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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2017-05-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Safety Issues Effect of Drugs Neonatal Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo1

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

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type DRUG

0.9% Sodium Chloride in control group

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，

Group Type EXPERIMENTAL

Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Intervention Type OTHER

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

Interventions

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Autologous Umbilical Cord Blood Mononuclear Cells Therapy

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

Intervention Type OTHER

0.9% Sodium Chloride

0.9% Sodium Chloride in control group

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No