288 – Angiogenic assessment of ORBCELTM, a novel stromal cell population for treating Critical Limb Ischaemia (CLI)

Human mesenchymal stromal cells (MSCs) comprise a heterogeneous population of ‘plastic-adherent’ (PA) cells that can be isolated from human tissues such as bone marrow, adipose tissue or umbilical cord. Currently, the clinical use of PA-MSCs for treating unmet medical needs such as CLI (a severe form of peripheral arterial disease) is facing significant challenges. In most cases, isolation procedures rely only on plastic adherence, which results in a heterogeneous cell product. Cells are then expanded to over 1010 PA-MSCs for therapeutic use in cleanrooms under Good Manufacturing Practice standards. The issue of low cell purity has been highlighted by the EU Committee for Advanced Therapies and the British Standards Institute. We believe this requires immediate attention and the development of novel isolation technologies. To address this aspect, Orbsen Therapeutics Ltd has developed proprietary technologies that allow isolation of a clearly defined and pure MSC population (ORBCELTM) based on a protein marker (CD362+). Orbsen Therapeutics has also worked with Miltenyi Biotech to develop a CD362+ selection process using the world first MEMs based sorting technology (Miltenyi MACSQuant Tyto Sorter) to enable the clinical translatability of the ORBCELTM product.