The patented inventions may have clinical applications in the field of ischaemic diseases, promoting the revascularization and regeneration of areas that have suffered ischaemia. Out of these applications, emphasis should be placed on treatments for diabetic foot and cardiac regeneration after a heart attack. The patented methodologies combine umbilical cord blood cells with endothelial progenitor cells and with lysophosphatidic acid (LPA), a bioactive lipid that performs an important role in a range of cell processes, in a fibrin gel.
It is estimated that 10-15% of diabetic patients will suffer chronic wounds over the course of their lifetime. There is currently no effective treatment for chronic wounds, which can lead to the amputation of a limb. This type of wound, typically ischaemic and neuroischaemic, affect over 340,000 patients in the United States and over 170 000 in Europe.
This new therapy may represent hope for a disease with serious consequences for the patient’s quality of life, and that does not yet have an effective treatment.
Prevalence of chronic wounds in diabetics
Heart disease is the main cause of death and disability in both industrialised and developing countries, and is responsible for approximately 40% of all human deaths. Many patients who survive a heart attack develop a chronic form of heart disease called congestive heart failure, which is associated with the progressive deterioration of the heart muscle, the formation of scar tissue and left ventricular dilatation and dysfunction. Patients with severe ischaemic heart failure have high morbidity and mortality rates, with heart transplants being the only final treatment option available.
Once the patent has been registered, the next step involves the development of all work necessary to make it possible to apply this methodology in clinical trials to assess its potential for treating these wounds.
Phases 1 and 2 of the clinical trial are planned over the next 3 years; this will be one of the first clinical trials using umbilical cord blood stem cells to be carried out in Europe.