Clinical improvement in COVID patients with mechanical ventilation has been shown using cellular therapy
- Clinical improvement in COVID patients with mechanical ventilation has been shown using cellular therapy
Identification of effective treatments in severe cases of COVID-19 requiring mechanical ventilation represents an unmet medical need. The Lancet's EClinical Medicine published the broadest to date study that shown an 85% to 15% decrease in mortality rates of critical patients with coronavirus infection.
Due to anti-inflammatory and immunomodulatory effects of mesenchymal stem cells (MSC) MSC-based therapy medical products are approved for some inflammatory diseases, as Crohn's disease and graft-versus-host disease. There is pre-clinical evidence that intravenous administration of MSC in respiratory virus infection models might reduce lung damage. But there is a huge lack of data. A number of clinical trials are already registered in different databases, but no series of patients have been published so far. This paper presents the first results of the BALMYS-19 project, performed by collaboration of researchers from Miguel Hernández University (UMH), Health Research Institute of Alicante (ISABIAL) and Autonomous University of Madrid. Moreover, another six Spanish universities and six hospitals have taken part in the study.
Professor Soria from ISABIAL began his research on the use of cellular therapy at the UMH and, afterwards, at the National University Hospital of Singapore during the SARS-1 Asian epidemic in 2003. That days, he observed the intense pulmonary infiltrates in the biopsies of SARS patients. In contrast, clinical picture in the SARS-CoV-2 infection shows a depression of the immune system, a widespread extreme inflammatory response, tissue damage, hypercoagulability and intense pulmonary distress that requires admission in the ICU. This MSC-based advanced therapy is the first cell therapy for COVID-19 entirely developed and produced in Spain. During the study, critical coronavirus patients under invasive mechanical ventilation who had received previous antiviral and/or anti-inflammatory treatments were treated with allogeneic adipose-tissue derived MSC, in doses of about one million cells per kilo of body weight, in one or several doses. First dose of AT-MSC was administered at a median of 7 days after mechanical ventilation. Potential adverse effects related to cell infusion and clinical outcome were assessed. 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). Clinical improvement was observed in nine patients (70%). A 7 patients (more than 50%) treated with the cellular therapy were extubated during the data collecting period. Their levels of inflammation (C-reactive protein and ferritin), coagulation (D-dimer) and tissue damage (lactate dehydrogenase) markers decreased, as well, as a lymphocytes count increased. Particularly in those patients with clinical improvement, the results show the increase in the presence of T lymphocytes (which directly attack the virus) and B lymphocytes (which synthesize antibodies).
The authors of the study explain that, unlike other treatments, cellular therapies are "live" and must be used by qualified medical staff, and produced by accredited departments. The appropriate handling of these treatments requires the fundamental understanding of the biological principles of these treatments, as well as of the physiology of the interaction between the drug and the host.