Nature article on ICMS


Pioneer Founding member
This is an interesting article. The advice I was given by an ISSCR member in response to one of my postings on a blog was to stay in the U.S. for treatment or get into a clinical. As most patients know, there are no stem cell based treatments available for most diseases and there are no clinical studies either in the U.S. The ISSCR does not attempt to understand that there are time limitations for many of us. While they wait for Big Pharma to figure out how to control the use of our own stem cells, many of us will die. That is why patients go offshore for treatment. I long ago gave up any delusions that the U.S. and the FDA had any type of superior handle on ways to treat disease or cure it. Too much corruption has taken place within the FDA. Too many debacles.
The public is also well aware of the influence of Big Pharma in this country. Politicians are controlled by it. The media is and so too is the FDA. Doug Sipp, you may recognize from the Snake Oil program that Sixty Minutes aired a few weeks ago. How can we trust him? I believe he is paid by the ISSCR so I would have to say he has a financial interest for sure.
There is no easy answer to what is going on, but until patients are kept under house arrest, they will continue to seek treatment offshore. It would be in the best interests of everyone who claims to really care, that they should have access to information to make sure treatments are safe. I therefore support ICMS and its clinical registry because it offers a way for patients to be able to evaluate if a clinic is safe and working towards evaluating treatments or simply wanting to treat patients and do no follow up. Patients can put pressure on clinics to make sure they belong to ICMS. We have the power to do that and there really isn't anything the ISSCR, Doug Sipp, the FDA or any of the rest of those that wish to prolong denying us access to stem cell therapy can do about it. I am tired of their pseudo protection. Too many members on this forum have died and it wasn't from offshore stem cell therapy, it was from the lack of it in my opinion.

nature medicine volume 16 | number 5 | may 2010 495
Survey details stem cell clinics ahead of regulatory approval

A growing number of clinics offer unproven
and possibly unsafe stem cell treatments to
patients who are willing to travel thousands of
miles in pursuit of a cure. To help people make
more informed decisions, an international
society of stem cell clinicians has published
a preliminary survey of centers. But some
experts say the survey rates some therapies that
have not yet been approved and may ultimately
mislead desperate consumers.
The International Cellular Medicine Society
(ICMS), a nonprofit group that claims a
membership of 224 physicians and researchers
from 21 countries, unveiled a survey in April
offering details about 22 clinics that offer
adult stem cell therapies. The survey is based
on the clinics? voluntary responses to a series
of questions about the sophistication of their
protocols. Although the ICMS, formerly known
as the American Stem Cell Therapy Association,
is headquartered in Oregon, the report focused
on stem cell clinics based outside the US.
Medical professionals from the ICMS judged
the complexity of the clinics? cell processing
and implantation techniques and graded each
on a scale of one to three. ?The concept was
to compare the cost versus the complexity,?
says ICMS medical director and cofounder
Christopher Centeno. ?The intent was not
to evaluate other aspects of value, such as
outcome versus cost.?
The 22 clinics on the list purport to treat
more than 70 ailments ranging from diabetes
to Parkinson?s disease and span the globe
from Ukraine to El Salvador. A total of nearly
200 companies advertise services involving
unproven uses of stem cells online, according to
Douglas Sipp, who studies stem cell policy and
ethics at the RIKEN Center for Developmental
Biology in Kobe, Japan.
?The most important thing is to put the
information out there so that patients and
clinicians can look at it and make their own
conclusions,? says ICMS executive director
David Audley.
?We?re not making recommendations on any
one of these clinics,? Audley adds. ?This is just
the data that you as a consumer or a clinician
need to look at.?
In addition, the ICMS established a treatment
registry, currently with six of the 22 listed clinics
signed up, to track the health of people who
undergo stem cell therapies for up to 20 years
after treatment. This service?which aims to
provide independent oversight?is supported
by the patients, who each pay a flat fee of $350
in addition to the cost of treatment. Opting
out is not an option for patients at registered
clinics. The fee provides the bulk of the ICMS?s
The organization is also launching a certified
treatment registry for clinics that have been
fully accredited by the ICMS. Currently, only
Centeno?s clinic outside of Denver has received
accreditation. The ICMS plans to include
US-based clinics in its next survey.
Listed efforts
Independently, the International Society for
Stem Cell Research (ISSCR), which counts more
than 3,000 members, last year launched a task
force charged with creating a listing of asserted
stem cell therapies that are unsupported by
published scientific evidence. But patient
groups say they want more information about
working clinics.
?We need something right now, and we need
practical advice, and this is what the ICMS is
providing,? says Barbara Hanson, cofounder of
Stem Cell Pioneers, an online patient-moderated
forum for discussing stem cell therapies.
But Bernard Siegel, executive director of the
Florida-based nonprofit group Genetics Policy
Institute, says the ISSCR remains the best go-to
source for authoritative information, and he
urges would-be stem cell tourists to ?carefully
use due diligence, not only researching the
clinics, but the organizations purporting to
survey and grade the clinics.?
Regulation remains the major sticking point
between the two societies. In agreement with
the US Food and Drug Administration (FDA),
the ISSCR views adult stem cells as biological
drugs, whereas the ICMS sees transplanting
a patient?s own stem cells as a medical
?The [FDA] seems to be confused with what
is the practice of medicine and what?s biological
drug production,? says Centeno.
Centeno, a pain management physician,
reported in March that he injected more than
200 people with their own cultured bone
marrow stem cells to treat joint problems and
saw no tumors form at the reimplantation site
(Curr. Stem Cell Res. Ther. 5, 81?93, 2010).
Pros and cons
The ICMS survey is being met with a mixed
response from the stem cell community. Ralph
Dittman, a former surgeon and professor
at Baylor College of Medicine in Houston
welcomes the plurality of opinions. ?The more
information, the merrier,? he says. ?It doesn?t
hurt to get these other views if the consumer is
smart enough to discern what?s fact and what?s
But Walter Gardner, chief of the consumer
affairs branch of the FDA?s Center for Biologics
Evaluation and Research, maintains that most
adult stem cell therapies offered both in the US
and elsewhere violate the FDA?s requirement
that human cells are minimally processed and
are used for the same basic function in both
the donor and the recipient, even if those are
the same person. ?Many stem cell therapies
are not intended for a homologous use and
are more than minimally manipulated,? he
Sipp also worries that ICMS members might
be putting their own financial interests ahead of
those of patients by promoting some unproven
treatments. ?There?s a real risk that the ICMS
is trying to deregulate all of autologous stem
cell applications regardless of what the use is
going to be,? he says.
The ISSCR task force, which counts Sipp as
one of its members, plans to ask stem cell clinics
to provide peer-reviewed evidence of efficacy
and safety in animal studies and clinical trials,
as well as to demonstrate government and
institutional review board approval ahead of
That?s a high bench mark, says ISSCR
president-elect Elaine Fuchs of Rockefeller
University in New York?but one that is
necessary to protect vulnerable patients, she
stresses. ?We want to make it clear that many
of the therapies that are reported as being
fabulous cures for many different types of
disease are still in their infancy and not backed
up by the scientific evidence,? she says.
Elie Dolgin, New York

It is good that clients know that stem cell therapy is experimental and certainly unproven. When I see all of the possible side effects of the drugs for all manner of "illnesses" on TV and hear about the really serious side effects of some discontinued pain medication not to mention that most of the established medical treatments for cerebral palsy are barbaric and the drugs they use off label to treat people with are loaded with side effects, informed experimental stem cells from safe sources delivered effectively are a much better choice. Even the fury that simple hyperbaric oxygen therapy for cerebral palsy engenders from the mainstream medical/insurance establishment is sad.