The study, the broadest published to date in these conditions, has been published in The Lancet’s EClinical Medicine, after proving that the advanced treatment decreases mortality rates of critical patients with coronavirus from 85% to 15%. These are the first results of the BALMYS-19 project, co-led by professor from the Miguel Hernández University (UMH) and researcher at the Health Research Institute of Alicante (ISABIAL) Bernat Soria, together with professor Damián García-Olmo from the Jiménez Díaz foundation (Autonomous University of Madrid). Another six Spanish universities and six hospitals have taken part in the study.
Professor Soria began his research on the use of cellular therapy at the UMH and, afterwards, at the National University Hospital of Singapore during the Asian epidemic of SARS-1 in 2003 where he observed the intense pulmonary infiltrates in the biopsies of these patients. Unlike SARS-1, in the infection by coronavirus SARS-CoV-2, the clinical picture shows a depression of the immune system (lymphopenia), a widespread extreme inflammatory response, tissue damage, hypercoagulability and intense pulmonary distress that requires admission in the ICU. This advanced therapy is based on stem cells with regenerative, anti-inflammatory and immunoregulating properties, and is the first cell therapy for COVID-19 entirely developed and produced in Spain. During the pilot study, critical coronavirus patients were treated who did not respond to conventional cellular therapy treatment, composed of allogeneic mesenchymal stromal cells, in doses of one million cells per kilo of weight, in one or several doses. The results of its use in coronavirus patients admitted in ICUs were compared with the clinical evolution and mortality of similar cases.
According to the results obtained, the new cellular therapy does not cause adverse reactions, but does entail an overall clinical and radiological improvement. The mortality rate of patients decreased from 70-85% to 15% (two patients). A majority of people treated with the cellular therapy were extubated during the data collecting period. Their inflammation (C-reactive protein and ferritin), coagulation (D-dimer) and tissue damage (lactate dehydrogenase) markers decreased. Furthermore, it was verified that the drug did not decrease lymphocyte counts. In fact, the results show that the new treatment increases the presence of T lymphocytes (which directly attack the virus) and B lymphocytes (which synthesise antibodies).
Four researchers from Alicante province have taken part in the BALMYS-19 project: Clinical Medicine professor of the UMH Luis Manuel Hernández Blasco; Etelvina Andreu and Bernat Soria, from the Bioengineering Institute of the UMH; and José Miguel Sempere Ortells, from the University of Alicante. Furthermore, scientific and clinical staff from Madrid, Navarre, Murcia and Salamanca also took part. Said project and clinical trial was coordinated by professor Damián García Olmo from the Fundación Jiménez Díaz university hospital and professor Bernat Soria from the UMH (ISABIAL and Bioengineering Institute).
The authors of the study explain that cellular therapies, unlike other treatments, are “live drugs” and must be used by qualified medical staff, and produced by departments accredited by the Spanish Agency for Medicines and Health Products. Knowledge on the biological scientific foundations of these treatments, as well as of the physiology of the interaction between the drug and the host, are essential for their appropriate handling.
Bernat Soria also leads one of the four innovation and research projects in the fight against coronavirus at the UMH, chosen by the regional Valencian Government, as part of the #SúmateAlRetoContraElCovid-19 call, organised alongside the Valencian Innovation Agency (ACI).