten
This translation has been conducted by the Stem Cell Network NRW based on the
Article ?Gesch?ft Hoffnung?, Wirtschaftswoche, 19.4.2010.