Regenerative Medicine & Tissue Engineering
It is customary to experiment with animal tissue before any drug or procedure is first introduced to human patients. For this reason, Foregen decided in our preliminary it was best to perform the standard method of decellularization on bovine foreskins to prove that it is possible to decellularize a tissue that is both thin and elastic like the human foreskin. This served as a proof of concept in order to pave the way for future research.
All decellularization methods tested in our study were able to create ADM (animal dermis) displaying a drastic reduction of cell viability whilst 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 in a scholarly article here.
Animal tissue from the preliminary research.
Phase I Research
In this phase of our research we applied the decellularization technique developed by our scientists to human foreskin tissue to produce an ECM suitable for further testing, and ultimately regeneration. The results of the work are quite promising for Foregen’s aims. To summarize, the decellularization method we employed removed virtually all viable cells in the extracellular matrices. Additionally, the architecture of the matrices was left intact. There was also no difference in the mechanical properties of the decellularized matrices and native foreskin tissue. The decellularized matrices also exhibited a drastic increase in FGFb content, which we believe is a consequence of the decellularization process. This increase in FGFb content indicates high bioactivity, which effectively translates to meaning 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.
For a more comprehensive breakdown of our recent paper, please consult this primer we published.
We will use the extracellular matrices obtained via these decellularization methods 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 these human foreskins are identical to their anatomical counterparts, we will publish our results. Once we have established a successful method for regenerating human foreskins, we will initiate the process to start human clinical trials. For a more detailed rundown of our plans, click here.