Stem cell snake oil for sale at Nordstrom, Amazon, & Ebay?

stem cell microneedlingStem cells are exotic things ensconced away in biomedical research labs, right?

Well, maybe not entirely so these days.

It turns out that you can try to sell products for a lot of money by slapping “stem cells” on the label.

Take Nordstrom’s.

It has 80 stem cell products available online. These cosmetic products range in price up to $850 for the priciest one, ‘Bee Venom & Placenta’ 24 Carat Gold Ultimate Crème from Rodial.

These kinds of things are for sale despite an FDA takedown of L’Oreal/Lancome for iffy “stem cell” cosmetic products a few years back.

This Rodial cream is described this way: “Rodial Bee Venom & Placenta 24 Carat Gold Ultimate Crème is an exquisite, rejuvenating moisturizer with melittin peptide, liquid gold, stem cells and biomimetic growth factors from placenta.”

What a combo, huh?

The most expensive stem cell item on E-bay also seems downright scary. The ProCell Therapies Microneedling Stem Cell Hair Regrowth Micro Needle Therapy Kit sounds like a torture device to me. A bargain at $1,575, right?

Amazon has thousands of stem cell products (including books!), but the most expensive non-book stem cell item is an odd stem cell cosmetic. For only $3,757.96 you can get a 6 pack of Dermaheal by Stem C’rum Cell Revitalizing Solution –6 Applications for WOMEN.

Let the buyer beware.

Is this stuff snake oil or could it actually help people? What do you think?

PB&J as a kid versus now

Peanut mobileWhen I was a kid I would sometimes have a peanut butter and jelly sandwich. PB&J, as we called it, was a good choice for lunch. No refrigeration needed, not that we worried that much about that kind of thing back then just like seatbelts and secondhand smoke.

Thinking back, PB&J in the 1970s was a very different creature than today.

My PB&J as a kid came most often on something like Wonder Bread. The peanut butter would like have been Skippy or Jif. The jelly probably was grape or strawberry, and my mom or I would put a really thick layer.

Today I still every so often eat a PB&J, but the me of the 1970s might have been a bit puzzled at this PB&J of today.

My PB&J is always on whole wheat. There’s no white bread in our house. For the peanut butter we are spoiled to have the Davis Food Co-op’s freshly ground from peanuts. It smells really good. You can even grind it yourself there and it comes out warm. The “jelly” for PB&J today for me is often the whole fruit kind of thing. Taken together it is delicious.

The other thing that is different about PB&J today is something I learn from my kids. At school they often are not allowed to eat PB&J at all because of fellow students’ peanut allergies or if they are they have to be wary of where they sit because sometimes there are peanut-free tables.

In December I was in Atlanta for a meeting (see my post on visiting MLK’s birth home) and saw a peanut mobile (above). I know that 1970s kid version of me would have loved to have seen both MLK’s house, as he was a hero of mine, and a peanut mobile.

What do you think of PB&J’s? Take the poll.

TGIF weekend reads: stem cells, GMOs, #CRISPR, cats, cloning and more

Sounds recommended weekend reads for you to enjoy since it is Friday and almost the weekend.

Holy GMO, China wants to buy Syngenta.

cat stem cellsRetractionWatch says that Macchiarini will soon be out at Karolinska. For more on this “super surgeon” who used stem cells, see here regarding recent Vanity Fair Expose.

David Jensen on CIRM and human genetic modification: no germline work funded now, but possible in the future.

This is pretty awesome. Canadian ‘dream team’ to probe stem-cell link to brain cancer

If you mix cats and stem cells, it’s got to be good, right? Cat stem cell therapy gives humans hope

And now onto mice. Suicide of aging cells prolongs life span in mice

Human gene editing. For the first time in history, a government has approved genetically editing human embryos

And for laughs…

Mix GQ magazine and a cloning conspiracy = good for a laugh. Forget the ‘Flat Earth’ Stuff, B.O.B Thinks Celebrities Are BeingCloned

ViaCyte on the Rise: First Diabetes Trial Data & Acquires BetaLogics IP

Clinical research on Type I Diabetes is one of the most exciting and promising areas of stem cells and regenerative medicine for human disease.

