Regenerative medicine is one of the fastest growing biomedical industries in the world and represents a new paradigm in healthcare. To date, the vast majority of treatments for chronic and life-threatening diseases have been addressing the symptoms, not treating the underlying disease. Regenerative Medicine is changing this by engineering, growing, and regenerating tissues and organs using biological processes similar to those normally found in nature, in order to replace or substitute dead or diseased cells/tissues.
The lack of progress in treating CNS injury and neurodegeneration stems from the difficulty in rebuilding and reconnecting neurons in the central nervous system (CNS), and this in turn is linked to the limitations of current drug and stem cell treatments.
There has been much confusion in the stem cell field, as in reality none of the stem cells in development today readily connect and functionally graft to the patient’s existing nervous system. Instead they only provide a “by-stander effect”, i.e. they release cytokines into their surroundings. In other words: “the fertilizer, not the seeds”.
Fortuna provides both the fertilizer and the seeds.
Autologous cells are the patient’s own cells, while Allogeneic cells are from a donor. Autologous cells readily connect with and naturally work together with the patient’s existing cells and organs. Allogeneic cells do not, and require heavy immune-suppression. Traditionally, Allogeneic cells have been shown to be significantly easier and cheaper to manufacture, which is why most companies work with these cells. Many of the allogeneic cells come from either embryonic or fetal sources. (Fortuna manufactures autologous cells, and thus does not use embryonic or fetal cells or other materials).
Potent autologous stem cell sources – before Fortuna Fix – did not include the vital and necessary neural stem cells needed for treating neurodegenerative diseases. This is due to the risks of doing a brain biopsy to collect these cells; furthermore in adults this number is already too low with limited potency for effective cell therapy. As a result, the only autologous stem cell sources under development have traditionally been mesenchymal (bone, cartilage and fat) stem cells and hematopoietic (blood) stem cells that are easy to obtain from patients but have limited effects on the nervous system. In the most recent evolution in this field, induced Pluripotent Stem cells (iPS cells) were identified as strong candidates for providing a method of producing an autologous neural stem cell therapy, but their very high reprogramming cost combined with a slow and difficult manufacturing process as well as their questionable safety profile have dampened the enthusiasm.
Fortuna’s technology portfolio and products will Fix this.