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

Sponsor

Guangdong Women and Children Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03053076

Collaborator

(none)

200

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

64.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Safety Issues Effect of Drugs Neonatal Death	Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy Drug: 0.9% Sodium Chloride	Phase 1

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 10, 2017

Anticipated Primary Completion Date :

May 15, 2017

Anticipated Study Completion Date :

May 15, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo1

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

Drug: 0.9% Sodium Chloride

0.9% Sodium Chloride in control group

Experimental: 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，

Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

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

Outcome Measures

Primary Outcome Measures

number of patients who died [up tp 21 days after birth]
mortality rate

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jie Yang	Guangzhou	Guangdong	China	511442

Sponsors and Collaborators

Guangdong Women and Children Hospital

Investigators

Principal Investigator: Jie Yang, Phd, Guangdong Women and Children Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yangjie, Professor, Guangdong Women and Children Hospital

ClinicalTrials.gov Identifier:

NCT03053076

Other Study ID Numbers:

GuangdongWCH

First Posted:

Feb 14, 2017

Last Update Posted:

Apr 10, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by yangjie, Professor, Guangdong Women and Children Hospital

cord blood mononuclear cells

safety

effect

neonates

Additional relevant MeSH terms:

Perinatal Death

Study Results

No Results Posted as of Apr 10, 2017