RecruitingPhase 1ACTRN12619001637134

Cord blood therapy in premature babies: a safety and feasibility study

Autologous transplantation of umbilical cord blood derived stem cells in extreme preterm infants: protocol for a safety and feasibility study

Sponsor

Monash Health

Enrollment

20 participants

Start Date

May 27, 2021

Study Type

Interventional

Conditions

preterm brain injury

Summary

Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature and extremely low birth weight infants. Umbilical cord blood derived stem cells (UCBCs) are being increasingly evaluated for their neuroprotective and neuroreparative properties. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants. Methods: A single centre safety and feasibility study in preterm babies born before 28 weeks gestation. Cord blood will be collected after birth and, if sufficient blood is obtained, UCBC will be harvested from the cord blood, characterised and stored. After excluding infants who have already suffered severe preterm brain injury, preterm infants will be infused with autologous UCBC via the intravenous route at a dose of between 25-50 million UCBCs/kg body weight. A minimum of 20 infants will be administered autologous UCBCs. Primary outcomes will include feasibility and safety. Feasibility will be determined by access to sufficient cord blood at collection and UCBCs following processing. Safety will be determined by lack of adverse events directly related to autologous UCBC administration in the first few days after administration. Secondary outcomes studied will include neonatal, and neurodevelopmental morbidities till 2 years of life.

Eligibility

Sex: Both males and femalesMin Age: 9 DayssMax Age: 16 Dayss

Plain Language Summary

Simplified for easier understanding

Being born very prematurely — before 28 weeks of pregnancy — is associated with significant risks of brain injury. The brain is still in a critical stage of development at this point, and complications during or after birth can cause lasting neurological damage. Researchers are exploring whether stem cells collected from a baby's own umbilical cord blood at birth might help protect and repair the developing brain. This early-phase study is testing whether it is safe and feasible to collect umbilical cord blood from extremely premature babies (born before 28 weeks), process those stem cells in a laboratory, and then give them back to the same baby intravenously in the first weeks of life. Because the cells come from the baby's own cord blood, there is no risk of rejection. The main goal at this stage is to check that the procedure can be done safely and that enough cells can be collected. Babies will be followed up to age 2 to track their development. Eligibility is for babies born before 28 weeks of gestation who do not already have severe brain injury (such as severe bleeding into the brain). As this study involves newborn babies, decisions about participation are made by parents or guardians on behalf of their baby.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Cord blood collection and processing: Minimum cord blood collection volume for inclusion in the trial will be 9 mLs. The collected cord blood (>9 mLs) will be processed according to standard cell processing operating procedures, aliquoted and cryopreserved. Storage and release: An aliquot containing sufficient numbers of UCBCs, according to weight of the preterm infant, required for early administration will be stored. Cell Care (Heatherton, VIC), a TGA accredited cord blood bank, will be responsible for collection, processing, storage of all samples and release of UCBC. Standard testing for impurities, cell viability and HLA matching of UCBC to the preterm infant’s HLA will be performed before release of UCBCs. Criteria for product release will include: free of microbial contamination after 7 days of culture, cell viability > 90% as determined by trypan blue exclusion at the time of cryopreservation, and HLA match from cord blood and infant sample. Thawing and infusion preparation: On the day of infusion, UCBCs will be retrieved from liquid nitrogen storage, and once product release criteria are met, frozen UCBC aliquot will be transported to Monash Health. Cells will be thawed using a pre-warmed heat block for approximately 2 minutes. The UCBCs will be washed with dextrose/ albumin and centrifuged at 350g for 5 minutes prior to resuspension in dextrose/ albumin at the final desired concentration. The UCBCs will be suspended at a concentration 10% greater than the desired concentration to allow for cell loss. Volume of cell infusion prepared will be around 10 mL/kg. A final cell viability will be done just prior to administration. Autologous transplantation of umbilical cord blood derived stem cells (intravenous) UCBCs will be administered ONCE intravenously (through a peripheral intravenous catheter) at a dose of 25-50 million viable cells/ kg body weight, 25 million/kg being the proposed minimum dose, and 50 million/kg being the maximum dose. UCBCs from autologous cord blood collection administered intravenously to infants, between D9 – D15 of life.

Locations(1)

VIC, Australia

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ACTRN12619001637134