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Safety of Autologous Cord Blood Cells for Preterms: A Descriptive Study
Jie Yang1, Zhuxiao Ren1, Chunyi Zhang1
1Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou, China.
Insights
Fresh autologous umbilical cord blood (UCB) cell infusion is safe for preterm infants. This study found no adverse effects, with all infants surviving and showing reduced complications like bronchopulmonary dysplasia.
Area of Science:
- Regenerative medicine
- Neonatal care
- Stem cell therapy
Background:
- Preterm birth complications are a leading cause of mortality in children under 5.
- Survivors often face lifelong disabilities, including cognitive and developmental impairments.
- Umbilical cord blood (UCB) cells are being explored for treating neonatal conditions like hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).
Purpose of the Study:
- To evaluate the safety of infusing autologous, volume- and red blood cell- (RBC-) reduced, noncryopreserved UCB cells into preterm infants.
- To assess the feasibility of using fresh UCB cells in neonatal intensive care.
Main Methods:
- A phase I, open-label, single-arm, single-center trial was conducted.
- 15 preterm infants (<37 weeks gestational age) received UCB cell infusion (5 × 10⁷ cells/kg) within 8 hours of birth.
- UCB cell characteristics, vital signs, laboratory data, and clinical outcomes including mortality and preterm complications were monitored.
Main Results:
- Processed UCB cells met quality standards for volume, cell number, CD34+ cells, colony-forming units (CFU-GM), and vitality.
- No adverse effects were observed during or after the infusion.
- All 15 infants survived, with reduced incidence of BPD, necrotizing enterocolitis (NEC), and retinopathy of prematurity (ROP).
Conclusions:
- The collection, preparation, and infusion of fresh autologous UCB cells are feasible and safe for preterm infants.
- This approach shows promise in reducing severe neonatal complications.
- Further adequately powered randomized controlled studies are warranted to confirm efficacy.
Background:
Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).
Objective:
To assess the safety of autologous, volume- and red blood cell- (RBC-) reduced, noncryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Method:
This study was a phase I, open-label, single-arm, single-center trial to evaluate the safety of autologous, volume- and RBC-reduced, noncryopreserved UCB cell (5 × 107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and postinfusion vital signs, and laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded.
Results:
After processing, (22.67 ± 4.05) ml UCB cells in volume, (2.67 ± 2.00) × 108 cells in number, with (22.67 ± 4.05) × 106 CD34+, (3.72 ± 3.25) × 105 colony forming cells (CFU-GM), and (99.7 ± 0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30 ± 23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) was observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), 5/15 (33.3%) infants with ventilation-associated pneumonia, and 10/15 (66.67%) with anemia, respectively.
Conclusions:
Collection, preparation, and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.
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