They have also used suggestive language that they (or their apparently affiliated company Scharp Technologies) were collaborating with what is, in my opinion, one of the best research institutions in the world: Sanford-Burnham.
I have now got an official response from Sanford-Burnham regarding the company selling Stemáge stem cell anti-aging.
I heard from Deborah Robison, VP of Communications as follows:
“Sanford-Burnham is not collaborating with Stemage, has no relationship with the company, and has no involvement with the product or any commercial aspects. The verbiage on the Stemage website was not approved by Sanford-Burnham. Sanford-Burnham provides no endorsements with regard to commercial products.
Sanford-Burnham has a corporate sponsored research agreement with Sharp Technologies, Inc.; through the agreement Sharp Technologies provided stem cell material to the Institute and information regarding the biology of the stem cell activity is being shared with Sharp Technologies.”
I am attempting to find a way to contact Stemáge and Scharp Technologies for comment.
Occasionally I call out a particularly important comment by a reader on a major issue.
Today it is commenter Natalie DeWitt (see my earlier interview with her about her experiences at Nature’s The Niche) who has contributed a particularly insightful, knowledgable comment on my recent perspective piece the Cell cloning paper mishap.
Many in the stem cell field and beyond have been unsure how to take the news of the problems with the Mitalipov cloning paper in Cell.
Are these issues a big deal or not so much?
DeWitt provides some much needed historical context and wisdom for thinking about the Cell cloning paper mess:
“I am writing now as an individual– not affiliated through an affilitation with any organization. When I worked at Nature, we had to verify that Snuppy was indeed a cloned animal, after the fact, and after publication. This was done by very straightforward (if you save oocyte donor and nuclear donor tissue samples) genetic analysis. In an editorial I later wrote on this topic, I and my Nature editorial colleagues recommended that for critical cloning papers, since it’s so easy to verify, they should submit verification from a separate lab when they submit the paper. You can read the editorial here. http://www.nature.com/nature/journal/v439/n7074/full/439243a.htmlThis was recommended by thought leaders in the field, and through our own experience in verifying Nature cloning papers, namely dog and monkey cloning. Now it will be done on these Mitaliipov cell lines, for sure, but in the meantime, once again, there is unnecessary turmoil. Questions about bad science, bad editorial practices. A world class lab that has now contributed to another page in what is becoming a “what not to do” primer.Would have been better to submit the cells for independent analysis and submit along with the paper.With regard to short period of time of review– there is competition amongst journals for high profile papers and sometimes promises of very rapid turn around are made. I don’t know if that happened in this case, but as much as scientists complain about excessively lengthy peer review, I suspect in the end they would prefer that to the current situation. Which frankly, does not reflect well on any of us in the scientific community.”
Updated (May 23): note that preliminary word from Sanford-Burnham is that they are not collaborating on Stemáge.
I was alerted by a friend to the fact that there are now YouTube ads for stem cell products popping up.
One such ad features supermodel Kathy Ireland pitching for something called Stemáge Skin Care.
Today’s post is Part 1 of at least 2 on this Stemáge product.
I will post Part 2 soon that is a must read as it includes information my somewhat shocking phone conversation with a representative of the company regarding where they obtain the stem cells for Stemáge and more.
Why is a human stem cell-based cosmetic cream important?
Such a product can be considered a medical product subject to regulation by the FDA and the FDA also oversees the efficacy or safety claims made by sellers of such products. For example, in the past the FDA has sent a serious warning letter to L’Oreal/Lancome in the past (here). Such products also can potentially have health risks.
This Stemáge human stem cell-based cream claims to have anti-aging and other medically beneficial properties. It apparently contains human stem cell laboratory byproducts from other people’s stem cells that are to be used on your skin.
The prices range from about $50 up to around $130 per month. That’s a lot of money in today’s economy.
The company selling the product is Stemage Skin Care, LLC in Charlotte, NC.
Based on its description, in my opinion Stemáge might be a drug that should be evaluated by the FDA prior to any human use, but the company says in its FAQ section that no FDA approval is required. It also reports no side effects.
Is Stemáge a drug?
I don’t know, but it is certainly not your average skin cream that you can get at Walmart or order from QVC.
The Stemáge product is not just being pitched in YouTube ads, but also has its own YouTube videos featuring Ireland as well (see below).
One such video includes the following description as text:
The surgeon developed, adult, human stem cell derived full face and body skin rejuvenation system. Stemáge is supported by trusted advisor, user, and ambassador, Kathy Ireland, and featuring the innovation of Doctor David Scharp of Scharp Laboratories and his key active ingredient, MDFc19.
