Stem cells sold for better sex part 2: bigger & better penis?

Does size matter?

Can a man get bigger and could he do it via stem cells?

Today’s post is the 2nd in a series on stem cells being sold allegedly for a better sex life. You can read the first post here.

An increasing number of men around the world are paying a lot of money for stem cell “enhancement” procedures. Such a procedure could put their health in danger as they strive to be bigger in that area. Men are also more often writing in to this blog asking about this topic, weighing risks to potential benefits.

For example, this message I received from a guy that I’ll call Ted, who said I could post it if I changed his name, tells the story pretty clearly:

“This is embarrassing. I’m having increasing issues with my wife about sex. She’s not a bad person, but she wishes I had a bigger package and could last longer. Can a guy get a bigger penis using stem cells? I’ve seen some ads on the web about this, but it is thousands of dollars and I don’t like the idea of someone injecting me there. Sorry for asking. I feel like an idiot.”

Apparently, at least argued in one recent report, for some women penis size does matter. Another study reported data on the average penis size amongst something like 15,000 men who were measured and the authors suggested guidelines for size related to people who might be candidates for augmentation. See graphs below from the paper indicating correlations between different methods of measurement.

;enis size data

For those men who might feel like their size is not where they’d like on those graphs in the paper, one might ask: Can a man get a bigger penis via stem cells?  

From Beverly Hills to Bangkok for-profit clinics say an emphatic, “yes!”

Bigger penis. Bigger erection. Better sex life. All through stem cells. And stem cell sex-related “treatments” for women too. If you have the cash to pay us.

Would this kind of stuff really work?

If you’ve got the necessary bank account to pay for it and can overcome the scary idea of injections or other procedures on your genitals, you could try it, but there are very serious potential risks and little published data to support doing something rather extreme like this. It would well make things worse instead of better. Such risks could include complete loss of sexual function, nerve damage, infection, and more.

From a broader perspective, stem cells are being sold to allegedly grow or improve all kinds of body parts including not only penises, but also breasts whether surgically or via that odd electric stem cell bra. Stem cells are also being sold to “rejuvenate” vaginas in women. What the heck?

It is important to distinguish these kinds of cosmetic procedures from breast or other tissue reconstruction after cancer surgery and also efforts to regrow penises damaged, for example, by battlefield injuries to male soldiers.

As I said, I’ve gotten a significant number of emails and comments on the blog from men like Ted who are seriously contemplating getting a “stem cell” enhancement and from women looking to deal with sexual dysfunction. It’s no April Fools Day joke to them. Some of the men want to be bigger and some have erectile dysfunction.

Who is selling this stuff?

There are many places, but I’m going to give two examples that are certainly not endorsements or specific criticisms. To be clear again, I discourage people generally from going this route because of serious safety concerns with such procedures.

The Stem Cell Rejuvenation Center makes a claim of selling better sex for $1,500 and up a pop via stem cells by procedures they call O-Shot for Women and Male-Shot. How stem cells could achieve their claims (listed below in red) is not clear to me and any kind of procedure is going to have risks:

  • “For women, the O-Shot offers:
  • Improve your marriage
  • Improve your sex life
  • Improve your relationship
  • Improve climax/orgasm
  • Better sex after menopause
  • Better sex after childbirth
  • Finally, something for women!! This is very exciting!! 
  • For Men, The Male-Shot offers:
  • Bigger erections
  • Improve your sex life
  • Improve climax/orgasm
  • Increased sensitivity
  • Increased libido”

I didn’t see any data on this to support these claims.

Another place called the Barron Centers in Beverly Hills offers stem cell-based phalloplasty.

On the Barron website they describe in great detail how the attempts to use fat or stem cells to get bigger penises has evolved over the years to get to today’s technology (emphasis mine):

“Fat is removed and placed in the penis the same as before, but it is processed in a way that separates stem cells from the rest of the fat, which are then injected into the fat in a very high concentration. A new blood supply is established rapidly which allows for a much better result.  There is a small amount of reabsorption, but nothing compared to what we used to experience.  There will be an increase in circumference of 30-40% either way.”bigger penis stem cells

See the cartoon image from their website that shows a schematic of a cross-section of the claimed bigger penis.

The doctor behind the Barron Centers is Dr. Rodney Barron. The idea seems to be to use fat tissue to increase size and stem cells to “grow” more tissue as well as stimulate increased vasculature.

It is important to note that the laboratory process of the material that they describe seems to me to be production of a specific stem cell-enhanced adipose product called SVF or stromal vascular fraction (more on that here). This is notable because the FDA to date has generally written about SVF as a drug requiring pre-approval and licensing.

