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 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 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 with a micro surgery 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 towards offering 3D printed foreskins. This will be printed with the patient's DNA and properly innervated, along with the other structures of the foreskin to create a custom regenerated foreskin.
2. 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 left over 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 the process and will be regenerated as well. The frenulum will be reattached via a microsurgery.
3. 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 that experiment. We will then move on to the next phase in 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.
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 will 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 chopped off 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.
5. 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.
6. How far away are we from conducting clinical trials?
Clinical trials are expected to start in 2019, especially with the help of you all supporting us.
7. 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.
8. 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.
9. Will there be a scar where the new foreskin is attached?
No, there won’t be a scar after the procedure because stem cells will be applied into the site of the surgery and will prevent scarring from occurring.
10. 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.
11. Will restoring our foreskins now affect the procedure?
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.
12. 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.
13. 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.
14. How will stem cells be extracted from the patient?
At the moment there several different methods we could potentially use, one of them being the patient’s blood to extract the stem cells.
15. 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 still not at that point yet to give a full list of requirements.
16. 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.
18. 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 networking, self-promotion and research. If you can’t donate, spreading the word also helps a great deal. Sharing our posts, videos, and news with other people and even making sure other intactivists aware of our organization is an important step towards completing our goal.