One of the most important challenges of current medicine is the possibility of using mother cells in the treatment of different pathologies that, for now, are incurable, such as diabetes, the Parkinson, the heart disease ischemic, the Crohn's disease or spinal injuries. Now, after 17 years of investigation, a therapy 'made in Spain' Based on these, you can make life easier for 75,000 people in our country.
Its about first spanish treatment based on allogeneic stem cells (from outside the patient) approved in Europe, which was presented this Thursday at the Jiménez Díaz Foundation University Hospital. These come from donor adipose tissue, undergo a rigorous scientific process to be converted into a treatment to enhance the regenerative capacity of the organism and, through a surgical process, are applied to the patient.
This biotechnology project, developed by the biopharmacy company Takeda in Tres Cantos (Community of Madrid), has been able to attract foreign investment to Spain. Specifically, the benefited people -for now- for this scientific milestone are those who suffer complex perianal fistulas due to Crohn's disease, who can now access this newly approved therapy and will be funded by the Ministry of Health, Consumption and Social Welfare.
This type of abnormal connection between the inner surface of the anal canal affect more than 25% of patients With this pathology, some 75,000 throughout Spain, which until now had limited therapeutic options.
The people benefited – for now – by this scientific milestone are those who suffer complex perianal fistulas due to Crohn's disease
Damián García-Olmo, boss of the Department of General Surgery and digestive system of the Jiménez Díaz Foundation, and one of the main researchers of the therapy, says that “offers a novel and minimally invasive alternative for the treatment of patients with complex perianal fistulas that do not respond to currently available therapies and have so far had limited treatment options. "
A drug based on local immunity
The mechanism of action of this therapy is based on the restoration of local immunity and healing the damage of body tissues caused by inflammation. The marketing authorization is supported by the ADMIRE-CD phase III trial data, a study that showed that the therapy achieved significant statistical superiority. As these are cells from donors, and not from the patient himself, the verification of the quality and safety process has been key in its development.
The therapy – which has been developed in collaboration with academic institutions, public research entities and hospital centers – represents a milestone of Spanish science from which patients around the world will benefit. It is the first biotechnology project capable of attracting foreign investment and could position Spain on the global map of cell therapy.
Complications of Crohn's Disease
Disease Crohn affects about 1.1 million people in the European Union, with perianal fistulas being one of its most debilitating complications and it is estimated that it affects 25% of patients with this pathology. In Spain, the incidence of this disease and ulcerative colitis, has multiplied by 10 in the last 25 years and about 2,000 new cases are currently detected each year, with an increase of 2.5% annually.
Nowadays only very limited pharmacological treatments are available for the treatment of this abnormal connection, a situation that results in patients generally requiring surgical procedures on more than one occasion, associated with morbidity and with a greater risk of permanent stoma (a surgically created opening in the surface of the abdomen). The therapy manufactured in Tres Cantos represents a new treatment option for patients who are resistant to current approaches.