Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates: a Placebo-controlled Randomized Multicenter Trial

Who is this study for? Patients with Severe Bronchopulmonary Dysplasia
What treatments are being studied? Autologous Cord Blood Mononuclear Cells
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death. The results of this trial will provide valuable clinical evidence for recommendations on the management of BPD in extremely preterm infants. In this prospective, randomized controlled double-blind multi-center clinical trial, 140 extremely preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (targeted dose of 5×107cells/kg but no less than 1×107cells/kg) or placebo ( normal saline) within 24 hours after birth in a 1:1 ratio using a central randomization system. The primary outcome is survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include mortality rate, BPD severity, other common preterm complication rate, respiratory support duration, the length and cost of hospitalization and long term outcomes after two years follow up post infusion.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• Infants fulfilling all the following inclusion criteria will be enrolled in this trial: 1. born at study hospital; 2. singleton birth; 3. less than 28 weeks GA 4.Signed informed consent obtained; 5. had available umbilical cord blood (UCB).

Locations
Other Locations
China
Ren Xuejun
RECRUITING
Dongguan
Jie Yang
RECRUITING
Guangzhou
Contact Information
Primary
zhuxiao Ren, MD
renzhx1990@163.com
+8613538984634
Time Frame
Start Date: 2020-06-20
Estimated Completion Date: 2023-12-31
Participants
Target number of participants: 140
Treatments
Experimental: ACBMNC infusion group
Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after birth. Cell dose for all patients was targeted at 5×107 cells per kilogram.
Placebo_comparator: control group
Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume.
Sponsors
Collaborators: Dongguan Women and Children Hospital, Shunde Women and Children Hospital, Huizhou second Women and Children Hospital, Huangdu Distric Women and Children Hospital, Hexian Memorial Affiliated Hospital of Southern Medical University, Guangdong Cord Blood Bank, Longgang Distric Women and Children Hospital,Shenzhen, Heyuan Women and Children Hospital, Foshan Fuxing Chancheng Central Hospital, Huizhou first Women and Children Hospital, Guangzhou Huadu Women and Children Hospital, BoAi Hospital of Zhongshan, Foshan Women's and Children's Hospital
Leads: Guangdong Women and Children Hospital

This content was sourced from clinicaltrials.gov