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| L-R: Dr Atul Malhotra, Professor Graham Jenkin Leaders of the study |
The Phase 1 Clinical Trial will involve a number of adult patients with severe to moderate pneumonia associated with COVID-19. The study will test the safety and efficacy of umbilical cord blood cells as a potential treatment for the coronavirus, which has infected almost five million people worldwide and caused more than 318,000 deaths.
About 24 patients will be recruited to the trial, which will take place at Monash Medical Centre in Clayton, Melbourne, between July and December 2020. The trial - involving clinicians and researchers from Monash Health and Monash University, and industry partner Cell Care Australia - is expected to take up to a year to complete.
Study co-leader Dr Atul Malhotra, a clinician scientist at Monash Health and Monash University, said cells from umbilical cord blood had been shown by his team and others to be anti-inflammatory, immunosuppressive and lodge in the lung—the primary site of the SARS CoV-2 infection - when given intravenously.
“Almost all serious cases of COVID-19 feature pneumonia,” Dr Malhotra said. “When SARS-CoV-2 enters the lungs, it triggers the body’s immune response to attack the virus, resulting in localised inflammation. Increasing evidence suggests that a subgroup of patients with severe COVID-19 may develop ‘cytokine storm syndrome’, an overreaction of the body’s immune system to the virus caused by localised production of inflammatory factors.
“The localised inflammatory response can result in hyper-inflammation, causing serious harm to affected organs, resulting in multi-organ failure and, if untreated, the cytokine storm syndrome, which is usually fatal.
“Our aim in this COVID trial is to prevent the hyper immune reaction leading to a cytokine storm before it progresses to acute respiratory distress syndrome,” said Dr Malhotra.
Dr Malhotra said this was the first study worldwide to use cord blood cells for COVID-19 related pneumonia.
The cells will be sourced from frozen units at Cell Care cord blood banks before being thawed, expanded and prepared for infusion to eligible patients.
Study co-leader Professor Graham Jenkin from Monash University said: “We want to prevent the progression of COVID-19 pneumonia in hospitalised patients before they deteriorate, leading to ARDS, and need a ventilator. If this is successful, this will lead to faster resolution of symptoms and discharge from hospital.”
Cell Care Australia CEO Brent Dennison said: “Cell Care is excited to support this important trial. It will be the first time that cells from expanded cord blood will be used outside of the transplant environment. We know the benefits that cord blood cellular treatment can have in other therapeutic areas, and we hope the properties of these cord blood cells will make a significant contribution to resolving the catastrophic effects of COVID-19.”
| FACT BOX / BACKGROUNDER – umbilical cord blood Umbilical cord blood is the blood that remains in a baby’s umbilical cord and placenta immediately after the baby is born and the umbilical cord has been clamped and cut. Cord blood contains a diverse mixture of important cells, including stem cells. Cord blood is a particularly rich source of haematopoietic stem cells (HSCs), which have the ability to create and heal our organs, blood and the immune system. Because of their “youth”, stem cells from umbilical cord blood are among the most flexible and potent in the body. Cord blood cell transfusions are now being used as an alternative to bone marrow transplants for life threatening conditions such as blood cancers, immune system and metabolic disorders and regenerative medicine applications. |
Story courtesy
Patty Barrett, Uptown Communications
patty@uptowncomms.com
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