Skip to main content
OpenTrials
Completed

NCT Number: NCT02999373

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Neonatal Death Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Premature Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

0 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jie Yang

Guangzhou, Guangdong, 511442, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Other

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

Primary outcomes

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

    Time frame: 36 weeks of postmenstrual age or the discharge

    bronchopulmonary dysplasia rate

Secondary outcomes

  1. number of patients with severe BPD in survivors

    Time frame: 36 weeks of postmenstrual age or the discharge

    severe BPD in survivors

  2. number of patients died before discharge from hospital

    Time frame: before discharge from hospital

    mortality before discharge from hospital

  3. the duration of mechanical ventilation

    Time frame: before discharge from hospital

    Other outcomes

Sponsors and collaborators

Lead sponsor

Guangdong Women and Children Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2016
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.