Clinical trial NCT03053076: Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
Official title: Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Safety Issues
Effect of Drugs
Neonatal Death
Keywords: cord blood mononuclear cells
safety
effect
neonates
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: number of patients who died
timeFrame: up tp 21 days after birth
Secondary outcomes:
measure: number of patients with neurodevelopmental disorder assessed by Bayley Score
timeFrame: up to 1 month, 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
affiliation: Guangdong Women and Children Hospital
name: Jie Yang, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14.
citation: Ren Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang QI, Yang J. Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT03053076]. Front Pediatr. 2020 Apr 2;8:136. doi: 10.3389/fped.2020.00136. eCollection 2020.