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Cell therapy seeks answers for critical intubated by Covid-19

Filed: April 1 , 2020, 1:34 pm UTC by raquelserrano

Research raquelserrano 04/01/2020 Stem cells derived from fat indicated in Crohn's diseaseDamián García Olmo is a world leader in cell therapy.

"At the end of this week, or in the first days of next, if all goes well," a new clinical trial could begin that, despite the rush, joins all the scientific initiatives that seek not to give a truce to the damage that SARS-CoV-2 is producing: treating patients admitted to the ICU by coronavirus with what is already an active medicine, created and manufactured in Spain, fat-derived mesenchymal stem cells, known generically as darvadstrocel and authorized to fistulas associated with Crohn's disease. Thus, Damián García Olmo, head of the Department of General and Digestive Surgery of the Fundación Jiménez Díaz (FJD), in Madrid , awaits you., one of the greatest Spanish specialists in cell therapy, who from his job at this center is directly witnessing the disasters - in many cases uncontrollable, unpredictable and irreversible - that this new virus originates in the lungs of most of the patients requiring mechanical ventilation.

"The niche is intubated patients in whose lungs a cytokine 'inflammatory storm' occurs that leads to massive destruction due to the impossibility of gas exchange," says García Olmo, whose center - through the FJD Health Research Institute -, He is the promoter of this clinical trial, and its coordinator along with Bernat Soria, former Minister of Health, Professor at the Miguel Hernández University and a member of the Institute of Health and Biomedical Research, both in Alicante , who explains that, at this time, the The most serious problem is the one that is being experienced in the ICUs.

"The level of patients who enter them is grade VI, according to the WHO. That is our immediate 'target' and for this, based on the positive experience in other inflammatory diseases, -authorized by the Spanish Drug Agency (Aemps) in this case-, we will use this well-known active drug, tissue-derived mesenchymal stem cells adipose, for a new use. We start from the fact that Spain is a pioneer in the world in cell therapy, which, 'a priori', places us in a good position of response and that other international research groups have already started to develop. It is a worldwide movement. ”

Therapeutic procedure

After this initial approach - of which there are already some small experiences in China - and in little more than three days, García Olmo and Soria mobilized the Spanish Cell Therapy Network, as well as research groups from 5 universities and 8 hospitals in Spain , and to which others could be added progressively, to develop a project that has already been submitted to the Aemps and is in the approval phase.

The proposed plan, says García Olmo, is to inject the stem cells, manufactured in hospital clean rooms, intravenously, reaching the right atrium and from there, to the right ventricle. The drug will be distributed throughout the lung through the pulmonary artery.

If indeed the hypothesis raised in the clinical trial is correct, “we would have to see an improvement, in the sense that the intubation time of the patients in the ICUs decreases, as a complement to the rest of the treatments being administered. By reducing the inflammation, the gas exchange would not be so compromised and the needs for mechanical ventilation would be less, so the mortality in ICUs, which is currently very high and, unfortunately, unknown to us, would also decrease. This is the hypothesis because we do not want to raise false expectations and also because, and in the longer term, all the individual response factors will have to be taken into account ”.

Initially, the Spanish group has proposed to the Aemps the authorization of a very short pilot study, with 10 patients, to verify results that, in the case of a study carried out in China, specifically in Wuhan with 7 patients, has shown positive effects and It has led to the development of five other clinical trials in this city, as well as in Sanghai.

“With the initial analysis in these 10 patients, and in two or three weeks at the most, it will be observed if effects occur, thus being able to offer, and early, responses, because intubated patients die within the first 20 or 25 days. If the 'interim report' that we can carry out at that time is favorable, we would go on to treatment with 90 patients, whose informed consent, being in a critical situation, must come from the family or legal guardian, ”explains Soria.

Bernat Soria, Professor of Medicine at the University of Alicante.

This professor, an expert in cellular therapies and accustomed to the ins and outs of the operation of public administrations, knows that this trial, like the rest of those being considered in recent days, is moving "in an emergency context" in which science works against the clock in the fight against SARS-CoV-2.

"We are adjusting at all times to the regulations and the procedures with the Aemps are fast. While in a standardized situation the process of requesting a trial may take months, in such a context it is trying to solve in days. It is an extraordinary situation in which you have to give answers. And this involves a risk that the coordinators assume. ”

Ethical commitment to patients

According to Soria, in practice, a non-commercial trial is proposed to search for more solutions, which shares information with different groups -from the Spanish Network of Cell Therapy and others at an international level-, and in which administrations and scientists work, "with all speed. As a doctor, I must transmit an ethical commitment to patients, which leads to assuming risks that, under other conditions, would not be assumed ”. However, he stresses that the treatments carried out with this cell line in other pathologies have been shown to be safe and highlights another advantage: “Spain is a world pioneer in cell therapies, a very important fact because if we can confirm the data from the initial study with 10 patients "The next problem, in quotes, is going to be the production of cellular drugs, and Spain is in a good manufacturing and production situation."

So far, US research groups have proposed eight trials with cell therapy, with similar methodology, but not with the stem cells used by the groups in Spain. The stem cells approved in our country, derived from the experience of more than 20 years of the García Olmo group, are approved and indicated as anti-inflammatory medicine in Crohn's disease with successful results.

"In fistulas secondary to this disease, fat-derived mesenchymal stem cells have reduced this inflammation, a central problem in the pulmonary system of those affected by coronavirus in a critical situation. In all intubated patients in long-term ICUs, a non-classical phenomenon of inflammation is observed; it is an inflammatory 'storm' that causes massive destruction to the air exchange membrane, preventing extubation. This could be the scope of our action, our therapeutic niche, within a global therapeutic strategy, which is completely urgent, ”adds García Olmo.

If everything runs its course, in the next few days a Spanish clinical trial would begin with the only worldwide active cellular drug made in Spain that is already being used successfully in fistulas caused by Crohn's disease. coronavirus Off Raquel Serrano Off