The bottom line overall when it comes to stem cells for penile enlargement or even for a better sex life more generally is that it seems like an extreme way to go without clear data supporting efficacy and safety. There are likely to be some serious medical risks involved.

Note: This blog post is not medical advice and I’ll say again that I discourage people from getting these kinds of treatments due to the risks and many unknowns.

Was Fujifilm CDI acquisition a good move by the companies?

The big stem cell news already this week is the acquisition by Fujifilm of Cellular Dynamics International (CDI) for a whopping $307 million dollars or about $16.50 per CDI share. You can read the press release here.

It was less than two years ago that CDI did its IPO with an initial offering of about $46 million.Cellular Dynamics

Fujifilm reportedly has a multibillion-dollar war chest for buying into the life sciences sector and a growing interest in regenerative medicine. Note that there’s some fun, but perhaps over the top speculation going on in terms of whom they might snap up next.

CDI is an unusual company in the sense that it began about a decade ago with a very sexy idea of using human pluripotent stem cells to cure disease, but now as xconomy.com refers to it is focused more in the “unsexy” business of manufacturing cellular products from stem cells.Fujifilm Logo

Although the production side of regenerative medicine may not sound very innovative, it turns out that the reality is that making high-quality, functional, and pure differentiated cell products from pluripotent stem cells is no easy task. Throw in making such products from human induced pluripotent stem cells (IPSC) and it starts to become very exciting and important.

So was this a good move by Fujifilm and CDI?

Good news for the stem cell/regenerative medicine field overall?

My sense is an initial “yes” all around overall, but with some remaining questions.

If Fujifilm wants to grow a presence in IPSC and more generally the regen med arena, it now has made a big step forward. CDI has worked with CIRM, NIH, and a number of biotech companies. Again, the process of making the “real deal” pure, functional cellular products from IPSC is very important and valuable. The evolving CDI “superdonor” IPSC bank is very cool and could have huge value.

Perhaps something we could learn more about is how Fujifilm will make use of the unique IP of CDI specifically. Also how does the fact that CDI has to license IPSC technology via the Yamanaka Patents come into play? What about the overall price tag just over $300 million?

From the press release comes the Fujifilm perspective:

Commenting on the transaction, Shigetaka Komori, Chairman and CEO of Fujifilm, said, “We are delighted to be able to pursue the business from drug discovery to regenerative medicine with CDI, which develops and manufactures iPS cells. We have optimal scaffolding material, ‘recombinant peptides’, for cell generation and technologies useful for regenerative medicines such as material science and engineering. Our group company, Japan Tissue Engineering, markets regenerative medicine products in Japan. By welcoming CDI to the Fujifilm Group and by combining the technologies and knowhow of both companies, we will seek synergies and efficiencies to be more competitive in the field of drug discovery and regenerative medicine.”

From a CDI perspective, this seems like a major win for their team, who will benefit greatly financially from this deal. Although Fujifilm intends to maintain CDI as a Wisconsin-based subsidiary, as xconomy.com points out it’s not clear what this deal means for the employment of the 150+ CDI workers there longer term. “Synergies” and “efficiencies” after an acquisition can mean reductions in employees. It seems likely that Fujifilm will continue the momentum of CDI and help to give clinical meaning to the efforts of the CDI scientists:

Robert J. Palay, Chairman and CEO of CDI, added, “CDI has become a leader in the development and manufacture of fully functioning human cells in industrial quantities to precise specifications. CDI and Fujifilm share a common strategic vision for achieving leadership in the field of regenerative medicine. The combination of CDI’s technology with Fujifilm’s technologies, know-how, and resources brings us ever closer to realizing the promise of discovering better, safer medicines and developing new cell therapies based on iPSCs.”

For the field overall, this deal is good news. It would seem a clear, strong indicator of the great, concrete value of regenerative medicine and cellular therapies. Nearly a third of a billion dollars is nothing to sneeze at. Notably, this is not about clinical trials or that kind of specific pipeline, but more about concrete cellular products and technology. That’s an important distinction because in this sector oftentimes most of the value and growth emphasis is placed on rapid bedside potential.

Disclaimer: this post is not financial advice and the author has no financial interest in either company.

Got that grant hamster wheel feeling?

Work in academia and on grants?

Then you might have been getting that grant Möbius strip, hamster wheel, Groundhog Day kind of feeling…

The funding rate for the key so-called “R01″ NIH laboratory biomedical grant has never been lower. In the long run, R01s are crucial to the everyday running of most biomedical labs in America.

It might take 10-15 tries to get one grant if one assumes all other things being equal. Say you are better than the average PI, it still might take you 5-7 tries or more. Throw in a little bad luck and it could easily be even worse than one in 10-15 tries though.

It seems equally bad or even worse at NSF. Foundation grants are tough to get as well.

