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

Phase 1

• Conditions: Neonatal Death; Safety Issues; Effect of Drugs
• Interventions: Drug: 0.9% Sodium Chloride; Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

• Registration Number: NCT03053076
• Lead Sponsor: Guangdong Women and Children Hospital

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.

Study Timeline

• Study Start: 2017-02-10
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-14
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo1	0.9% Sodium Chloride	0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h，
CBMNC	Autologous Umbilical Cord Blood Mononuclear Cells Therapy	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，

Primary Outcome Measures

Name	Time	Method
number of patients who died	up tp 21 days after birth	mortality rate

Secondary Outcome Measures

Name	Time	Method
number of patients with neurodevelopmental disorder assessed by Bayley Score	up to 1 month, 3 months, 6 months and 1 year	Long term follow up: in 1 month, 3 months, 6 months, and 1 year: neuro-development

Trial Locations

Locations (1)

Jie Yang; 🇨🇳 Guangzhou, Guangdong, China