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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ZhuXiao Ren, MD; Phone Number: +86 +8613538984634; Email: renzhx1990@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 511442
      • Recruiting
      • Jie Yang
      • Contact: Jie Yang, PHD; Phone Number: 020 39151777; Email: jasjie_yang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangdong Women and Children Hospital
• Investigators: Principal Investigator: Jie Yang, PHD, Guangdong Women and Children Hospital

Publications and helpful links

General Publications

• 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.
• Ren Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang QI, Yang J. Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT03053076]. Front Pediatr. 2020 Apr 2;8:136. doi: 10.3389/fped.2020.00136. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Anticipated): May 15, 2017
• Study Completion (Anticipated): May 15, 2017

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: safety; neonates; effect; cord blood mononuclear cells
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Perinatal Death
• Other Study ID Numbers: GuangdongWCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No