Two of the coolest companies out there in this arena have been ViaCyte and BetaLogics (owned by J&J). For more on ViaCyte see my interview with President and CEO Paul Laikind from 2015.

VC-01 post-implant final

VC-01 post-implant

Today brings great news for ViaCyte on two fronts. Incidentally, this gives me a correct prediction on my Top 20 stem cell predictions for 2016.

First, it has acquired the assets and IP of BetaLogics, bringing together two of the best biotechs to use stem cells to fight Diabetes. This is a very exciting move and will strengthen ViaCyte. The terms of the deal were not released. This is also good news for Diabetes patients as this seems likely to give ViaCyte a big boost. ViaCyte’s press release quoted Laikind:

“For more than a decade BetaLogics and ViaCyte have been independently working toward a stem cell‐derived therapy for diabetes. By combining the intellectual property and other assets of BetaLogics with ViaCyte, we will further strengthen our advanced program focused on

insulin‐dependent diabetes and solidify our leadership in the field,” said Paul Laikind, PhD, President and CEO of ViaCyte. “We look forward to delivering effective new treatments for this difficult disease.”

Second, ViaCyte has had some notable success in producing the first data in its Phase 1/Phase 2 clinical trial called STEP ONE (Safety, Tolerability, and Efficacy of VC‐01 Combination Product in Type One Diabetes). From the company on this development:

  • “The data show that pancreatic progenitor cells (PEC-01) within VC-01 can engraft, vascularize, and differentiate into pancreatic beta islet cells (insulin-producing cells) 12 weeks after implantation.
  • This is an important milestone in the development of a “functional cure” for type 1 diabetes.  And an important milestone for the industry — the clinical trial is supported by JDRF and CIRM (California Institute for Regenerative Medicine)
  • The goal is for the PEC-01 cells in VC-01 to mature and secrete insulin and other regulatory factors in response to blood glucose levels.  “

Together these events solidify ViaCyte’s leadership in the area of stem cell-based treatments for Diabetes.

NAS proposes prudent US policy on 3-person IVF

3-parent babyA new report from the National Academies of Sciences, Engineering, and Medicine here in the US recommends a policy significantly more cautious on first read for 3-person IVF than that in place now in the UK.

My initial take on this new 164-page report is that it is very well thought out and the recommendations are both appropriate and prudent. I’m still reading the report so it is possible I may feel differently at the end or that others may point out concerns that I missed, but so far my impression is positive.

Keep in mind that 3-person IVF also goes by the monikers mitochondrial transfer, 3-parent IVF, and mitochondrial replacement therapy (MRT, the term used by the Academy).

Alta Charo Mito TransferNotably, the Academy committee explicitly stated that MRT is a form of human genetic modification and human germline therapy. Some proponents of MRT in the UK and even in the US had mysteriously claimed otherwise.

While the Academy committee wrote in the report that 3-person IVF is ethically permissible in theory, in practice the depth of their concern about the risks of this technology was reflected in the array of conditions that they detailed must be met first.

These conditions include, but are not limited to the following as taken in some cases verbatim from the report or the Academy press release:

  • initial MRT clinical investigations should be limited to women who are at risk of transmitting a severe mitochondrial genetic disease that could lead to a child’s early death or substantial impairment.
  • Only male embryos should be permitted to be used for pregnancy. This would avoid transmission of the donor mitochondria should something go wrong.
  • initial safety is established and risks to all parties directly involved in the proposed clinical investigations are minimized, although minimizing risk to future children should be of highest priority; (note, my interpretation of this is that more preclinical data are needed)
  • the likelihood of efficacy is established by preclinical research using in vitro modeling, animal testing, and testing on human embryos as necessary;
  • if the intended mother at risk of transmitting mitochondrial disease also desires to carry the pregnancy, it is determined by professional opinion that she is able to complete a pregnancy without significant risk of serious adverse consequences to her health or the health of the fetus;
  • clinical investigations are limited to investigators and centers with demonstrated expertise in and skill with the relevant techniques; and
  • FDA has reviewed the science surrounding matching the mitochondrial DNA subtype of the egg provider with that of the intended mother and if compelling, has considered such matching as a means of mitigating the possible risk of incompatibility that could arise from combining the egg provider’s mitochondrial DNA with the nuclear DNA of the intended mother.

