Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
Overview
- Phase
- Phase 1
- Intervention
- 0.9% Sodium Chloride
- Conditions
- Safety Issues
- Sponsor
- Guangdong Women and Children Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- number of patients who died
- Last Updated
- 9 years ago
Overview
Brief Summary
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
Detailed 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.
Investigators
yangjie
Professor
Guangdong Women and Children Hospital
Eligibility 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
Arms & Interventions
Placebo1
0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h，
Intervention: 0.9% Sodium Chloride
CBMNC
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，
Intervention: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Outcomes
Primary Outcomes
number of patients who died
Time Frame: up tp 21 days after birth
mortality rate
Secondary Outcomes
- number of patients with neurodevelopmental disorder assessed by Bayley Score(up to 1 month, 3 months, 6 months and 1 year)