The ACE Pico Protocol introduces a transformative platform in regenerative medicine and pharmaceutical biotechnology by converting stem cells into polydisperse nanoscale fragments (5–20 nm) through a cold (<10°C), mechanical dissociation process. This protocol enables non-invasive, multible-doses sublingual administration of a “whole cell” payload—including membranes, organelles, proteins, and nucleic acids—addressing longstanding challenges of multi-dosing, immune response, and patient compliance in cellular therapies.
Comprehensive analysis using electron microscopy (EM) and UV-Vis spectrophotometry confirmed the bioactive integrity of the processed materials, with strong absorbance peaks for proteins and pigments, and optimal particle sizes for mucosal uptake. In animal models, high-dose sublingual administration (2000 mg/kg) revealed no toxicity, while plasma protein studies across five administration routes demonstrated the highest systemic protein increase via the sublingual route (0.66 g/dL, p<0.01). These findings underscore superior absorption, therapeutic potential, and safety.
Compared to exosomes, peptides, or liposomal delivery systems, the ACE Pico Protocol offers broader therapeutic payloads, reduced degradation risk, and enhanced stability, making it a compelling platform for next-generation pharmaceutical formulations and biologic delivery systems.
Authors:
Dr. Alaa Abdelkarim Fouad , ACE Cells Lab Ltd, UK
Keywords: ACE Pico Protocol, nanoscale delivery, stem cell therapy, sublingual administration, pharmaceutical innovation, regenerative medicine, multi-dosing challenge
