A breakthrough stem cell therapy to cure Erectile Dysfunction

Blue Cells

The Blue Cells are stem cells that will be available as an ‘over the counter’ allogenic stem cell therapy. The product will work as curative treatment of erectile dysfunction. The Blue Cells work by promoting angiogenesis, repairing the endothelium, vascular smooth muscle, and neurons but also by inhibiting inflammation. After prostatectomy, erectile dysfunction often occurs when the penile nerves suffer from nerve damage, which leads to reduced release of nitric oxide and inability to achieve an erection. Lack of nocturnal erections also causes fibrosis of penile tissue and apoptosis of endothelial cells in the cavernous sinuses, resulting in permanent erectile dysfunction. Improving blood supply to the penile area can help the regeneration and function in the area.  

In a previous phase I clinical trial, 8 out of 11 men who received autologous adipose derived stem cell treatment regained erectile function completely, even though the patients had erectile dysfunction for one year after prostatectomy and had no effect from PDE-5 inhibitors, like Viagra (Haahr, M et al. EBioMedicine 2016; 1-year follow-up: Haahr, M et al. Urology 2018,5:204). 

Our studies show that the Blue Cells hold the potential to restore penile erectile function similarly to, or even better than, the autologous adipose derived stem cells used in the clinical trial.  

The autologous adipose derived stem cells require liposuction and an on-site autologous adipose derived stem cells isolation. Furthermore, it is inconvenient and painful to the patient. The development of an allogeneic cell therapy will overcome the need for liposuction and reduce variation in treatments. We have improved the isolation and culture conditions of adipose derived stem cells, to obtain a homogeneous and highly potent stem cell population for treatment use. Our multiple in vitro, ex vivo and in vivo assays evaluate the angiogenic potency of the cultured adipose derived stem cells. Thus, our proprietary cell culture conditions generate stem cells with improved angiogenic capabilities. These Blue Cells are the product we are working on making available to patients worldwide as an ‘over the counter’ product. Industry and biotech partners will secure the further development of Blue Cells as a GMP produced allogeneic product to enable clinical trial evaluation and obtain EMA and FDA approval to enter the market.