The Dor Institute for Research and Education (IDOR), in collaboration with the Oswaldo Cruz Foundation (Fiocruz) and the Lung Research Laboratory of the Federal University of Rio de Janeiro (UFRJ), has initiated the country’s first clinical trial evaluating the efficacy of extracellular vesicles for the treatment of acute respiratory distress syndrome (ARDS). Extracellular vesicles are microscopic structures that function as part of a sophisticated cellular communication system. This condition is one of the main causes of admission to intensive care units and deaths in cases of respiratory infections.
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According to the researchers, with the new study, the country is placing itself at the forefront of a new generation of cell therapies, making it a pioneer in an approach that could revolutionize the treatment of serious lung diseases and other inflammatory and degenerative conditions.
“We are living a historic moment for Brazilian science with the advancement of safe and accessible biotechnological treatments, developed with distinction within Brazil with great potential for treating critical lung infections,” Bruno Solano, a researcher at the Dor Institute for Research and Education (IDOR), physician and project coordinator, said in a statement.
The study will evaluate the effectiveness of using extracellular vesicles derived from mesenchymal stem cells in treating this condition.
They transport proteins, lipids, and RNA fragments, including microRNAs, molecules that have the ability to regulate gene activity, and are essential in controlling inflammation and stimulating tissue repair. Building on this knowledge, Brazilian scientists sought to find a safe, scalable and technologically advanced way to convert these natural signals into biomedicines.
The vesicles used are derived from human umbilical cord mesenchymal stem cells and are grown under tightly controlled conditions at the IDOR Center for Biotechnology and Cell Therapy, located at the São Rafael Hospital, in El Salvador (BA). The phase 1/2 study will include 15 patients diagnosed with acute respiratory distress syndrome (ARDS) and admitted to intensive care units.
Acute respiratory distress syndrome is a serious and potentially fatal lung condition that causes respiratory failure due to widespread damage to the alveoli, leading to fluid buildup. It is often caused by conditions such as sepsis, pneumonia, severe COVID-19 or shock, and requires intensive treatment in an intensive care unit. Treatment focuses on treating the underlying cause and supporting respiratory function with mechanical ventilation.
The main aim of the research is to evaluate the safety, tolerability and potential therapeutic effects of intravenous infusion of extracellular vesicles. By acting systemically, the alveoli are expected to help control lung inflammation, reduce tissue damage and speed up the healing process.
Unlike stem cell therapies, which use living cells, extracellular vesicle therapies are acellular, or “cell-free,” an important innovation in the field of regenerative medicine. Among their main advantages are increased stability and uniformity of the product, allowing more controlled production with less variation between batches, as well as significantly reducing the risk of immune rejection.
Moreover, the greater stability of the vesicles greatly facilitates their storage and transport, enhancing their scalability and use in various clinical contexts.
The project, which was conceived as an emergency response to the COVID-19 pandemic, remains of great importance because ARDS can be caused by a variety of conditions, such as serious infections and trauma, and could become an important resource in the event of a new pandemic. The results of this study are expected to pave the way for expanding the research, with more centers and patients being included in phase III clinical trials.
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