We receive questions daily from our supporters as to the availability of foreskin regeneration and the time frame of when we will complete our research and move on to human clinical trials. In these early stages of research, it is impossible to answer all of these questions fully. That being said, we base our answers off of previous achievements in the field of regenerative medicine and our best approximations based off of our current information.
1.) What is Foregen's goal?
FULL regeneration of the foreskin, with all its neural infrastructure. For more info on this, see here.
2.) What will the expected procedure consist of?
As we get closer to clinical trials and ultimately complete them, we will, of course, have more details for you. For now, the following is a good description of what it should be:
Our process right now consists of decellularizing the adult donor foreskin, which means we strip away the cells until only an Extracellular Matrix (ECM) is left. This ECM is then reseeded with your own stem cells to regrow and regenerate the structures of the foreskin.
The surgeon will reopen the scar line then attach the foreskin via microsurgery and apply stem cells so that the current scar line is healed and there would be no additional scars. Additionally, because the skin is decellularized, once it integrates itself, your DNA will take the foreskin’s place. Out with the old, in with the new. That means that the foreskin will truly be yours, how it would have looked and all the parts and pieces just as it would be if you had never been circumcised.
Chances are, it won't even look like the donor after all is said and done because your cells will have grown anew and the old will have died off. The same process happens with all cells throughout the body.
Initially, it will be a donor foreskin from a cadaver. Once our procedure is commercially available in the future, we will also be working toward a 3D printing system, which is currently used for certain regenerative methods. This would be printed with the patient's DNA and properly innervated, along with the other structures of the foreskin to create a custom regenerated foreskin.
3.) How will the ridged band and frenulum be regenerated and attached? Will all the foreskin be regenerated and be completely functional? What about different sizes of remaining frenulum?
Yes, our goal is to regenerate all the structures and restore full functionality. The ridged band is part of the Extracellular Matrix (ECM) and will be regenerated alongside the other structures. The frenulum is also taken from the donor during the collection process and will be regenerated as well. Regardless of if you have a frenulum left or not, or one that is of different size, we will make sure it is regenerated and reattached.
4.) Some people claim that nerves atrophy over time due to a lack of stimulation. Will all the neurons and pathways responsible for the foreskin's erogenous response register with the new foreskin? For example, will the brains of men circumcised as infants be able to register their regenerated foreskin as if they had never been circumcised?
Even when circumcised, the remaining foreskin still sends all the information through the very same spinal neurons. While we might have tens of thousands of nerve endings, they all lead towards the same big channel(s) leading into the spine and finally to the brain. If your whole penis was removed at birth, then there might be cause for concern. But this way, the axons in your spine associated with your foreskin have always been used because they are used for the entire penis. We also know the brain can receive sensation from newly transplanted limbs. We've never seen how the brain reacts after receiving a foreskin post-circumcision because it has never been done - that is our goal, and we are confident it will be a success.
5.) Can the regenerated foreskin be adjusted to any penis size?
Yes, both the cadaver (donor tissue) and the 3D printing methods will achieve a foreskin adjusted to every patient.
6.) Will there be a scar where the new foreskin is attached?
There shouldn’t be a scar after the procedure because stem cells will be applied to the site of the surgery and should prevent scarring from occurring.
7.) What about phimosis? Or if I've had it before?
Foregen will make sure that each foreskin is custom fitted to the patient. Phimosis is not genetic but rather caused by some form of scarring (from the foreskin being forcibly retracted, for example). It should not reappear after Foregen's procedure. Furthermore, there are other ways to handle phimosis other than circumcision, so even if phimosis somehow occurred you won't necessarily require circumcision.
8.) How far has Foregen progressed in its research so far?
Right now Foregen has successfully completed the decellularization of both animal and human foreskins, most recently the human ones. We will be publishing and patenting the techniques used in these experiments. We will then move on to the next phase of our research, which will consist of animal trials to test the safety and efficacy of the decellularized foreskins. Depending on the results of those experiments, we will then work on recellularizing (regenerating) them. Foregen's push forward in research, of course, depends on supporter contributions.
