What are Blue Cells
Blue Cells are an off-the-shelf, allogeneic stem-cell therapy designed to harness angiogenesis and nerve regeneration as a curative approach for challenging conditions. By releasing angiogenic factors like VEGF and key neurotrophic proteins, Blue Cells drive new blood-vessel formation and support nerve repair. Our lead program, BlueC-231, is focused on severe erectile dysfunction (ED), while additional indications—such as pulmonary arterial hypertension (PAH)—are under exploration.
In ED, Blue Cells orchestrate healing by stimulating blood-vessel growth, repairing endothelial and smooth-muscle cells, and restoring neuronal connections, all while countering inflammation. Together, these effects return penile tissue to a healthy, functional state capable of achieving and maintaining an erection.
Men who undergo prostatectomy for prostate cancer frequently suffer nerve injury that impairs nitric oxide release and leads to erectile difficulties. Over time, the absence of nocturnal erections promotes tissue fibrosis and endothelial cell loss, causing permanent ED. By enhancing blood flow in the penile region, Blue Cells support both tissue regeneration and the return of function.
Enhancing penile blood flow, this process ultimately restores erectile function.
In a rat model of post-prostatectomy injury, we demonstrated that these cells repair nerve damage.
Preclinically, we’ve demonstrated that Blue Cells repair nerve damage in a rat model that mimics post-prostatectomy injury. Clinically, in a Phase I autologous trial, eight of eleven urine-continent men regained full erectile function after enduring ED for a year and showing no response to PDE-5 inhibitors (e.g., Viagra). These outcomes suggest that Blue Cells may match—or even surpass—the restorative power of autologous adipose-derived stem cells in reviving erectile function.
What are Blue Cells
Blue Cells are an ‘off-the-shelf’ allogeneic stem cell therapy being developed as a potentially curative solution for diseases where angiogenesis and nerve regeneration are beneficial.
Blue Cells stimulate new vessel growth through secretion of angiogenic factors, such as VEGF and others, and also stimulate nerve regeneration by secretion of additional neurotrophic factors. Blue Cell is currently developing its lead program, BlueC-231, for the treatment of severe Erectile Dysfunction (ED), with other indications such as Pulmonary Arterial Hypertension (PAH) under investigation.
In erectile dysfunction (ED) Blue Cells work mainly by promoting angiogenesis and repairing the endothelium, vascular smooth muscle, and neurons. They also work by inhibiting inflammation. All these processes work to return the penis to its normal healthy state, able to achieve and maintain an erection.
A particular patient population that our Blue Cells have the potential to help, is men who have undergone prostatectomy for prostate cancer. Prostatectomy often causes damage to penile nerves, leading to reduced release of nitric oxide and inability to achieve an erection. A subsequent lack of nocturnal erections can then cause 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.
This increases the blood flow to the penis, eventually leading to regaining of erectile function.
We have shown that these cells heal nerve damage in a rat model resembling human prostatectomy.
In a previous phase I clinical trial, 8 out of 11 urine continent 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 received no benefit from PDE-5 inhibitors like Viagra.
Our studies show that Blue Cells hold the potential to restore penile erectile function as well as, or even better than, the autologous adipose-derived stem cells used in the clinical trial referred to above.
Blue Cells' approach
Autologous adipose-derived stem-cell treatment involves liposuction and on-site cell isolation, making the procedure inconvenient and uncomfortable for patients. In contrast, our allogeneic therapy eliminates the liposuction step and ensures more consistent outcomes across treatments.
By optimizing both the isolation process and our proprietary culture conditions for adipose-derived stem cells, we’ve significantly boosted their angiogenic potency. A comprehensive series of in vitro, ex vivo, and in vivo assays confirms that these tailored culture methods produce stem cells with superior blood-vessel-forming ability.
Blue Cells represent our off-the-shelf solution aimed at global patient access. By partnering with industry and biotech leaders, we’ll advance GMP manufacturing of this allogeneic therapy, support its clinical-trial progression, and pursue EMA and FDA approvals for market launch.
Blue Cells' approach
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 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. Our multiple in vitro, ex vivo and in vivo assays have evaluated the angiogenic potency of the cultured adipose derived stem cells. Thus, our proprietary cell culture conditions generate stem cells with improved angiogenic capabilities.