Foregen is the only organization in the world dedicated to regenerating the foreskin and offering a solution to circumcised men.
We are utilizing novel tissue engineering techniques to regrow the foreskin with each patient's cells and ultimately reattach it.
Other techniques, like foreskin restoration, do not bring back full functionality, since some structures are permanently removed during circumcision.
Foregen's goal is foreskin regeneration, which has the aim of providing 100% of the functions of the foreskin.
We will produce a viable public procedure that can be marketed.
The aim of Foregen’s research is to regenerate the foreskin via tissue engineering techniques, and thereby restore its biological functions and benefits.
Below is a roadmap detailing our progress to date.
Acquire qualified scientists with properly equipped laboratories for research
Conduct preliminary experiments on animal tissue to prove a viable method for decellularization
Report results of preliminary research on animal tissue in scholarly article
Acquire regulatory approval as well as human tissue for decellularization
Conduct experiments on human tissue to prove efficacy of decellularization technique
Publish the results of human foreskin tissue decellularization in peer-reviewed article
Acquire necessary tissue and recruit scientists to conduct the animal trial
Obtain ethics committee approval for Phase II
Conduct a two part animal trial and publish results
Receive ethics committee and regulatory body approval for a human clinical trial
Conduct a human clinical trial with 15 participants.
Organize and subsequently release the procedure to the public
Foregen's research is available for academics, professionals, supporters, and the general public to view.
It is customary to experiment with animal tissue before any drug or procedure is first introduced for human patients. For this reason, Foregen decided that it was best that the standard method of decellularization be applied to bovine foreskins to prove that it is possible to decellularized a tissue that is both thin and elastic like the human foreskin. This served as a necessary proof of concept in order to pave the way for future research.
All decellularization methods tested in our study were able to create an ADM (animal dermis) displaying a drastic reduction of cell viability while maintaining a normal tissue morphology and structure. Our preliminary research experiments on animal tissue as proof-of-concept is available for a more detailed inspection here.
In this phase of our research we applied the decellularization technique developed by our scientists to human foreskin tissue to produce an ECM (extracellular matrix) suitable for further testing, and ultimately regeneration.
The results of the work are promising for Foregen’s aims. To summarize, the decellularization method we employed removed virtually all viable cells from the extracellular matrices. Additionally, the architecture of the matrices was left intact.
There was no difference in the mechanical properties of the decellularized matrices from native foreskin tissue. These decellularized matrices also exhibited a drastic increase in FGFb (growth factor) content, which we believe is a consequence of the decellularization process. This increase in FGFb content indicates high bioactivity, which essentially translates as meaning that the scaffolds have high regenerative potential.
Our research highlighting Phase I, the decellularization of human tissue, has been published in SAGE Journal of Tissue Engineering and is available, open-access, to read here.
We have acquired the tissue needed for Phase II animal trials, onboarded additional personnel and scientists with the pertinent expertise needed, and have successfully completed work on the rat model stage of the animal trial phase. This rat model stage was primarily focused on biocompatibility, and the experiments were a success. You can read a more detailed overview of that stage here. The second stage of Phase II will begin shortly with the sheep model. This stage will have a particular focus on vascularization and biomechanics.
Our method for both the animal trial and eventually humans is defined by an in vivo approach, where we will use the body itself as a bioreactor and incubator to regrow the tissue, taking advantage of the bioactive properties of the decellularized foreskin matrices we have.
Phase II animal trials will provide important data for the coming human trial and the techniques our surgeon plans to pursue in developing a surgical protocol for patients. Once we have this data and techniques established, we will have a clear path to Phase III, the human trial, currently planned to begin in 2024.
Following the successful completion of Phase II animal trials, Foregen will conduct a human clinical trial with a cohort of 15 specially selected trial participants. The exact selection process and criteria will be finalized at a later date as Phase III nears. However, as part of preparation for the trial, we have determined the general inclusion and exclusion criteria for these participants, which apply only and exclusively to human trial participants and not the public procedure, and have defined the patient follow-ups and what the goals of the study are specifically:
• Plastic surgical reconstruction of the foreskin and regeneration of the complete functionality of the involved organ
• To evaluate the regenerative efficacy and absence of any adverse reactions related to the use of homologous decellularized tissue from the Emilia Romagna Regional (ERR) Skin Bank
You can read more detail about the different facets of the human trial in the abstract here. The human trial is planned to begin April 1st, 2023, and last for one year until March 30th, 2024.