Texas Heart Institute to participate in a study to treat ARDS in hospitalized COVID-19 patients

Texas Heart Institute (THI) has been selected as one of up to 60 sites in the world to participate in an international investigative study seeking to aid COVID-19 patients who develop acute respiratory distress syndrome (ARDS). Dr. Emerson Perin, a globally recognized cardiologist known for his work developing stem cell therapies for cardiovascular diseases, is serving as the study's principal investigator at Texas Heart Institute.

Sponsored by the Australian regenerative medicine company Mesoblast, the study will commence locally through the Cardiothoracic Surgical Trials Network at Texas Heart Institute in December 2020. As part of the study - which will focus on the sickest of patients - participating ICU patients with ARDS due to COVID-19 will be randomized to receive intravenous infusions of allogeneic mesenchymal stromal cell-based therapy or placebo in addition to maximal care.

According to the CDC, as many as 85% of ICU patients suffer from ARDS, and 20 to 42% of patients hospitalized with COVID-19 develop the complication. Over 40% of ICU patients diagnosed with ARDS die - with some studies indicating a number as high as 72% - and those who survive the complication spend 10-13 days in the hospital on average.

Texas Heart Institute is eager to participate in a study that has tremendous potential to alleviate serious COVID-19 complications in the very sick. My colleagues and I have been working on cell therapy for the heart for the past 20 years, and in that time, we have seen stem cell treatments significantly improve pulmonary function. Essentially, the lungs work as a filter, and when stem cells are administered intravenously, they end up in the lungs. Taking what we have learned from the data accrued from countless heart patients over the years, we are applying it to COVID-19 patients in order to utilize the power of cells to mitigate inflammation in the lungs in individuals who have few other treatment options."

Dr. Emerson Perin, study's principal investigator, Texas Heart Institute

Mesoblast's remestemcel-L, an intravenous (IV) infusion of allogeneic mesenchymal stem cells (MSCs), has previously been administered in other clinical settings with positive results. At New York's Mount Sinai hospital, investigators observed an 83% survival rate in patients with COVID-19 infection who depended on ventilator support after treatment with remestemcel-L under emergency compassionate use. Within a median of ten days of treatment, 75% no longer needed ventilator support. Soon thereafter, 7 of the 12 patients were discharged from the hospital. The Texas Heart Institute will now utilize the treatment as part of the continuing global study, and Dr. Perin is optimistic that promising results will persist. "It is very important to have options for patients who are running out of lifelines in the fight against COVID-19. Individuals have responded well to this treatment, and Texas Heart Institute is poised to help save lives of those who are running out of hope," he concluded.

Patients may be eligible if they meet the following criteria:

1. 18 years or older
2. Patient has SARS-COV 2 confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) assay or another diagnostic test
3. Patient requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by criteria adapted from the Berlin criteria, including confirmed COVID on chest radiograph or computerized tomographic (CT) scan.

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