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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053076
• Other study ID #: GuangdongWCH
• Status: Recruiting
• Phase: Phase 1
• First received: February 10, 2017
• Last updated: April 7, 2017
• Start date: February 10, 2017
• Est. completion date: May 15, 2017

Study information

• Verified date: April 2017
• Source: Guangdong Women and Children Hospital
• Contact: zhuxiao Ren, MD
• Phone: +8613538984634
• Email: renzhx1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Effect of Drugs
• Neonatal Death
• Perinatal Death
• Safety Issues

Intervention

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

Drug:
• 0.9% Sodium Chloride
0.9% Sodium Chloride in control group

Locations

Country	Name	City	State
China	Jie Yang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who died	mortality rate	up tp 21 days after birth
Secondary	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