Advancing Cellular Therapy with the Ace Pico Protocol: Overcoming Multi-Dosing Challenges in Stem Cell Applications

The Ace Pico Protocol, developed by ACE Cells Lab Limited, U.K., presents a novel approach to cellular therapy by mechanically dissociating stem cells into nanoscale fragments (5-20 nm, as confirmed by Electron Microscopy [EM] at 92,000x magnification) for sublingual delivery, aiming to overcome the challenges associated with multidosing in regenerative medicine. Multi-dosing, essential due to the short half-life of bioactive peptides and limited in vivo stem cell proliferation, often leads to immune reactions, patient discomfort, and increased costs. This study evaluates the protocol’s efficacy and safety through EM, UV-Vis spectrophotometry, and animal safety tests, comparing it to traditional methods. EM analysis of sheep brain cells revealed polydisperse fragments ideal for mucosal absorption (3 A) and pigments (405.5-573.5 nm), indicating bioactivity retention via a cold (<10°C) mechanical process. Animal safety tests (2000 mg/ kg, sublingual) on albino rats showed no toxicity, with minor physiological changes (e.g., increased water consumption and liver weight for brain extracts, decreased spleen weight for kidney extracts), supporting safety. A plasma protein study in mice across five administration routes (intramuscular, intravenous, subcutaneous, topical, sublingual) demonstrated significant increases postadministration (p<0.01), with sublingual delivery yielding the highest mean increase (0.66 g/dL), correlating with efficient absorption of nanoscale fragments. Compared to nanoparticle carriers, exosomes, and peptide therapies, the Ace Pico Protocol offers a superior single-dose, non-invasive delivery method with a comprehensive \"whole cell \" payload, reducing multi-dosing needs. However, high UV absorbance suggests potential scattering from undissolved particles, indicating a need for filtration optimization. These findings support the protocol’s potential to enhance therapeutic efficacy and accessibility, warranting further studies for refinement and long-term effects.

Keywords: Ace pico protocol; Cellular therapy; Stem cell applications; Multi-dosing challenges; Regenerative medicine; Nanoscale fragments; Sublingual delivery

Author(s): Dr. Alaa Abdelkairm Fouad, MD* and Prof. Mike Chan

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