Trial | NCT03053076  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
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.

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

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.
Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth.
Study Started
Feb 10
2017
Primary Completion
May 15
2017
Anticipated
Study Completion
May 15
2017
Anticipated
Last Update
Apr 10
2017

Other Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for safety and effect evaluation

Drug 0.9% Sodium Chloride

0.9% Sodium Chloride in control group

Placebo1 Placebo Comparator

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

CBMNC Experimental

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，

Criteria 

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
No Results Posted