Kathy Ireland Stemáge Stem Cell Product: Part 1, is it a drug?

I was alerted by a friend to the fact that there are now YouTube ads for stem cell products popping up, and one such ad features supermodel Kathy Ireland pitching for something called Stemáge Skin Care.

Updated (May 23): note that preliminary word from Sanford-Burnham is that they are not collaborating on Stemáge.

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).

http://youtu.be/6gt1CI3RrJY

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.

They also have a science page that is quite surprising.

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.