What is MDFc19?
California-based Sharp Technologies (apparently the same as or related to Sharp Laboratories?) describes MDFc-19 here this way :
(MDFc-19) is a new and important skin care component that contains a number of critical factors, which are produced by expanding adult human mesenchymal stem cells (MSCs).
As a formulation of human cellular factors, again I believe that it is at least reasonable to ask if this MDFc-19 product or other products such as Stemáge that include it are drugs.
The website goes on to say this about MDFc-19:
During our own cell culturing process, human adult MSCs readily expand and grow while releasing their growth and signaling factors into our proprietary media solution. When the stem cells are removed, these important factors are left behind, creating a critical new skin care component for skin care products (MDFc19). Clinical studies have shown that products containing MDFc19 can help reduce the effects aging skin.
What exactly are these clinical studies they claim? Hard to say.
On the clinicaltrials.gov website I found zero results for searches related to Stemáge, MDFc19, and David Scharp.
There was an MDFc19 Wikipedia page up until a few days ago, but Wikipedia editors deleted it. However, the cached page is still available here.
Interestingly, the removed Wiki page claims that they are collaborating with the very prestigious Sanford-Burnham Medical Research Institute.
Scharp Labs provides a page of more info that makes the claims that MDFc19 does the following:
Induces collagen production to increase skin thickness
Reduce scarring
Reduce inflammation and skin irritation
Improve skin recovery time from laser treatments
Reduce wrinkles
These are very impressive sounding, medical claims.
For example, they again claim that Sanford-Burnham is a collaborator, providing “the core scientific analysis for Stemáge”
I emailed a few people at Sanford-Burnham inquiring about this.
No answers yet.
In the end there seem to be more questions than answers about Stemáge. I wonder if the FDA is really OK with such a product and its claims?
As a mixture of human growth factors, cytokines, and other elements made from other people’s stem cells, it seems to me to have many characteristics of a drug.Again, it is not my place to say whether it is a drug or not, but in this case there seems to be reason for at least some concern.
For example, there are possible safety issues such as the potential of the product to contain human viruses, prions, or other human molecules or cellular fragments that could be worrisome. If the human stem cells are grown in fetal bovine serum (FBS), there is also the possibility that customers could be adding factors via Stemáge from fetal cow blood to their face.
Not a very attractive idea in my opinion. Hopefully that is not the case.
I will post Part 2 on Stemage in a few days including quotes from my remarkable conversation with a representative of the company regarding where they get the stem cells and more.
You won’t believe it….or maybe these days you will.
Is it really deja vu all over again with allegations of potential wrongdoing in a paper on human cloning?
“Say it isn’t so!”, is basically the universal reaction I’m getting from people in the stem cell field.
Well, sadly it seems to be so folks.
What’s going on?
Allegations have emerged on a website called PubPeer (a post-publication review kind of website) about the recent Cell paper by the Mitalipov lab on human therapeutic cloning.
A person called “Peer 1″ has pointed out alleged instances of image duplication and cropping in the paper. The story was also picked up by Retraction Watch. Science is on the story too. Just to be clear, I am not “Peer 1″ as some people have suggested.
A quick look at the paper would suggest there are indeed 3 separate instances of image duplication and images are cropped in various ways that make them look kinda different on first glance.
It makes one feel a bit queasy.
A fourth allegation of inaccurate representation of microarray data related to two panels in Figure S6 in the paper remains more difficult to confirm or deny to this scientist.
The other thing I’m hearing from readers of this blog and others is that they are astonished over the microscopic 3-day period (see image above from the paper) between when the journal Cell received the Mitalipov paper and when it was accepted. A leading stem cell scientist said to me, “Are you f’ing kidding me? 3 days for a human cloning paper?”
Given the 2004/2005 cloning papers by Hwang Woo-suk that proved to be bogus and the highly sensitive nature of human therapeutic cloning, an intense review of the paper before publication would indeed seem like it should have been a no-brainer, eh?
Another leader in the stem cell field told me that Cell should have had 5 independent reviewers look the paper over and have a highly detailed, methodical examination of the paper figure-by-figure, line-by-line, by at least two editors.
Now I’m hearing that we’ll see an announcement by OHSU and Cell as early as tomorrow about this, in all likelihood saying it was all a big innocent mistake.
Maybe it was. I’m betting that to some people though, there will always be doubts after this though.
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