As a result today, unless you are a rare grant savant or something (and if you are, congrats!), it may feel like you are always writing a grant or two or three…kind of like the ants in Escher’s famous Möbius strip drawing below going around and around. Is there an end in sight?

Constant grant writing is not the historical norm.

When I was a trainee, PIs would write grants and then take breaks of months or even a year or two before writing another one. They had the needed time for other important aspects of their jobs.

EscherMobius

Now the norm seems to be more of an endless grant cycle. Almost every PI that I know can only rarely step off.

Of course most folks are not looking to be going in the same circle over and over, but rather they are working very hard to improve their grant applications. Still there’s a super bad grant mojo out there right now.

Any words of wisdom out there?

Genetically Modified Humans Now Inevitable?

human egg editDiscussion of concerns over heritable human genetic modification has spiked in 2015.

This dialogue is a good thing, but is it in a sense too late?

Are genetically modified (GM) people a foregone conclusion?

Rumors are swirling that upwards of four papers reporting production of GM human embryos are in various stages of review at high-profile journals, sparking a sense of urgency for some kind of steps to deal with this new reality. Could these papers report germline correction of the CTFR mutation in cystic fibrosis or of a BRCA1 mutation? Were these GM human embryos used to make embryonic stem cell lines or are they cryopreserved?

The prime concern now is that GM human embryos could in principle be rather simply turned into GM humans at any one of thousands of IVF clinics around the world with a surrogate mother. That simple technological step of going from GM human embryo to GM human being of course invokes incredibly complicated, thorny legal, bioethical and societal issues.

So stakeholders have been weighing in recently on anticipating how to deal with this evolving situation.

Lanphier, et al. in Nature recently made the case in a piece called “Don’t edit the human germline” that GM human embryos should not be produced. Baltimore, et al. argued in Science for increased dialogue, but stopped short of proposing any kind of moratorium. ISSCR called for a moratorium on attempts at clinical applications of human nuclear germline modification.

My own take on this has been a more practical, specific approach that I call the ABCD plan that draws a bright line between allowable in vitro work (under very specific, mandatory rules, training, transparency, and oversight) and in vivo applications.

As this positive dialogue has proceeded, there is a troubling backstory. The sense I’ve gotten from some of those in the know is that there are researchers already intent upon going ahead to make GM human beings. Some believe it is not a question of if, but rather when and under what circumstances.

Interestingly, while there has been talk that from a legal and regulatory perspective that such an endeavor would “not be allowed” currently, I’m not so sure.

For example, here in the US if a GM baby was made, what could anyone do after the fact? Would the FDA really take some kind of punitive action and wouldn’t it be too little too late anyway? What about in China? I’ve heard people say there are regulations against making GM humans in China, but would they be effective?

If it is not too late to stop the production of GM people at this time, are there things we could be doing now besides increased dialogue to chart a safer path forward? If so, my sense is that time is short.

Risks for Healthy PBSC Donors? One Family’s Powerful Experience

By Jane Langille

A few weeks ago, I wrote to Dr. Paul Knoepfler after reading his book Stem Cells: An Insider’s Guide because I was intrigued by his stem cell theory of aging. I wondered if his theory might mean that someone who mobilized and donated hematopoietic cells might be shortening their own lifetime supply. After exchanging emails about my daughter’s experience, he invited me to contribute a guest blog as he felt that the complexity of her experience as a donor and the questions I was raising would be of interest to the stem cell community.

Peripheral blood stem cell (PBSC) donation is a miraculous treatment that provides people with high-risk forms of blood cancers and other immune diseases a last chance for a cure when other treatment options are exhausted.

As of December 2012, the number of hematopoietic stem cell transplants worldwide passed the 1 million mark, a remarkable accomplishment reported in a retrospective study published recently in The Lancet Haematology. Data collected by the Worldwide Network for Bone and Marrow Transplantation showed that across 75 countries, 42% of hematopoietic stem cell transplants (HSCTs) were allogeneic and 58% were autologous.

The preparation for cancer patients prior to receiving a donation is brutal. Their immune system is wiped out with high doses of chemotherapy and/or radiation therapy so their body is ready for an infusion of healthy, donated hematopoietic stem cells that hopefully find their way into niches in the bone marrow where they divide and produce healthy blood cells. The human leucocyte antigen (HLA) match between the donor and recipient must be as close as possible to minimize the risk of rejection.

It’s a remarkable treatment that helps many critically ill people. But what are the short and long-term risks for healthy donors?

Those were the questions I was contemplating in the spring of 2013 when my daughter Katherine, 22 at the time, turned up as a perfect match for an unknown patient in the bone marrow registry. I was worried about her decision to donate from two different perspectives: as her mom; and as a health journalist.

