The ACE Pico Protocol: A Breakthrough in Multi-dosing Cellular Therapy for Pharmaceutical and Biotech Application

About this presentation

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

Speaker Bio:

Dr. Alaa Abdelkarim, graduated from Cairo University medical school. He is Founder and Chief Medical Offi cer of ACE Cells Lab Limited, UK. He is a Consultant- endocrinology and stem cells therapy. He has more than 35 years of experience and served in more than 8 countries. He received Fellowship of Royal Society of Medicine, Royal Collage of Chemistry, Fellowship of the Malaysian Association of Endocrinology and the International association for stem cells research. He has been the head of department of endocrinology and diabetes for more than 8 years treating complications of diabetes by cellular applications. He has worked in the cell therapy since 2002 and headed the research department of cell therapy in many international labs. He is an international Lecturer in more than 20 countries. He has registered 20 patents in the fi eld of cell therapy and the protocols to extract the bioactive materials from live cells either autologous or from external sources (animal source). He is leading 2 multi-centre clinical trials in neurodegenerative disease, controlling the complications of diabetes mellitus type II by cellular applications. He is the Founder of ACE Factor deficiency theory which is considered as the new trend in regenerating tissues. With many publications and lectures in treating Multiple Sclerosis, Cerebral palsy and Amyotrophic lateral Sclerosis in different parts of the world he has supervised many master and PhD researches. Cuurenrly running clinical trial number NCT06787482 with title Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies (ACE Retino)