Earlier this month, the National Health Surveillance Agency (Anvisa) approved a survey by the Pontifical Catholic University of Parana (PUCPR) to develop an advanced cellular therapeutic product to treat patients diagnosed with viral pneumonia caused by Covid-19. The clinical study, conducted with humans, evaluates the therapeutic potential of mesenchymal stem cells (MSC) in cases of virus-induced severe acute respiratory syndrome.
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While searching, they will be Select clinical indications, as The main adverse reactions Note that Special care for patients During and after use, as well as critical quality attributes of the product. The study will include 60 patients with moderate or severe viral pneumonia caused by the SARS-CoV-2 virus, to be confirmed by RT-PCR tests. To participate, patients must sign an Informed Consent Form (FICF).
Products are manufactured based on human cells or genes, and for clinical use in the population, they need proof of this Safety, efficacy and quality of products, besides the Anvisa health record. Use without agency permission constitutes a health and criminal offense, in addition to putting participants at risk.
Workers Hospital will be part of the study; Hospital de Clínicas affiliated with the Federal University of Paraná and McKenzie Evangelical University Hospital, all in Curitiba; In addition to the Spanish Hospital in Salvador; Hospital de Clínicas de Porto Alegre; and the National Institute of Cardiology in Rio de Janeiro.
Coordinated by the Professor at PUCPR College of Medicine, Paulo Roberto Slod BrofmannThe research is part of one of the projects approved in the institution’s internal public notice, launched in 2020, with the support of the Far South Regional Development Bank (BRDE).
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