9.) Where does the donor foreskin actually come from? Will I get a dead guy’s foreskin?
The donor foreskin is taken from a consenting, deceased adult male. However, it will not be a ‘dead guy’s foreskin’. The donor foreskin will undergo a process called decellularization that strips the foreskin of the donor’s cells and DNA, which reduces it to an Extracellular Matrix (ECM). This ECM is then seeded with your own stem cells to regenerate the structures of the foreskin, which means the foreskin will be truly yours.
10.) Your website often shows that you fall short of monthly donation goals. What will this mean for us? Delays? Postponement?
The $20,000 goal is to conduct our research full time, not reaching that goal means we won’t be able to hire our researchers full time, but with the expected change to for-profit this year, we should be able to start conducting full-time research soon. Also, conducting research in Italy is less expensive than it would be in comparison to the U.S., which enables us to maximize the utility of our current budget.
11.) How far away are we from conducting clinical trials?
Clinical trials are expected to start in 2019 granted we hit all our funding goals and research milestones in the interim.
12.) Will I have to go abroad to get the procedure or will it be available elsewhere?
Since our research is currently being conducted in Italy, that is likely where our procedure will be first available. However, since we know there will be demand around the world for our procedure, we will seek to expand where we offer it and make sure the proper approval is received.
13.) Will there be a big enough supply of donor foreskins before the 3D printing is available?
Due to the scarcity of the donor tissue, there will be a bit of a wait time, but we will try to get our supporters in first. Also as time goes on, we’ll be able to get more and more tissue from different countries around the world, given that most countries leave males intact. This means more opportunities to receive tissue from donors.
14.) Will the penis need to stay flaccid for a period of time after the procedure while everything heals and how will this be achieved?
Yes, the penis will need to stay flaccid for some time after the procedure in order to properly heal. There are medications that can be prescribed to prevent erections and therefore ensure full healing.
15.) How will stem cells be extracted from the patient?
At the moment there are several different methods we could potentially use, one of them being the patient’s blood to extract the stem cells.
16.) Does signing up for the clinical trials early increase your chances of getting in?
While it does register you as interested, it only means that we could potentially select you for the clinical trials. Acceptance will depend on age, health, and other reasons. We are not yet at a point to give a full list of requirements.
17.) So, since it’s all about research (and its funding), what kind of research is Foregen actually doing and how can you be so sure that it’s doable?
The very short answer: similar stuff has already been successfully done, and therefore Foregen's task doesn’t require a lot of pioneering work, but only the application of already existing technology.
The long answer: The keywords are regenerative medicine, stem cells, and stem cell medicine. Regenerative medicine is an umbrella term for all the medical disciplines that aim to restore functions in the human body that were lost completely either through injury, disease, age etc. One of the most promising disciplines in this important field of medicine is so-called "stem cell medicine“. In a nutshell, stem cell medicine uses stem cells to regenerate functional human tissues and organs. These can then be used as replacement parts for damaged or defective structures in the patient’s body.
Having explained this, why is Foregen so sure that they will fully regenerate the human foreskin? The answer lies in the past 10 years. Stem cell medicine has existed roughly since the discovery of stem cells in the 60’s and 70’s, and it has come a long way until it’s reached the level of expertise it has today. Through the successful research of some key components, stem cell medicine has enabled the creation of all kinds of tissues and organs in the recent past. You can find a comprehensive list of confirmed successful applications here. One very important, more recent achievement from 2015 has been the creation of full-thickness human skin. Full-thickness skin means skin that contains both the epidermal and the dermal layer. The epidermal layer is the ulterior protective barrier of the skin, while the dermal layer contains all of the infrastructure: Blood vessels, neural structures, hair follicles, sweat glands, and so on.
How exactly this stuff is done would take even longer to explain, but the above-posted link to Foregen's website gives a good overview of the basics. What should be clear by now is that Foregen doesn’t have to explore uncharted fields of science for this. Much more complex organs of the human body have already been successfully targeted, and although it will cost time and money to do the foreskin, it is absolutely doable within a reasonable time frame.