I’m largely in agreement with the Academy on this policy recommendation. It seems wise and frankly more appropriately cautious based on the science than what is now allowed in the UK.

The policy recommendations were summed up by the committee Chair in this way:

“In examining the ethical, social, and policy issues associated with mitochondrial replacement techniques, we concluded that the most germane issues could be avoided if the use of these techniques were restricted by certain conditions, rather than prohibiting them altogether,” said Jeffrey Kahn, chair of the committee and the Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy at The Johns Hopkins Berman Institute of Bioethics in Baltimore.  “Although MRT would not treat a person with a mitochondrial disease, its pursuit could satisfy prospective parents’ desire to bear genetically related offspring with a significantly reduced risk of passing on mitochondrial disease.  The limitations on MRT that we propose focus on protecting the health and well-being of children born as a result of the techniques.”

Now it will be interesting to see how and to what extent the FDA implements these policy recommendations as well as the response in the scientific community. I would predict that some proponents of MRT may view this policy as too restrictive. Perhaps some might interpret it as a green light, but so far in my reading I don’t see it that way.

The other fascinating thing is to compare this report on 3-person IVF to the organizer’s closing statement from the NAS Meeting on Human Gene Editing from December. Some of the issues raised in the new report on 3-person IVF seem to directly apply to human gene editing as well.

I appreciate that the committee was cognizant of larger issues such as transparency, access, and public discourse.

Here is the committee roster.

Jeffrey Kahn, Ph.D., M.P.H. (chair)

Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy Berman Institute of Bioethics

Johns Hopkins University

Baltimore, M.D.

Jeffrey R. Botkin, M.D., M.P.H.

Chief

Division of Medical Ethics and Humanities, and

Professor of Pediatrics

University of Utah School of Medicine

Salt Lake City, U.T.

David Chan, M.D., Ph.D.

Professor of Biology

California Institute of Technology

Pasadena, C.A.

R. Alta Charo, J.D.1

Warren P. Knowles Professor of Law and Bioethics

School of Law and Department of Medicine and Public Health

University of Wisconsin at Madison

Madison, W.I.

James F. Childress, Ph.D.1

University Professor and John Allen Hollingsworth Professor of Ethics

Department of Religious Studies

University of Virginia

Charlottesville, V.A.

Alan H. DeCherney, M.D.1

Associate Clinical Director and Branch Chief

Intramural Program in Reproductive Endocrinology and Gynecology

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Institutes of Health

Bethesda, M.D.

Marni Falk, M.D.

Assistant Professor of Pediatrics

Division of Human Genetics

Children’s Hospital of Pennsylvania

University of Pennsylvania Perelman School of Medicine

Philadelphia, P.A.

 

Jonathan Kimmelman, Ph.D.

Associate Professor in Biomedical Ethics

Biomedical Ethics Unit

McGill University

Montreal, Canada

Anna C. Mastroianni, J.D., M.P.H.

Professor

University of Washington School of Law

Seattle, W.A.

Vamsi K. Mootha, M.D.2

Investigator

Howard Hughes Medical Institute, and

Professor of Systems Biology and Medicine

Harvard Medical School

Boston, M.A.

Laurie Strongin

Founder and Executive Director

Hope for Henry Foundation

Washington, D.C.

Keith Wailoo, Ph.D.1

Townsend Martin Professor of History and Public Affairs

Department of History

Woodrow Wilson School of Public and International Affairs

Princeton University

Princeton, N.J.

STAFF

 

Anne B. Claiborne J.D., M.P.H.

Responsible Staff Officer

Rebecca English, M.P.H.

Program Officer

Morgan Stathem, M.S.

Associate Program Officer

Michael Berrios

Senior Program Assistant

_________________

1Member, National Academy of Medicine

2Member, National Academy of Sciences