Engineered skin therapy
Propagenix’s EpiX technology has proven capable of trillion-fold expansion of human keratinocyte stem cells. The limited number of primary keratinocytes isolated from a pea-sized skin punch biopsy can be expanded into hundreds of billions of keratinocytes in a few weeks to produce skin sheets covering several square meters (an adult person’s total skin area is about 1.8–2 square meters). The extensive proliferative runway of the primary keratinocyte stem cells enables genetic engineering in the adult stem cell population. Comparative studies between EpiX vs. current state-of-the-art keratinocyte expansion methods have demonstrated the superiority of EpiX technology in generating fully differentiated skin grafts after extensive expansion. We have also developed a bi-layered skin structure (with both dermal and epidermal layers) which recapitulates normal skin architecture that includes a robust basal stem cell population. Our next goal is to translate this technology into a clinically-ready form, including cGMP manufacturing of the engineered skin grafts.
Engineered airway epithelium models and theranostic assays
Our technologies support >1012-fold expansion of human airway epithelial cells that can subsequently form a differentiated mucociliary epithelium with various cell types (multiciliated, goblet, secretory and basal cells). These technologies are being deployed by us and by our partners to create in vitro models of human airway epithelium (both at air-liquid interface and as 3D organoids). These in vitro models are also being applied for therapeutic research applications including engineered tracheal grafts and lung recellularization. With the support of a commercialization grant from MSCRF and an SBIR grant from NIH, Propagenix is pursuing an internal program focused on expanding nasal epithelial cells from minimally invasive nasal brushings from cystic fibrosis patients and creating differentiated tissue models to test the efficacy of targeted drugs using the gold-standard Ussing chamber assay in vitro. Proof-of-principal work has demonstrated both the feasibility and utility of this functional theranostic assay as a diagnostic test to evaluate individual patient responsiveness both to approved treatment regimens and to new drugs in development. Further validation work is ongoing as part of this SBIR-funded program.