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 tissue necessary to conduct animal trials and recellularization
Obtain ethics committee approval for Phase II
Conduct animal trials, recellularization experiments, and publish results
Receive ethics committee and regulatory body approval for human clinical trials
Conduct a multi-stage, multi-cohort human clinical trial
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.
At the moment we have acquired the tissue we need for animal trials, had scientists join our team to work on phase II and whose expertise is relevant for an animal trial, and have been working on receiving regulatory approval to conduct such a trial.
We will use extracellular matrices created using the decellularization methods above to conduct animal trials, testing for biocompatibility and ensuring that the foreskin’s properties are maintained. Then, we will re-seed the extracellular matrices with the appropriate stem cells to fully regenerate human foreskins.
Once we have these regenerated human foreskins, and we have confirmed that they are identical to their anatomical counterparts, we will publish our results. Once we have established a successful method for regeneration of human foreskins, we will initiate the process to start human clinical trials (phase III). For an overview of our plans and research, see the roadmap detailed above.