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Prevention of Preterm Infection by Autologous Umbilical Cord Blood Mononuclear Cells Therapy

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ClinicalTrials.gov Identifier: NCT02999373
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

Brief Summary:
About 37% of neonatal mortality are caused by infection worldwidely . Excessive application of broad-spectrum antibiotics increased drug-resistance, however does not decrease morbility and mortality of neonates. Based on the investigator' early in vitro experiments which found cord blood mononuclear cells can inhibit bacterial growth and reduce of drug-resistance, along with other studies conducted recently from other groups who have reported the successful use of umbilical cord blood mononuclear cells in animal sepsis.The investigator would like to investigate the effects of umbilical cord blood mononuclear cells on prevention effect of preterm infection.

Condition or disease Intervention/treatment Phase
Infection, Bacteroides Neonates Premature 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 80 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg,6 hours or 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.

  1. Eligibility Criteria:Preterm (gestational age more than 28weeks and less than 37weeks )
  2. Exclusion criteria:Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
  3. 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)

  4. Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously
  5. 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.

    When the clinical symptoms suggests infection, blood cultures were performed before administration of antibiotics, and antibiotics were adjusted according to the susceptibility of the isolated bacteria.

  6. The following are monitored at 3、7、14、21days after birth :

    panels of cytokine and biomarkers(CRP、TNF-α、IL-6、IL-10、MCP-1) are examined by Elisa, circulating stem cell levels, immune cells subgroup ,platelet activation related markers CD62P、CD63 , number of megakaryocyte are evaluated by flow cytometry, infectious rate, mortality, incidence of multiple drug-resistant bacteria ,clinical complications: sepsis, bronchopulmonary dysplasia(BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), anaemia before hospital discharge

  7. Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth .

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Preterm Infection by Autologous Umbilical Cord Blood Mononuclear Cells(CBMNC) Therapy
Estimated Study Start Date : April 7, 2017
Estimated Primary Completion Date : July 15, 2018
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBMNC1
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 6 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 prevention of infection

Experimental: CBMNC2
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 prevention of infection

Placebo Comparator: Placebo1
0.9% sodium chloride infusion 6 hours after birth ,the infusion speed is 4ml/kg/h, 8-12h,
Drug: 0.9% Sodium Chloride
0.9% Sodium Chloride in control group

Placebo Comparator: Placebo2
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




Primary Outcome Measures :
  1. number of patients infected of bacteria measured by blood culture [ Time Frame: up tp 21dyas after birth ]
    infectious 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 1month, 3months, 6months,and 1y: neurodevelopment assessed by Bayley Score

  2. number of patients died before discharge from hospital [ Time Frame: up to 28days after birth ]
    mortality before discharge from hospital



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Ages Eligible for Study:   28 Weeks to 36 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): NCT02999373


Contacts
Contact: Zhuxiao Ren, MD +8613538984634 renzhx1990@163.com

Locations
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
Principal Investigator: Jie Yang, PHD Guangdong Women and Children Hospital

Publications:
Leung, Kam Tong; Lam, Hugh Simon; Chan, Kathy Yuen Yee, Decreased Frequency of Circulating CD34+Hematopoietic Stem/Progenitor Cells in Preterm Infants with Late-Onset Systemic Bacterial Infection,Blood,2014.124.21

Responsible Party: yangjie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT02999373     History of Changes
Other Study ID Numbers: Guangdong M And C
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
prevention, infection, preterm, cord blood mononuclear cells

Additional relevant MeSH terms:
Infection
Communicable Diseases
Perinatal Death
Premature Birth
Bacteroides Infections
Pregnancy Complications
Death
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Bacteroidaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections