Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates

Safety Issues Clinical Trial

Official title: Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates

Status Recruiting

Clinical Trial Summary

To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants

Clinical Trial Description

This is a Phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg, 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.

1. Demographic Data and Baseline Characteristics of the Studied Groups were collected:

• Gestational age (weeks)

• Birth weight (g)

• gender

• Cesarean section delivery

• Antenatal steroids

• Prolonged rupture of membrane

• Multiple pregnancies

• APGAR score at 5 minutes

• Thrombocytopenia before intervention

• CRP before intervention (mg/L)

• TNF-α(tumor necrosis factor α ) before intervention (pg/mL)

2. Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously

3. Autologous cord blood mononuclear cells doses is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，and with same volume of 0.9% sodium chloride as placebo.

4. The following are monitored at 3、7、14、21 days after birth:

• mortality, incidence of sepsis, neonatal respiratory distress syndrome (NRDS), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), Hypoxic Ischemic Encephalopathy (HIE), anaemia, thrombocytopenia, neutrophil,TBNK cells subgroup, before hospital discharge.

5. Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth. ;

Related Conditions & MeSH terms

• Effect of Drugs
• Neonatal Death
• Perinatal Death
• Safety Issues

• NCT number: NCT03053076
• Study type: Interventional
• Source: Guangdong Women and Children Hospital
• Contact: zhuxiao Ren, MD
• Phone: +8613538984634
• Email: renzhx1990@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: February 10, 2017
• Completion date: May 15, 2017