On June 24th, 2022, the second stage of our animal trials, involving the implantation of human foreskin tissue onto sheep test subjects, began at the University of Camerino. These experiments are helmed by Dr. Angela Palumbo and Dr. Michele Riccio, overseeing a team of five veterinarians and students. Foregen Founder Vincenzo Aiello visited the facility to check in on the team and document their progress.
In our initial research stage we learned how to successfully deploy our unique approach on rats without the host’s immune system rejecting the implanted tissue. Now, we are testing additional capabilities of our unique method. The essential purpose of our sheep trial is to ensure the full vascularization and innervation of the implanted decellularized tissue on our subjects.
The study includes 6 sheep that have multiple implantation sites for the testing of the decellularized tissue. For the implantation, we are making use of silicon holders that have a structural model compatible with the anatomy of the human foreskin, and also prevents membrane collapse. The process of implanting the scaffolds is staggered, starting with smaller scaffold sections and proceeding to larger ones, in order to test the effectiveness of the engraftment and the resulting vascularization and innervation.
By confirming our ability to grow new foreskin tissue with full innervation and vascularization, without it being rejected by the host’s immune system, we will be adequately prepared to proceed to the next stage of our research: the human clinical trials. At this point, we will deploy the method we’ve tested on both rats and sheep onto volunteer participants and test it in vivo. These experiments are tentatively scheduled to begin next year.