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

Study Overview
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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

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. 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.

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

Conditions
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Safety Issues, Effect of Drugs, Neonatal Death

Intervention / Treatment
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* Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
* Drug: 0.9% Sodium Chloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo1<br>0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h， | Drug: 0.9% Sodium Chloride<br>* 0.9% Sodium Chloride in control group<br>|
| Experimental: CBMNC<br>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， | Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy<br>* Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for safety and effect evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who died | mortality rate | up tp 21 days after birth | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cord blood mononuclear cells, safety, effect, neonates