Short-term issues

As her Mom, I was proud that Katherine had a big heart and the courage to donate a gift of life to a complete stranger. According to some reports, only about half of the people who are identified as matches in the bone marrow registry follow through. This was the child who had to be bear-hugged for childhood vaccines, so I was surprised she was volunteering for a procedure that would mean self-injecting a growth factor drug, twice a day for four days, followed by leukapheresis, which requires being tethered to blood filtering equipment with cannula in both arms for hours.

I also wondered how she would manage the stress, given that the donation was squeezed in between grad school interviews, final exams and her thesis presentation in her final year of university. The information provided by Canadian Blood Services’ OneMatch Stem Cell and Marrow Network said that donors would feel tired and achy for 5-7 days and there were possible complications of spleen rupture, but those symptoms would return to normal fairly quickly after donation was completed.

Long-term worry

As a health journalist, I had another worry. I didn’t like that the growth-factor drug she had to inject for four days prior to donation had an unproven safety profile among healthy donors and was an off-label use. The consent forms said, “No long-term safety information is available.”

The FDA approved the drug Neupogen in 1991. The drug contains the active ingredient filgrastim, a granulocyte colony-stimulating factor. The FDA approval and subsequent updates show that Neupogen was approved for autologous use among cancer patients, with no mention of allogeneic use by healthy donors. There is also no mention of healthy donors in the prescribing information.

Neupogen

A 2007 paper in the British Journal of Haematology mentions that since 1997, the US National Marrow Donor Program has maintained an Investigational New Drug application for the manufacture of PBSC products from unrelated donors and that “it is unknown whether filgrastim increases or decreases an individual’s risk of developing cancer” but added, “based on limited long-term data from healthy people…no long-term risks have been found so far.” Not exactly reassuring.

The only prospective trial I could find assessing the safety of filgrastim-mobilized stem cell donation and PBSC leukapheresis among healthy donors is currently underway and will not be completed until January 2022. The description says that filgrastim is “not a licensed indication,” and mentions that data collection began in February 1997.

The decision to donate

So the crux of the decision came down to this: should she risk an unproven drug treatment so that she could give a complete stranger another chance at life?

As a 22-year old adult, it was Katherine’s personal decision to follow through. She self-injected filgrastim twice a day and had the usual symptoms of bone aches, headache, and fatigue. She donated over two days, tethered to the apheresis machine for about 5 hours each day in a room where the other 10 treatment chairs were filled with cancer patients receiving chemotherapy and plasma treatments.

Kat-OneMatch-Donation-2

It was an odd juxtaposition for everyone involved, but the equipment and staff were located there. A second day is not always required, but it turned out that the recipient was apparently 15 kg (33 lbs.) larger than she was and the target collection calculation depends on body weight.

After her donation days, she traveled by train back to her university town three hours away to study for final exams and work on her thesis presentation. Three weeks later, she had an enlarged spleen scare, which prompted a visit to her local hospital ER via ambulance and had to restrict her activity to prevent a ruptured spleen. The donation hospital in Toronto then requested she travel back for a check a couple of weeks later. By then, thankfully, her spleen was back to normal size. She was well enough to do a karate grading a few weeks later and over the last two years, has had no complications.

At the one-year mark, she contacted OneMatch to find out if it would be possible to exchange contact information with the recipient, as the rules allow for that if both donor and recipient agree. She learned that the recipient lives in a country where there is a two-year restriction on information exchange. She doesn’t really want to know the recipient, but someday would like to know how they fared with her gift and if it made a difference.

There’s no question I’m proud she followed through with a donation. Even better — she’s proud. Katherine says, “In any case, I’m happy to know that my gift likely brought hope to the recipient and their family.”

The stem cell theory of aging

Dr. Knoepfler provided some helpful perspective about how a one-time mobilization of stem cells might affect a donor’s long-term health. He said, “In principle, boosting production of stem cells for a PBSC donation could have long-term effects. My feeling in the grand scheme of life is that a short-term, one-time mobilization of PBSC is unlikely to have a lasting effect on an otherwise healthy young person. Given the massive turnover in blood cells (something like a trillion blood cells are replaced per week for each of us), our hematopoietic stem cells have got to be very robust and for the dozens of times in our lives when we get sick enough to mount a major immune response, our stem cells are mobilized repeatedly each time.”

Bottom line

Is it admirable to donate and give someone else a chance at life? Of course! But I wish donors could have more information on how the procedure might affect them in both the short and long term, to understand more about what they are risking in order to help someone else. Here’s hoping that the study currently underway finds minimal risks for donors. In the meantime, it was great to get some perspective and reassurance from a scientist working in the stem cell field.

Jane Langille is a health journalist and mom based near Toronto, ON, Canada.