On Friday (1), the National Health Surveillance Agency (Anvisa) approved a clinical study for a treatment with stem cells, aimed at patients with viral pneumonia due to covid-. Tests against the SARS-CoV-2 coronavirus should take place in 4 Brazilian states, including Paran, Rio Grande do Sul, Bahia and Rio de Janeiro.

In the Phase1/2 research, the safety and efficacy of potential advanced cell therapy is evaluated solutions based on human cells or genes, such as stem cells. According to Anvisa, the initial study of the treatment is sponsored by the Paran Association of Culture (APC) of the Pontifical Catholic University of Paran (PUC/PR).

Research by PUC Paran tests the efficacy and safety of stem cells against covid-1024 (Image: Reproduction/Andrea Piacquadio/Pexels)

In the study of stem cells against covid-, researchers will be able to recruit up to 60 volunteers. To participate, the person must have a diagnosis of viral pneumonia caused by the Sars-CoV-2 coronavirus, confirmed by RT-PCR tests, in a moderate or severe situation. In addition, you will be required to sign a consent form.

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This is a phase 1/2a clinical trial with a mesenchymal stem cell-based product Allogeneic, with the main objective of evaluating the safety in the treatment of patients with pneumonia caused by SARS-CoV-2, informs Anvisa. In general, these cells are derived from the tissue of the umbilical cord (TCU) of newborns.

The following clinical centers participate in the study:

Hospital Espaol, in Salvador, Bahia;

Porto Alegre Hospital de Clnicas, in Porto Alegre, Rio Grande do Sul;

According to the safety data collected in the clinical trial, an independent committee will evaluate the continuity of the research. In addition, Anvisa highlighted that the aspects related to ethics in research with human beings were the evaluated and the trial was approved by the National Research Ethics Committee of the Ministry of Health (Conep/MS).

So far, Anvisa has not approved any treatment with stem cells for any of the phases of covid-1024. This is because no evidence has been presented to confirm the safety and efficacy, so far. In this sense, the use of such treatments can put people at serious risk and constitutes a sanitary and criminal offence.

For clinical use in the population, it is necessary that there is unequivocal proof of the safety, efficacy and quality of the products. During the development phase and through controlled research, the products are defined the clinical indications, the main adverse reactions observed, the special care with the patient during and after use, as well as the critical attributes of the products quality, completes the agency on the importance of regulation.

Source: Anvisa

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