Replies to post #2122 on AmStem Corporation (fka AMST)

[EZ2]

Now "that" is "breakthrough" !!

[MinnieM]

Nice find seeing it make the news in Singapore. ;)

It will be interesting to see when it actually hits market.

[ChartPoP]

HHHMMMMM! txs

[SMaturin]

Also from that PR:

Dr Shelly A Friedman of the Scottsdale Institute for Cosmetic Dermatology, who has been approved as principal investigator of this pilot study, said, “I am looking forward to conducting the initial clinical study of SteMixx. Since the consumer study showed such positive responses from women after only one month of use, I have wanted to see for myself how well this product works in a longer clinical controlled environment.”
...
The primary goals of the clinical study of SteMixx are:
• To validate the statistical design of the study
• To evaluate the experiences of women who use SteMixx
The results of the primary goals will be confirmed through evaluation of study photographs by qualified, independent dermatologists.

http://www.biospectrumasia.com/content/220910OTH13991.asp

I would like to see more details of the study protocol.

Dr. Friedman's quote "clinical controlled environment" does not explain what type of study this is and is rather ambigous, if not intentionally misleading.

"Initial clinical study" makes it sound like a pilot trial, to gather information in preparation for planning a more rigorous experimental design of a controlled trial (see my post yesterday). If so, it is not a "controlled trial" in the usual sense of placebo-controls or randomized design, where patients get randomly assigned to the new treatment versus an old standard treatment or a placebo. This is the gold standard for proving efficacy in medical treatments, which the FDA requires to approve new drugs.

The idea of "evaluation of study photographs by qualified, independent dermatologists" is not truly a controlled condition if the patient receiving the treatment and the doctor taking the photographs are not blinded to whether they got active treatment or placebo. The opportunity for bias to creep into one's actions still exists. However, having independent evaluators "blind" to the treatment condition, or whether the photograph is pre- or post-treatment, is a step in the right direction toward a rigorous experimental design.

I would also like more information about who the "independent IRB" is. The Scottsdale Institute for Cosmetic Dermatology is not a research or academic-affiliated institution, as far as I can tell from the slick website (http://www.scottsdaleinstitute.net/). It is a for-profit clinic run by Dr. Friedman. That does not disqualify the clinic or Dr. Friedman from doing good scientific research, but to get such research published in a reputable dermatology journal, he will have to disclose his financial relationship to AmStem, his academic affiliation, if any, and exactly who or what the IRB is that he claims has approved his research.

Women who are paying handsomely for cosmetic medical treatments do not want to pay to be experimented upon. Thus, I doubt this is truly a controlled trial, which is typically very expensive to run, and the care is provided free of charge to patients as part of the benefit of participating in research. Unless AmStem is funding this study to be a rigorous controlled trial intended to get published or presented to the FDA, the likelihood is near zero that it would be considered a scientific study by the medical establishment.

Full disclosure, please. Otherwise, this is all PR fluff.