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

ABSTRACT: INTRODUCTION:Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature infants. Umbilical cord blood-derived cells (UCBCs) are increasingly being evaluated for their neuroprotective and neuroreparative properties in preclinical and clinical studies. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants. METHODS AND ANALYSIS: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, UCB mononuclear cells will be harvested from the cord blood, characterised and stored. After excluding infants who have already suffered severe preterm brain injury, based on cranial ultrasounds in first week of life, preterm infants will be infused with autologous UCBCs via the intravenous route at a dose of 25-50?million UCBCs/kg body weight of live cells, with the cell number being the maximum available up to 50?million cells/kg. 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 cell administration. Secondary outcomes studied will include neonatal and neurodevelopmental morbidities till 2 years of life. Additional outcomes will include cell characteristics of all collected cord blood, and cytokine responses to cell administration in transplanted infants till 36 weeks' corrected age. ETHICS AND DISSEMINATION:Monash Health Human Research Ethics Committee approved this study in December 2019. Recruitment is to commence in July 2020 and is expected to take around 12 months. The findings of this study will be disseminated via peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER:ACTRN12619001637134.

SUBMITTER: Malhotra A

PROVIDER: S-EPMC7223148 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Malhotra Atul A Novak Iona I Miller Suzanne Lee SL Jenkin Graham G

BMJ open 20200511 5

<h4>Introduction</h4>Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature infants. Umbilical cord blood-derived cells (UCBCs) are increasingly being evaluated for their neuroprotective and neuroreparative properties in preclinical and clinical studies. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants.<h4>Methods and analysis</h4>A single centre safet ...[more]

PMID: 32398336

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Project description:ImportanceUmbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation.ObjectiveTo determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping.Design, setting, and participantsNoninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018.InterventionsParticipants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238).Main outcomes and measuresThe primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin.ResultsAmong 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, -2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002).Conclusions and relevanceIn this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions.Trial registrationClinicalTrials.gov Identifier: NCT03019367.

Dataset Information

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

Publications

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

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