If stem cells are already classified as a medicinal product, the secretoma is not yet a drug but, if it were confirmed as safe and effective as the stem cells from which it derives, it could become so thanks to the process of transformation into powder, the result of Italian research, which makes it usable for inhalation or injectable administration. THEthe advantage is that it could be produced on a large scale at affordable costs and it would be more readily available for a large number of patients, even in developing countries, where there are no suitable resources and facilities for cell therapy.
Two studies are already active in China on healthy volunteers or with Covid-19, to evaluate their safety, in the first case, and efficacy in the second; and also in Italy experiments have been launched on the animal which hopefully will soon arrive in the clinic. “Although research is still limited, the secretoma would seem effective and above all safe: no side effects have ever been observed, even at high dosages – continues Torre – pFor example, he has a low risk of inducing embolisms after administration, has not induced the appearance of tumors, and appears to be immune-privileged just like the stem cells from which it derives. In other words, a secretome obtained from a non-histocompatible subject can also be used without activating an immune response “.
“The secretoma can be produced in the laboratory and, even in the absence of cells, it could regulate the immune and inflammatory response, stimulate the tissues and reduce the pulmonary fibrosis that results from the infection – he says Elia Bari, researcher of the Department of Pharmaceutical Sciences of the University of Pavia, creator of the new technology and author of the study published on Cells -, With the all-Italian technology that we have developed, it is also possible to transform it into a freeze-dried powder and pack it in ampoules as a drug. The prototypes of injectable or inhalable solutions already exist – adds Elia Bari – but if the secretome became a drug it could be produced on a large scale at costs comparable to those of traditional biological drugs and would be more easily available for many patients even in developing countries where cell therapy cannot be used due to lack of resources and structures “.
Meanwhile StemNet, the Federation of stem cell research associations, has declared itself in favor of the clinical use of cell therapies against Covid 19. “The mechanisms of effectiveness are not fully clarified and we cannot say with certainty the validity of this therapeutic approach, which seems to be attributable to anti-inflammatory and tissue damage protection activities – he intervenes Augusto Pessina, President of StemNet and member of the StaMeTec Coordinated Research Center of the University of Milan – However, taking into account the considerable safety of mesenchymal stem / stromal cells and their products – he adds – secretoma and extracellular vesicles, it is desirable to evaluate their targeted clinical use in seriously compromised and life threatening patients, necessarily following the current regulations of the phase I / II clinical trial or within compassionate uses “.
The Cells Study