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

NCT05071638 | Unknown Phase 3 DMC

• 1 other identifier: Guangdong MCH
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

BPD

Keywords

Autologous cord blood mononuclear cells; bronchopulmonary dysplasia; extremely preterm neonates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of other preterm complications

  36 weeks of postmenstrual age or the discharge home whichever comes first.

• The number of hospitalizations

  1 or 2 year of postmenstrual age

Study Arms (2)

ACBMNC infusion group

EXPERIMENTAL

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.

Biological: autologous cord blood mononuclear cells

control group

NO INTERVENTION

The control group received standardized treatment without special treatment.

Interventions

autologous cord blood mononuclear cells BIOLOGICAL

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).

ACBMNC infusion group

Eligibility Criteria

• Age: Up to 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \. with severe congenital abnormalities;
• with maternal clinical chorioamnionitis
• \. 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.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (2)

Ren Xuejun

Dongguan, Guangdong, China

Location

Jie Yang

Guangzhou, Guangdong, 511400, China

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jie Yang, PhD

  Guangdong Women and Children Hospital

  STUDY CHAIR

Central Study Contacts

Zhuxiao Ren, MD

CONTACT

+8613538984634; renzhx1990@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: A hospital ethics committee reviewed the study data during the trials. None of them were involved in the study or aware of the treatment-group assignments of the infants. Nurses and physicians staff conducted the infusion are not aware of the treatment assignment, and these individuals had no contact with the staff who collected and analyzed the patients data. The parents are aware of the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.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.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: October 8, 2021
• Study Start: October 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: all time
• Access Criteria: all

Locations

CN (2)