After 18 years of work, Damián García-Olmo, head of the Surgery service of the Jiménez Díaz Foundation University Hospital in Madrid, has made the adventure that began in 2001 in a laboratory become, finally, a reality for patients.

The Ministry of Health will finance the first European medicine based on stem cells from donors; "a live drug , " says García-Olmo, who aims to improve the lives of patients with Crohn's disease who, due to the disorder, have developed a perianal fistula.

"It is the first time that a cell therapy from a donor makes the complete route that conventional drugs do", with the different phases of research and regulatory, "and reaches the market," says the researcher, who emphasizes that "it is about a success of the Spanish scientific system, "in which institutions such as the Autonomous University of Madrid, the Higher Council for Scientific Research, the Jiménez Díaz Foundation Hospital or the Takeda Pharmaceutical - which produces the drug - have collaborated, among others.

Approximately 40% of patients with Crohn's disease - an inflammatory bowel pathology - develop perianal fistulas , a problem that reduces their quality of life and for which, until now, there were no satisfactory solutions, explains García-Olmo. However, the new therapy - based on the use of mesenchymal stem cells from donor fat - has the ability to enhance the body's regenerative capacity, as well as reduce inflammation in the affected tissue, which contributes to healing. more effective and faster injury. The technique should be applied through a minimally invasive surgical process. "It means opening a door to the hope of the sick. We estimate that 60% of cases can be cured ," says the surgeon who, however, acknowledges that "the exact number of patients who can benefit is unknown."

As reported in a press conference Stefanie Granado, general director of Takeda Iberia, the therapy, which is manufactured in Spain and is already available in countries such as Germany, Austria, Finland, Israel or Iceland, will be financed in our country through the known modality as shared risk. "We have reached an agreement with the Ministry so that the financing is based on the results," said Granado. Thus, the payment of the medicine will be divided into two phases and the second payment will only be effective if the results in the patient are as expected.

The medicine, which has a life of 48 hours, requires the establishment of a rigorous supply chain that allows, from the Tres Cantos plant (Madrid), where it is produced, to arrive in time for any surgery in Europe. Obtaining mesenchymal cells , which expand 'in vitro' and are treated for therapeutic use, comes from voluntary donations of patients undergoing liposuction for aesthetic reasons.

But Darvadstrocel - the name given to the drug - could be used, in the future, for other indications, as García-Olmo has pointed out, who stressed that "it is the first indication of a new way to cure."

In his words, the approach could be used in many processes in which there is great inflammation, such as autoimmune inflammatory diseases, and scarring fails. " Trials are being done, for example, in rheumatoid arthritis, " says the specialist. But then remember that "you have to be very patient" because any new indication requires completing a long process of research and obtaining scientific evidence.

What began in 2001 as an idea to treat a patient with a very complicated injury, recalls the specialist, is already in the available market, "an achievement that has combined efforts from the hospital, academic and business fields."

For his part, Javier Maira, responsible for the Commercial and International Strategy Area of ​​the CSIC , recalled that this "global milestone" began with public funding and that the drug is based on two patents obtained by the CSIC and the Autonomous University of Madrid .

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