STELLAR Trial
STELLAR Trial – treating fetal stroke
Are you pregnant with a baby that has been diagnosed with a fetal stroke?
What is the STELLAR TRIAL about?
The STELLAR Trial aims to test the feasibility and safety of autologous (babies own) umbilical cord blood collection and administration of the umbilical cord blood derived cells into young infants with antenatally diagnosed fetal stroke.
Who can participate?
- Newborn infants
- In whom fetal (antenatally diagnosed) ischemic or fetal haemorrhagic stroke is apparent
- No gestational cut off
What will the trial involve?
- The trial involves collection of recruited newborn’s umbilical cord blood at birth.
- The cord blood is tested, characterised and cryopreserved at industry partner, Cell Care Australia
- Infants with fetal stroke will have postnatal imaging to confirm associated brain injury.
- After release from Cell Care, cells are released to the Hudson Institute’s Cell Therapies Platform where they are thawed, washed and processed.
- The cells are then released to Monash Newborn.
- Then the infants own umbilical cord blood derived cells (autologous) are administered intravenously to the infant within 1-3 weeks. Two such infusions are done 5 -7 days apart.
What are the benefits of participating in the STELLAR Trial?
This is a safety and feasibility study. By participating you will be contributing to advancing this area of infant brain injury regenerative medicine.
Preclinical research has provided evidence that umbilical cord blood is neuroprotective, neuro-regenerative, immunomodulatory and have anti-inflammatory properties. This means these cells have the potential to reverse or mitigate some of the damage to the brain caused by antenatal injury (stroke).
FIND OUT MORE | First participant baby Chase featured here on 9News
How do I participate?
- Antenatally confirmed ischemic or haemorrhagic stroke
- Transfer care to Monash Health for delivery of infant
- Consent/recruit patient
- Umbilical cord blood collected at birth
- Successful collection is sent for testing and processing
- Autologous umbilical cord blood cell product administered intravenously to a clinically stable infant in the first few weeks of life (2 short admissions)
- Monitoring short term and long term neurodevelopmental follow up
Who do I contact?
If you are interested in participating or would like more information, please feel free to contact A/Prof Malhotra or Kirstyn Connelly.
Associate Professor Atul Malhotra | atul.malhotra@monash.edu or Kristyn Connelly | Kristyn.connelly@monash.edu
Lead researchers
Associate Professor Atul Malhotra
Honorary Clinical Associate, Neurodevelopment and Neuroprotection
Professor Suzanne Miller
Research Group Head, Neurodevelopment and Neuroprotection
Dr Courtney McDonald
Research Group Head, Cell Therapies and Neuroinflammation
Dr Abdul Razak
Cell Therapies and Neuroinflammation
Background research
Nguyen T, Purcell E, Smith MJ, Penny TR, Paton MCB, Zhou L, Jenkin G, Miller SL, McDonald CA, Malhotra A. Umbilical Cord Blood-Derived Cell Therapy for Perinatal Brain Injury: A Systematic Review & Meta-Analysis of Preclinical Studies. Int J Mol Sci. 2023 Feb 22;24(5):4351. doi: 10.3390/ijms24054351.
Zhou L, McDonald C, Yawno T, Jenkin G, Miller S, Malhotra A. Umbilical Cord Blood and Cord Tissue-Derived Cell Therapies for Neonatal Morbidities: Current Status and Future Challenges. Stem Cells Transl Med. 2022 Mar 17;11(2):135-145. doi: 10.1093/stcltm/szab024.
Zhou, Lindsay et al. “Feasibility of cord blood collection for autologous cell therapy applications in extremely preterm infants.” Cytotherapy vol. 25,5 (2023): 458-462. doi:10.1016/j.jcyt.2023.01.001