Below are some more links to reports about more recent successes in stem cell medicine:
The following quote is also taken from an article on Foregen from the UK Mirror in 2015:
”Dr. John Barker from the Frankfurt Initiative for Regenerative Medicine told Mirror Online that Foregen's ambition sounds plausible. Foreskin is already widely used to harvest skin cells for a variety of scientific applications, he explains, “so it would be fairly easy to adapt” the process for Foregen's purposes. He points out that similar tissue has already been engineered in the lab to make bladders, penis tissue, urethras and vaginas. Barker says it’s easy to generate the scaffold and harvest the skin cells, but the difficult part is the transplantation of the newly grown foreskin to the desired location. Getting the blood supply in place “could be tricky but doable”.”
18.) Now that I know everything about the science behind it, what about the economics. You need money to continue research, but how will that be settled? How are you funded? Most projects like this receive government funding.
Foregen is currently reliant on donations from our supporters. If you are interested, see this link for details: https://foregen.nationbuilder.com/donate
You can also follow this link for more details on our monthly expenses to understand where our donations go: https://foregen.nationbuilder.com/get_involved
Foregen’s spokesman, Eric Clopper, explained at the WSCS (World Stem Cell Summit) what Foregen wants to do and why, and he also presented them Foregen’s business plan. In short, it’s a 5 year, 5 phase business plan that consists of 3 financing rounds through which the research is funded.
19.) Does Foregen have the personnel to conduct the research?
Yes, Foregen has skilled scientists currently working on research. Dr. Elena Bondioli has over 10 years of experience in the field of skin regeneration, along with Dr. Valeria Purpura, who is also skilled in the field of regenerative medicine. Foregen will also look to hire more scientists and researchers as time goes on.
20.) Considering Foregen’s current status, what are the short and mid-term plans to cope with the current funding problem?
First, Foregen aims to transition to a for-profit organization in 2018. Through this Foregen aims to attract potent investors, who will help to fund the next phases of its research. However, Foregen is also simultaneously promoting itself through appearances in the public, medical conferences, awareness campaigns like HUFO (which was successfully funded in April 2015), and Pigs Without Blankets, a satiric documentary about circumcision culture in the US and Foregen’s role in coping with its consequences. We've also teamed up with Brendon Marotta, director of the award-winning film, American Circumcision.
We will look to publish two papers this year (2018): one on animal and one on human foreskin decellularization. Building off of that momentum, we will look to raise a large round of financing via equity investors once we’ve proven our ability to perform such a high level of scientific work. We’ve made strategic partnerships with life science brokers in New York City and crowdfunders in Boston and are looking forward to announcing our next big step in the process once we are legally able to do so (SEC and FINRA regulations prevent us from making certain forward-looking statements and we have no desire to become entangled in an unnecessary lawsuit with the federal government).
21.) How much will the procedure cost and will insurance be able to cover part of it?
Right now, we’re estimating about $10,000 total for the operation. However, we also want to have payment plans available to make the procedure more accessible. In terms of insurance, it will largely depend on the country and the culture. The more pro-circumcision a culture is the less likely it will be covered by insurance. Of course, a culture can change over time, and with changing views might come a willingness by insurance to cover the procedure. This is speculation so we can’t guarantee any of this will happen, but it’s something to keep in mind. Furthermore, the cost of the procedure, like other regenerative medicines, is likely to decrease over time:
22.) Will a restored foreskin interfere with the surgery?
We can’t say 100% right now how restoration will affect our procedure. It may just be a simple matter of removing the restored foreskin and reattaching the regenerated one. However, rest assured that if we need to create a procedure specifically tailored to restored or restoring men we will do so. We know there are many men who are currently restored or restoring so we want to make sure they can access the benefits of our procedure too.
It is also worth noting that neither Eric Clopper nor Vincenzo Aiello (spokesman and founder) are restoring. Both have stopped and are waiting for the technology to become available.
