Trial reportStem cells translational medicine2026
Five-year follow-up of phase II trial of autologous cord blood mononuclear cells for bronchopulmonary dysplasia prevention in very preterm infants.
Trial report in Stem cells translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02999373 (Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates), which is not on this map. Not yet cited in PubMed.
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Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
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8 authors.
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Abstract
backgroundWe previously performed a phase II clinical trial involving the intravenous infusion of autologous cord blood mononuclear cells (ACBMNCs) to prevent bronchopulmonary dysplasia in premature infants. We reported the outcomes before discharge and at 2-year follow-up of the enrolled infants. We have reported the developmental outcomes at the 5-year follow-up visit.
methodsWe evaluated the 5-year long-term outcomes of ACBMNCs infusion, including growth, respiratory, and neurodevelopmental outcomes, by interviewing the parents. Children's development was assessed using scores on the Chinese version of the Ages & Stages Questionnaires (ASQ), third edition (ASQ-3), completed by the parents or guardians. The primary outcome was the neurodevelopmental outcome. The secondary outcomes were growth and respiratory outcomes.
resultsIn terms of the primary endpoint, intravenously infused ACBMNCs significantly improved the scores of the fine motor and personal-social domains in the ASQ (P = .044 and P = .048, respectively). This study also showed high consistency between the motor index in the Bayley score at a 2-year follow-up with both gross and fine motor domain scores, as well as the language index with communication, problem-solving, and personal-social domain scores. Although pneumonia-related hospitalizations were similar between the two groups, the intervention group showed a lower possibility of nocturnal cough.
conclusionInfants who received intravenous ACBMNC infusion had better fine motor and personal-social abilities at 5 years than those in the control group. In addition to providing reassuring safety data, the study suggested longer-term neurodevelopmental benefits of ACBMNC intervention early in the NICU course. Further randomized placebo-controlled trials are essential to confirm these findings.
trial registrationThe trial was prospectively registered at ClinicalTrials.gov (NCT02999373), registered on December 21, 2016.
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