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

Guangdong Women and Children Hospital

Status and phase: Unknown; Phase 1

Conditions: Neonatal Death; Effect of Drugs; Safety Issues

Treatments: Drug: 0.9% Sodium Chloride; Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03053076

GuangdongWCH

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 28 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Twenty-eight weeks to thirty-seven weeks

Exclusion criteria

• Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Placebo1

Placebo Comparator group

Description:

0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h，

Treatment:

Drug: 0.9% Sodium Chloride

CBMNC

Experimental group

Description:

Autologous Umbilical Cord Blood Mononuclear Cells Therapy 48 hours after birth ,dose is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，

Treatment:

Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy