ICMS Offshore guide is far more practical than the ISSCR's idea of world regulation


Pioneer Founding member
I was asked my opinion of the ICMS offshore guide to stem cell therapy vs. what the ISSCR is doing. Hands down, no doubt about it, the ICMS guide wins as far as helping patients right now in their decision making as far as I am concerned. We should have the new guide available the first of the week. Feel free to make your own comments on this blog.


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 non-profit group that claims a membership of 224 physicians and researchers from 21 countries, today unveiled a survey 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. While 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 co-founder 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 similar services online, according to Douglas Sipp, manager of science communications and international affairs 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.?

The ICMS has also 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 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 funding.

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 Denver, Colorado has received accreditation. The ICMS plans to include US-based clinics in its next survey.

Weighing the evidence

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, co-founder of Stem Cell Pioneers, an online patient-moderated forum for discussing stem cell therapies.

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 procedure.

?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 last month 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).

Mixed response

The ICMS survey is being met with a mixed response from the stem cell community. The ICMS is ?not just an organization created to hype this entire field,? says Bernard Siegel, executive director of the Florida-based nonprofit group Genetics Policy Institute. Siegel says that past reports from the society have offered an objective view: ?They?re actually trying to at least look at these clinics and offer a perspective.?

Sipp maintains, however, that the culture conditions used for most adult stem cell therapies offered both in the US and elsewhere violate the FDA?s requirement that human cells are minimally manipulated.

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 demonstrate government and institutional review board approval ahead of commercialization.

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.

Posted by Elie Dolgin on April 2, 2010 11:35 AM |


New member
FDA interferance

How or what can the FDA do to the medical people treating their patients with activaterd stem cells from the patient's own body? Why doesn't the
AMA step in and tell the FDA to get out of their business or the practice of their members. Who can give me an answer for my questions?


Pioneer Founding member
The ICMS is challenging the FDA's position. They have over 200 doctor members at this time. If you know of any doctors who would like to join, please give them the website information. The AMA is probably not the type of physician organization that would support stem cell therapy. Their numbers are fairly low in the overall scheme of things and many of their members are not in private practice.
Having been in a manufacturing business that the FDA had requirements for, I can assure you that they can and do make life miserable if they want to even if they have no regulatory powers over what you are doing. In the case of stem cell therapy, the FDA claims they do have an interest, whereas doctors who treat with stem cells in this country say they do not, that stem cell therapy is the practice of medicine and decisions for treatment should remain between doctor and patient.