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

BPD Clinical Trial

Official title:

Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: a Non-Randomized Case-Control Trial Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05071638
• Other study ID #: Guangdong MCH
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2021
• Source: Guangdong Women and Children Hospital
• Contact: Zhuxiao Ren, MD
• Phone: +8613538984634
• Email: renzhx1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• BPD
• Bronchopulmonary Dysplasia

Intervention

Biological:
• autologous cord blood mononuclear cells
preterm neonates less than 28 weeks who suffer BPD and also stored cord blood are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg).

Locations

Country	Name	City	State
China	Ren Xuejun	Dongguan	Guangdong
China	Jie Yang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of mortality or ratio of severe BPD	Rate of mortality or ratio of severe BPD at discharge or corrected gestational age at 36 weeks	36 weeks of postmenstrual age or discharge home whichever comes first.
Secondary	Incidence of other preterm complications	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)	36 weeks of postmenstrual age or the discharge home whichever comes first.
Secondary	The number of hospitalizations	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.	1 or 2 year of postmenstrual age