Throughout December and January, we have been conducting the next phase of our sheep trials, which involved utilizing a modified implantation technique to attach foreskin tissue to the sheep’s skin. This new approach involves “burying” the leading edge of the new tissue beneath the epidermal layer of the implantation site on the host’s body. The purpose of this is to determine the optimal method of ensuring full vascularization and innervation of the new tissue. With Dr. Angela Palumbo and Dr. Michele Riccio in the lead, the five PhD students have been conducting much of the hands-on work.
In order to attach the foreskin tissue to the sheep’s back, which is an optimal place for testing, the team must first shave the wool to create spatial clearance.
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Once the area has been shaven, PhD student Luca Pennasilico prepares the implantation site for the procedure.
Following these four implantation procedures, the team reported that the integration went well. They will now analyze the tissue, which will inform our subsequent research. This will involve an histological examination of the implanted tissue to measure the degree to which it has been vascularized and innervated. Once this is completed, the scientists will decide whether more work is required at this stage, or if we have achieved the results that we need to move on to the human clinical trials.
Implications for Human Trials
Our sheep trials were initially delayed due to inclement weather, and an unforeseen change in the ethics approval system at the University of Camerino. Additionally, the research required more time during the trial, because of our need to modify and implement new changes to our technique. Because of this, we will need to delay our human clinical trials. Unfortunately, such delays are common with this kind of research. This means that we cannot begin in April, and will instead have to ask you, our supporters, to extend a little more patience as we continue our work and move closer to our final goal.
In 2021 and 2022 we enjoyed phenomenal success alongside you, including astounding fundraising campaigns, the completion of rat trials, and the start of sheep trials. Now we look forward to 2023 with the goals of successfully completing sheep trials, and then moving to conduct human clinical trials. For now, our launch date is TBD, and we will update you as soon as we get a clearer picture of when we can begin. Moving the ball forward takes time, but we’re committed. We thank you for your patience and your support.
