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

Phase 2

Completed

• Conditions: Bronchopulmonary Dysplasia; Premature; Neonatal Death
• Interventions: Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

• Registration Number: NCT02999373
• Lead Sponsor: Guangdong Women and Children Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-03
• Study First Submitted QC: 2016-12-17
• Study First Posted: 2016-12-21
• Study Start: 2018-07-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous cord blood mononuclear cells	Autologous Umbilical Cord Blood Mononuclear Cells Therapy	Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg

Primary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home	36 weeks of postmenstrual age or the discharge	bronchopulmonary dysplasia rate

Secondary Outcome Measures

Name	Time	Method
number of patients with severe BPD in survivors	36 weeks of postmenstrual age or the discharge	severe BPD in survivors
number of patients died before discharge from hospital	before discharge from hospital	mortality before discharge from hospital
the duration of mechanical ventilation	before discharge from hospital	Other outcomes

Trial Locations

Locations (1)

Jie Yang; 🇨🇳 Guangzhou, Guangdong, China