Human amnion epithelial cells and secretome-based therapy to reverse fibrosis

Overview

This solution addresses fibrosis, the endpoint of many chronic inflammatory diseases, which causes irreversible organ damage when extracellular matrix components accumulate excessively. Current dietary or pharmacological management is often insufficient or produces severe side effects. The technology uses human amnion epithelial stem cells (AEC) extracted from full-term placenta and amnion membrane, combined with their secreted mediators (the secretome), to reverse fibrotic damage. Preclinical and clinical evidence supports anti-fibrotic effects across multiple tissues, with demonstrated results in pulmonary, hepatic, and vocal fold fibrosis models. The approach targets intestinal fibrosis as a key application, with the potential to extend to other organs.

Technical specifications

Core technology:

• Multipotent human perinatal epithelial stem cells sourced from full-term placenta and amnion membrane
• Allogeneic treatment platform using both intact cells and cell-secreted mediators
• Patent-protected isolation method capable of producing hundreds of millions of AEC per donor
• GMP-compliant protocols for cell isolation and characterization

Mechanism of action:

• Paracrine signaling through extracellular vesicles (micro- and nano-sized) and soluble proteases
• Modulation of inflammatory response and stimulation of extracellular matrix remodeling
• Reduction of fibrosis through crosstalk with surrounding stroma and immune cells, including reduction of activated macrophages
• Capacity to be enhanced ex vivo using priming factors to strengthen long-term regenerative effects

Analytical capabilities:

• Ultrafiltration/tangential flow filtration for extracellular vesicle purification
• Planned implementation of size exclusion chromatography for routine isolation of vesicles and soluble components
• Non-coding and microRNA sequencing for profiling vesicle cargo related to intestinal ECM remodeling
• Comparative analysis of AEC products from vaginal delivery versus cesarean section tissues

Technology readiness level

The technology has reached preclinical validation in multiple fibrosis models. Human AEC has been successfully tested in pulmonary fibrosis, demonstrating reduction of inflammation and reversal of irreversible fibrosis. Direct injection of human AEC in a rabbit vocal fold fibrosis model showed reduced inflammation along with re-absorbance and remodeling of scar tissue. These preliminary results support further preclinical analyses aimed at confirming regenerative capacity and functional recovery in fibrotic tissues, with ongoing development focused on intestinal applications and optimization of the secretome isolation process.