Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates

Phase 3

• Conditions: BPD
• Interventions: Biological: autologous cord blood mononuclear cells

• Registration Number: NCT05071638
• Lead Sponsor: Guangdong Women and Children Hospital

Brief Summary

This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD. The results of this trial will provide valuable clinical evidence for recommendations on the treatment of BPD in extremely preterm infants. Informed consent before birth is signed. In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups. The primary outcome is the rate of mortality or ratio of severe BPD at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include other common preterm complication rate and the number of hospitalizations due to pneumonia within 1 year of postmenstrual age.

Detailed Description

Study design and settings:

This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth. Umbilical cord blood was collected into a collection bag after delivery and labeled. The collection bag was placed in a 4° refrigerator for refrigeration and sent to the Guangdong Province umbilical cord blood Bank. ACBMNC will be separated and preserved with liquid nitrogen. The total content of umbilical cord blood cells, the number of mononuclear cells per ml and the volume before and after separation were provided immediately for the later calculation of the total volume of infusion. In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups. The primary outcome is the rate of mortality or ratio of severe BPD at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include other common preterm complication rate and the number of hospitalizations due to pneumonia within 1 year of postmenstrual age.

Trial treatment methods:

Informed consent before birth will be signed by the parents. All premature infants included in the study received standardized treatment after admission to the NICU. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment.

Study Timeline

• Study First Submitted: 2021-07-28
• Status Verified: 2021-10
• Study Start: 2021-10-01
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-08
• Last Update Posted: 2021-10-08
• Primary Completion: 2023-03-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• 1.born at study hospital;
• 2. singleton birth;
• 3. less than 28 weeks GA
• 4.Signed informed consent obtained;
• 5. Umbilical cord blood collection and testing qualified; 6.Diagnosed with BPD

Exclusion Criteria

• 1. with severe congenital abnormalities;
• 2.with maternal clinical chorioamnionitis
• 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACBMNC infusion group	autologous cord blood mononuclear cells	Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion. Cell dose for all patients was targeted at 5×107 cells per kilogram.

Primary Outcome Measures

Name	Time	Method
Rate of mortality or ratio of severe BPD	36 weeks of postmenstrual age or discharge home whichever comes first.	Rate of mortality or ratio of severe BPD at discharge or corrected gestational age at 36 weeks

Secondary Outcome Measures

Name	Time	Method
The number of hospitalizations	1 or 2 year of postmenstrual age	To compare the number of hospitalizations due to pneumonia, wheezing, asthma, nighttime cough, need for oxygen therapy, height, weight, nervous system development within 1 or 2 year of postmenstrual age.; Long-term outcome.
Incidence of other preterm complications	36 weeks of postmenstrual age or the discharge home whichever comes first.	Incidence of other preterm complications including intraventricular hemorrhage (IVH), periventricular leukomalacia(PVL), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), ventilation-associated pneumonia (VAP) and late onset sepsis (LOS)

Trial Locations

Locations (2)

Ren Xuejun; 🇨🇳 Dongguan, Guangdong, China

Jie Yang; 🇨🇳 Guangzhou, Guangdong, China