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Safety of Autologous Cord Blood Cells for Preterm Infants.

Primary Purpose

Safety Issues, Effect of Drugs, Neonatal Death

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Autologous Umbilical Cord Blood Stem Cells Therapy
Sponsored by
Guangdong Women and Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Safety Issues focused on measuring Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism

Eligibility Criteria

undefined - 37 Weeks (Child)All SexesDoes not accept healthy volunteers
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    infusion group

    Arm Description

    Autologous Umbilical Cord Blood Stem Cells Therapy

    Outcomes

    Primary Outcome Measures

    Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
    vital signs blood gas analysis blood routine liver and kidney function before and after infusion will be compared
    Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
    vital signs blood gas analysis blood routine liver and kidney function before and after infusion will be compared
    Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
    1. The growth and development curve will be drawn and compared

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2018
    Last Updated
    May 29, 2020
    Sponsor
    Guangdong Women and Children Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03760900
    Brief Title
    Safety of Autologous Cord Blood Cells for Preterm Infants.
    Official Title
    Safety of Autologous Cord Blood Cells for Preterm Infants.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2009 (Actual)
    Primary Completion Date
    January 1, 2010 (Actual)
    Study Completion Date
    June 5, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangdong Women and Children Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
    Detailed Description
    Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD). Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants. Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded. Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively. Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Safety Issues, Effect of Drugs, Neonatal Death
    Keywords
    Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    infusion group
    Arm Type
    Experimental
    Arm Description
    Autologous Umbilical Cord Blood Stem Cells Therapy
    Intervention Type
    Combination Product
    Intervention Name(s)
    Autologous Umbilical Cord Blood Stem Cells Therapy
    Intervention Description
    Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth
    Primary Outcome Measure Information:
    Title
    Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
    Description
    vital signs blood gas analysis blood routine liver and kidney function before and after infusion will be compared
    Time Frame
    during infusion
    Title
    Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
    Description
    vital signs blood gas analysis blood routine liver and kidney function before and after infusion will be compared
    Time Frame
    6 hours after infusion
    Title
    Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
    Description
    1. The growth and development curve will be drawn and compared
    Time Frame
    2years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    37 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    jie Yang, PHD
    Organizational Affiliation
    Guangdong Women and Children Hospital and Healthy Institutes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety of Autologous Cord Blood Cells for Preterm Infants.

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