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Investigational new drug may be beneficial in treating severe COVID-19

4 May 2020
Appeared in BioNews 1045

A novel stem cell therapy may play a part in improving the survival rate of ventilator-dependent COVID-19 patients.

Twelve COVID-19 patients at Mount Sinai Hospital in New York were treated with a new type of stem cell therapy, resulting in a survival rate of 83 percent, significantly higher than the 12 percent survival rate for similar untreated patients.

Dr Keren Osman who led the team Mount Sinai Hospital, New York told CBS News: 'What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better'.

Ryoncil (remestemcel-L) comprises culture-expanded mesenchymal stem cells (MSCs): rare cells that secrete factors that promote tissue repair and modulate an immune response.

The initial trial of Ryoncil with COVID-19 patients included two intravenous infusions of the drug over five days. Ten of the total 12 patients were able to come off ventilators after treatment. All patients had received other experimental therapies before receiving Ryoncil.

Dr Osman said 'we don't know if the ten people taken off ventilators would not have recovered if they had not been given the stem cell treatment and we would never dare to claim that it was related to the cells… A randomised controlled trial would be the only way to make a true comparison.'

A 300-person randomised, controlled clinical trial is now planned to determine the safety and efficacy of Ryoncil in the treatment of COVID-19 patients suffering from acute respiratory distress syndrome (ARDS), which results when the patient is unable to get enough oxygen and usually requires the use of a ventilator.

The overreaction of the immune system responsible for these effects is often termed a 'cytokine storm', where the systemic response to destroy the virus ends up damaging the infected lung tissue. Cytokines are small proteins released from certain cells in the immune system and play a role in cell signalling. Therapeutic use of Ryoncil is thought to down-regulate pro-inflammatory cytokine production and stimulate increased production of anti-inflammatory cytokines.

Ryoncil is currently under review by the US Food and Drug Administration (FDA) for the treatment of acute graft versus host disease and other rare diseases. The drug has been evaluated through several clinical trials, totalling over 1100 patients, including evidence of improved lung function in patients with similar biomarkers to COVID-19 patients with ARDS.

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