Blue Cell Therapeutics is a biotech developing long lasting allogeneic “off-the-shelf” human mesenchymal stem cell (MSC) therapies for severe erectile dysfunction and other diseases where angiogenesis and nerve regeneration are beneficial. Blue Cell’s therapy offers a potentially curative solution, restoring erectile function for extended periods and spontaneity to sexual encounters. Blue Cell’s proprietary process grows homogenous, refined cells from a single adipose tissue donor, enabling treatment for up to 70,000 patients from a single patient sample, significantly reducing costs, cell variability and increasing quality. The cell therapy induces a regenerative response through a complex mix of cytokines, hormones, and other factors, making it suitable for various debilitating conditions that require tissue repair and regeneration.
Its lead programme, BlueC-231, treats Erectile Dysfunction (ED), including severe ED, such as post-prostatectomy, by addressing the root causes of poor blood flow and nerve damage. An early proof-of-concept study with a single dose of autologous adipose MSCs has shown that 72% of the 11 men who had undergone prostatectomy and were continent but had had no erectile function for over a year, regained their ability to have an erection and perform sexually at six months. Subsequently, Blue Cell chose to take an allogenic approach, since the autologous cells are heterogenous and uncharacterised with regard to potency. Preclinical in vitro and in vivo data for BlueC-231 has shown angiogenesis and endothelial cell and nerve cell regrowth superior to autologous cells, giving confidence for proposed phase 1/2a studies.
It is estimated that 85 million men suffer from ED globally with 30% not responding to drug therapy. Additionally, a majority of the 490,000 men in the western world who undergo major prostate cancer surgery each year suffer severe ED a year after surgery, highlighting a growing unmet need.