Clinical trial NCT02999373: Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Official title: Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Premature
Neonatal Death
Keywords: prevention
Bronchopulmonary Dysplasia
preterm
cord blood mononuclear cells
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 62
Sex: ALL
Minimum age (years): 0
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).

This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.


Eligibility criteria: Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA \<32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.

Primary outcomes:
measure: bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
timeFrame: 36 weeks of postmenstrual age or the discharge
Secondary outcomes:
measure: number of patients with severe BPD in survivors
timeFrame: 36 weeks of postmenstrual age or the discharge
measure: number of patients died before discharge from hospital
timeFrame: before discharge from hospital
measure: the duration of mechanical ventilation
timeFrame: before discharge from hospital
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
affiliation: Guangdong Women and Children Hospital
name: Jie Yang, PHD
role: PRINCIPAL_INVESTIGATOR
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