Clinical Trial for Stem Cells [Update]

A small study that received far less press than was merited last week concerned patients with advanced heart failure, in Ecuador, who were treated with stem cells derived from fetuses.

The study showed, 30 days after receiving the stem cells by injection into their hearts, patients improved an average of 41% in their hearts' pumping efficiency and the distance they could walk nonstop increased by 72% in a standard test widely used to assess heart patients. After 90 days, the heart-pumping improvements were sustained and patients further improved the distance they could walk in the standard test by an additional 16% compared to 30 days and doubled compared to baseline. The study is the first to use human fetal-derived stem cell therapy in patients with heart failure.

UPDATE: One of our more astute readers (smart enough to stay anonymous) writes:

Unhappy as I am to suggest this to the folks at my favorite blog, I think the piece on the stem cell trial for heart failure might not be quite what it seems. The text below comes from a different Institute for Regenerative Medicine press release. The tip off is that they provide their "stem cell treatment" for the "effects of aging": About the Institute for Regenerative Medicine Based in Barbados, the Institute for Regenerative Medicine (IRM) offers stem cell treatment to patients with conditions ranging from diabetes and heart disease to digestive diseases and nervous system disorders. Opened in September 2004, IRM is one of the first facilities in the world to offer human fetal-derived stem cell therapy. IRM medical professionals provide individually tailored treatments based on a patient's medical history and status, and will coordinate with a patient's physician to integrate treatment. IRM is dedicated to providing stem cell therapy for disease states resulting from tissue damage and/or the effects of aging. IRM's stem cell therapy is based on its novel research combined with findings from more than 30 years of clinical research and experience of the Institute for Problems of Cryobiology and Cryomedicine, as well as other research documented in the medical literature. Under the guidance of its scientific consulting board and chief scientists, IRM is committed to developing new stem cell technologies for the delivery of stem cell therapy for disease management. Source: http://www.pressreleases.be/script_UK/newsdetail.asp?nDays=m&ID=27064 The press release below, dating to several weeks ago, has the institute awaiting ethical approval in Barbados and adds that the alleged stem cells come from the Ukraine:

Speaking during a breakfast press conference at the recently reopened Barbados Hilton, Suskind noted that the stem cells being used in the local study would come from foetuses sourced in the Ukraine, and that these had undergone rigorous testing before they were approved for use. He added that at least two other countries were being looked at as possible sources of cells.

The procedure involves the injection of stem cells from foetuses between five and 12 weeks old into diseased heart cells, and research has found that the stem cells have the ability to rebuild the damaged tissue. The technology was first explored in the former Soviet Union in the 1970s, but a recent study done in Ecuador, which showed some positive and encouraging results, was the first one done where the cells were injected into a heart that was still beating. It is hoped that this type of surgery will become an alternative to organ transplant surgery.

Source: http://www.barbadosadvocate.com/NewViewNewsleft.cfm?Record=21739

I have no basis to doubt the data from Ecuador, but I'm afraid I do doubt the gents at the institute in Barbados. Thirty year-old technology from the Ukraine makes me nervous, as does the notion of "rigorous testing" of biologics in Russia :) A Twelve week-old foetus is also relatively elderly if you're interested in stem cells, no?

While Professor Kass and his colleagues have been drinking tea and killing trees, various and sundry have set themselves up in business peddling "stem cells" for everything under the sun, but nearly always beginning with "anti-aging". Some of these businesses are plain old health fraud scams that offer cures for incurable diseases side by side with dietary supplements and laetrile. Others specialize in "treating" kids with autism by dosing them with umbilical stem cells.

MEDRA's web site is typical:
http://www.medra.com/index.htm

Dr Rader is a California psychiatrist, if memory serves. Another Californian is David Steenblock, DO. I leave you to draw your own conclusions from this media piece:
http://abclocal.go.com/wabc/news/wabc_052005_stemcellfamily.html

In 2003 FDA Office of Criminal Investigations shut down an osteopath in Atlanta who was conducting a bogus "study" on people with ALS - at $24,000 per injection. He caught FDA's attention when he didn't obtain his unlicensed biologic from a company with a clue about handling such products. Nasty stuff.

Dr Steve Barrett has a good article about these businesses on Quackwatch:
http://www.quackwatch.org/06ResearchProjects/stemcell.html

Perhaps I'm wrong, and jumped to conclusions ... The proliferation of these cranks is one of the consequences of substituting ideology for science and regulation. Looking at the education, training, and facilities of many practitioners and their so-called clinics and institutes, these folks might be peddling adventitious organisms with their cures.

Any way, just my two cents to take or toss.