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.
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
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.
These Blue Cells are the product we are working on making available to patients worldwide as an ‘off-the-shelf’ 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.
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.