23.) How can Foregen regenerate nerves?
Regenerative medicine and the regeneration of nerves is a complex science. For a cursory understanding, the nerves are regenerated when the Extracellular Matrix is reseeded with stems cells converted from your cells, along with the foreskin’s tissue. For a more comprehensive understanding beyond the layman’s standard please consult this thesis titled Regeneration of Peripheral Nerves Using Neuroinductive Biomaterial Scaffolds by Paulina Sierpinski Hill. A PDF of this thesis can be downloaded from our site: Regeneration of Peripheral Nerves Using Neuroinductive Biomaterial Scaffolds
24.) Even if they regenerate nerves how will the recipient be able to feel them? How will the nerve endings link to the brain, and how can they be connected to the penis?
In other regenerative medicine projects, the nerves have been successfully regenerated, reattached and the recipient has gained full sensation. For instance, researchers grew vaginas in labs and implanted them in patients who were born with a rare genetic condition in which the vagina and uterus are underdeveloped or absent. In this case, the regenerated vaginas did integrate perfectly with women who were not even born with them. They went on to even report orgasm. Foregen is carrying out similar procedures for men’s foreskins.
25.) What about cancer? Regenerative tissue has the potential to become cancerous.
The risk of cancer in the regenerated foreskin is extremely low. There have been numerous examples of patients with implanted regenerated organs, parts of organs, and tissues dating back almost twenty years and have not reported cancer. The earliest transplant of a regenerated and implanted organ or tissue was in 1998. There have been other successes since then and no reported cancer.
26.) People have had their foreskin restored before in the form of plastic surgery. How is Foregen different to this?
The types of surgeries you are referring to involve the use of skin from another part of the body to create faux foreskin. This faux foreskin covers the head of the penis but lacks any of the unique properties of the foreskin, such as the ridged band, frenulum and inner foreskin mucosa. Furthermore, this plastic surgery does not regenerate nerves and the receiver cannot feel sensation in this faux foreskin.
Foregen is fundamentally different to this plastic surgery and should not be compared. Foregen is using regenerative medicine and stem cells to regenerate the whole of the foreskin and its unique properties, such as the frenulum, ridged band and inner foreskin mucosa. This is akin to how a salamander regenerates a lost limb. Foregen also seeks the regeneration of nerves and thus full sensation in the regenerated tissue.
27.) Will this involve more surgery? I don't want to have more surgery.
Yes, the procedure will involve surgery. Donor foreskins are decellularized, stripping them of donor cells and DNA, reducing them to an Extracellular Matrix. This is then reseeded with stems cells converted from your cells, regenerating the foreskin's structures. This is then attached to your penis at the scar line via microsurgery attaching all of the structures involved including nerves and blood vessels.
However, it is important to understand that such a procedure will fix your ailment; as opposed to circumcision which removes healthy tissue and damages the penis. Also, Foregen will employ skilled microsurgeons to carry out this procedure. Foregen’s use of stem cells will help minimize or reduce entirely scarring where the foreskin is reattached.
28.) How can Foregen define itself as a biomedical company? Aren't you just a commercial interest? Are you a tissue manufacturer? Do you employ people, or do you just have contacts with researchers?
Foregen is a biomedical startup that is researching the regeneration of the male foreskin. Currently, two researchers are employed through contracts. Dr. Elena Bondioli has over 10 years of experience in the field of skin regeneration, along with Dr. Valeria Purpura, who is also skilled in the field of regenerative medicine. Foregen will also look to hire more scientists and researchers as funds increase.
29.) How can I help Foregen reach their goal?
There are a variety of ways in which supporters can help us achieve our goals. The most direct way to help Foregen is to subscribe as a donating member. This allows us to plan ahead and continue our research, networking, and self-promotion. If you can’t donate, spreading the word helps significantly. Sharing our posts, videos, and news with other people and even making sure other intactivists are aware of our organization is an important step towards completing our goal. You may also consider volunteering. Please see our latest newsletter found on our website's blog to see open positions.