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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bronchopulmonary Dysplasia, Premature, Neonatal Death

Intervention / Treatment
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* Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous cord blood mononuclear cells<br>Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg | Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy<br>* Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection<br>|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home | bronchopulmonary dysplasia rate | 36 weeks of postmenstrual age or the discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with severe BPD in survivors | severe BPD in survivors | 36 weeks of postmenstrual age or the discharge | 
| number of patients died before discharge from hospital | mortality before discharge from hospital | before discharge from hospital | 
| the duration of mechanical ventilation | Other outcomes | before discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, Bronchopulmonary Dysplasia, preterm, cord blood mononuclear cells