Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

Guangdong Women and Children Hospital62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Bronchopulmonary Dysplasia Premature Neonatal Death

Interventions

Autologous Umbilical Cord Blood Mononuclear Cells TherapyOTHER

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection

Eligibility

Sex: ALLMin age: 0 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Jie Yang

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home

bronchopulmonary dysplasia rate

Time frame: 36 weeks of postmenstrual age or the discharge

Secondary Outcomes

number of patients with severe BPD in survivors

severe BPD in survivors

Time frame: 36 weeks of postmenstrual age or the discharge

number of patients died before discharge from hospital

mortality before discharge from hospital

Time frame: before discharge from hospital

the duration of mechanical ventilation

Other outcomes

Time frame: before discharge from hospital

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.