<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760900</url>
  </required_header>
  <id_info>
    <org_study_id>Guang dong WCH</org_study_id>
    <nct_id>NCT03760900</nct_id>
  </id_info>
  <brief_title>Safety of Autologous Cord Blood Cells for Preterm Infants.</brief_title>
  <official_title>Safety of Autologous Cord Blood Cells for Preterm Infants.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Women and Children Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Women and Children Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved&#xD;
      umbilical cord blood (UCB) cell infusion to preterm infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm birth complications are one of the leading causes of death among children under 5&#xD;
      years of age. Despite advances in medical care, many survivors face a lifetime of disability,&#xD;
      including mental and physical retardation, and chronic lung disease. More recently, both&#xD;
      allogenic and autogenic cord blood cells have been applied in the treatment of neonatal&#xD;
      conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia&#xD;
      (BPD).&#xD;
&#xD;
      Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced&#xD;
      non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.&#xD;
&#xD;
      Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the&#xD;
      safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg)&#xD;
      infusion for preterm infants &lt;37 weeks gestational age. UCB cell characteristics, pre- and&#xD;
      post- infusion vital signs, laboratory investigations were recorded. Clinical data including&#xD;
      mortality rates and preterm complications were recorded.&#xD;
&#xD;
      Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in&#xD;
      number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM),&#xD;
      (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No&#xD;
      adverse effects were noticed during treatment. All fifteen patients who received UCB infusion&#xD;
      survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding&#xD;
      preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity&#xD;
      (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and&#xD;
      5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia&#xD;
      respectively.&#xD;
&#xD;
      Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm&#xD;
      infants is feasible and safe. Adequately powered randomized controlled studies are needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Actual">June 5, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 2010</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants</measure>
    <time_frame>during infusion</time_frame>
    <description>vital signs&#xD;
blood gas analysis&#xD;
blood routine&#xD;
liver and kidney function before and after infusion will be compared</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants</measure>
    <time_frame>6 hours after infusion</time_frame>
    <description>vital signs&#xD;
blood gas analysis&#xD;
blood routine&#xD;
liver and kidney function before and after infusion will be compared</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants</measure>
    <time_frame>2years</time_frame>
    <description>1. The growth and development curve will be drawn and compared</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Safety Issues</condition>
  <condition>Effect of Drugs</condition>
  <condition>Neonatal Death</condition>
  <arm_group>
    <arm_group_label>infusion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous Umbilical Cord Blood Stem Cells Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Autologous Umbilical Cord Blood Stem Cells Therapy</intervention_name>
    <description>Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth</description>
    <arm_group_label>infusion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and&#xD;
        Children's Hospital were eligible if they were: 1. Preterm: &lt;37 weeks gestation 2. Without&#xD;
        congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the&#xD;
        mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis,&#xD;
        HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes&#xD;
        simplex virus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>37 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jie Yang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Women and Children Hospital and Healthy Institutes</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Women and Children Hospital</investigator_affiliation>
    <investigator_full_name>yangjie</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Autologous Umbilical Cord Blood Stem Cells</keyword>
  <keyword>Safety</keyword>
  <keyword>Effect</keyword>
  <keyword>neonates</keyword>
  <keyword>Mechanism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Perinatal Death</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 18, 2020</submitted>
    <returned>July 10, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760900
org study id: Guang dong WCH
nct id: NCT03760900
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved
      umbilical cord blood (UCB) cell infusion to preterm infants.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
time frame: during infusion
description: vital signs
blood gas analysis
blood routine
liver and kidney function before and after infusion will be compared
measure: Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
time frame: 6 hours after infusion
description: vital signs
blood gas analysis
blood routine
liver and kidney function before and after infusion will be compared
measure: Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
time frame: 2years
description: 1. The growth and development curve will be drawn and compared
arm group label: infusion group
arm group type: Experimental
description: Autologous Umbilical Cord Blood Stem Cells Therapy
intervention type: Combination Product
intervention name: Autologous Umbilical Cord Blood Stem Cells Therapy
description: Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth
arm group label: infusion group
criteria: 
gender: All
minimum age: N/A
maximum age: 37 Weeks
healthy volunteers: No
last name: jie Yang, PHD
role: Principal Investigator
affiliation: Guangdong Women and Children Hospital and Healthy Institutes
responsible party type: Principal Investigator
investigator affiliation: Guangdong Women and Children Hospital
investigator full name: yangjie
investigator title: Professor
mesh term: Perinatal Death
submitted: June 18, 2020
returned: July 10, 2020