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

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ClinicalTrials.gov Identifier: NCT03053076
Recruitment Status : Unknown
Verified April 2017 by yangjie, Guangdong Women and Children Hospital.
Recruitment status was:  Recruiting
First Posted : February 14, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

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.

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 10, 2017
Estimated Primary Completion Date : May 15, 2017
Estimated Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. number of patients who died [ Time Frame: up tp 21 days after birth ]
    mortality rate


Secondary Outcome Measures :
  1. number of patients with neurodevelopmental disorder assessed by Bayley Score [ Time Frame: 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



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Ages Eligible for Study:   28 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053076


Contacts
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Contact: zhuxiao Ren, MD +8613538984634 ext +86 renzhx1990@163.com

Locations
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China, Guangdong
Jie Yang Recruiting
Guangzhou, Guangdong, China, 511442
Contact: Jie Yang, PHD    39151777 ext 020    jasjie_yang@163.com   
Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
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Principal Investigator: Jie Yang, Phd Guangdong Women and Children Hospital

Publications of Results:
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Responsible Party: yangjie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT03053076     History of Changes
Other Study ID Numbers: GuangdongWCH
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yangjie, Guangdong Women and Children Hospital:
cord blood mononuclear cells
safety
effect
neonates

Additional relevant MeSH terms:
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Perinatal Death
Pregnancy Complications
Death
Pathologic Processes