Neonatologist and clinician-scientist Associate Professor Atul Malhotra from The Ritchie Centre, the School of Clinical Sciences at Monash Health, and Monash Children's Hospital, has been awarded a Fulbright Professional Coral Sea Scholarship to support the US implementation of an umbilical cord blood (UCB) cell therapies clinical trial for extremely preterm babies.
The 'Autologous cord blood-derived cell therapy for extremely preterm infants: An international, multicentre randomised controlled trial (CORD-CELL RCT)' trial aims to evaluate the effectiveness of using extremely preterm infants' own UCB cells to improve survival rates and developmental outcomes.
The trial will be conducted at multiple clinical locations across Australia, Singapore, Canada and the United States.
More than 15 million babies are born preterm (less than 37 weeks of gestation) every year around the world.
Preterm babies are at risk of short-term and long-term complications, with those born extremely premature (less than 28 weeks of gestation) at the highest risk. Complications can include injuries to their lungs, brain, heart and other organs. Brain injury is especially common in extremely preterm babies, with outcomes including developmental delays, cerebral palsy, behavioural and cognitive issues.
UCB therapies for neuroprotection and therapy
While survival rates have been improving over the last few decades, the incidence and severity of preterm brain injury continue to be high. There is an unmet need to develop neuroprotective and therapeutic strategies for these vulnerable babies, and cell therapies and stem cells are one such frontier of investigation.
This work builds on the STELLAR trial, a world-first collaboration between Hudson Institute, Monash University and Monash Health, that looked at the safety and feasibility of using a baby's own umbilical cord blood stem cells as a treatment for antenatally diagnosed fetal stroke.
This trial involved collection of umbilical cord blood at birth, which was then tested, characterised and cryopreserved by Cell Care Australia, before being thawed, washed and processed by Hudson Institute's Cell Therapies Platform, then released to Monash Newborn for reintroduction into affected babies.
The STELLAR trial showed that re-infusion of a baby's own cord blood-derived cells in extremely preterm infants in the second week of life was feasible and safe. The next step is to test this innovation in the CORD-CELL trial to assess the efficacy of this intervention to prevent neurodisability in these babies – which is where support from the Fulbright Scholarship comes in.
The Scholarship will see A/Prof Malhotra spend 3-4 months engaging with key US trial stakeholders and assisting with trial setup at locations including Houston, Boston, Birmingham, Gainesville and others.
A/Prof Malhotra, who is also Co-Director of the Newborn Cell Therapies Group, is thankful to have received the Fulbright Scholarship.
"I am looking forward to working closely with my research collaborators in the United States to establish our American clinical sites, and work on other neonatal cell therapy research ideas," he said.
"Ultimately, my hope is that our research will provide the evidence we need to develop and deliver cell therapies that improve the lifelong health outcomes of our most vulnerable babies."
