Blue cells are responsible for the clinical effect in erectile dysfuntion and lymphedema
Although the literature provides compelling evidence for the safety and efficacy of ADRCs, the nature of acquired cells is highly heterogeneous and different methods of isolation and preparation yield different and often inconsistent results regarding relative amounts of stem/progenitor cells and mature cells. On top of that, most researchers employ expanded cells cultured under different conditions including media, addition of growth factors and passage numbers. Therefore, it is important that we develop better markers of the cells that are important for the clinical effects and use standard methods to characterize the cells. We have made an interesting observation since the so-called ‘Blue Cells’ in the ADRC mixture correlated with the clinical effects in our phase I trials for ED and lymphedema. These cells were identified by flow cytometry using an antibody against a surface marker of the Blue Cells. We are in the process of testing isolated ‘Blue Cells’ in in vitro, animal experiments and in patients with ED and lymphedema. Industry and biotech partners will help in getting the ‘Blue Cells’ developed as a product that can obtain EMA/FDA approval and get to the market. Due to pending patent applications, we cannot further specify the biological entity of ‘Blue Cells’ at this stage.