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Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal, Cerebral Ischemia of Newborn

Status
Unknown status
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
autologous umbilical cord blood (UCB)
standard care
Sponsored by
Mononuclear Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring umbilical cord blood

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • evidence of asphyxiation, defined by 5-minute Apgar score ≤ 5;
  • evidence of HIE, defined by UCB pH <7.15 or base excess ≤ 10mM;
  • subjects with HIE confirmed by clinical features and initial investigations;
  • subjects with evidence of anemia, defined by hematocrit < 40% or hemoglobin ≤ 13g/dL within the first 96 hours of life;
  • obtain the informed consent from parents

Exclusion Criteria:

  • congestive cardiac failure;
  • microcephaly, anencephaly, encephalocele, or other abnormality
  • conjoint twins;
  • chromosomal disorders
  • fetal alcohol syndrome
  • spinal bifida or other neural tube defects
  • subjects have other neurological deficit conditions
  • polycythemia
  • congenital hematological malignancy
  • investigator decision

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study Group

Control Group

Arm Description

autologous UCB transfusion

standard care

Outcomes

Primary Outcome Measures

HIE: Mortality
Mortality Rate of the HIE Subjects
Anemia: Change from Baseline Hematocrit
Change from Baseline Hematocrit of the Anemia Subjects

Secondary Outcome Measures

HIE: HINE
Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects
HIE: HNNE
Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects
HIE: GMDS
Griffiths Mental Development Scale (GMDS) of the HIE Subjects
HIE: CBCL
Child Behavior Checklist for Attention Deficit of the HIE Subjects
HIE: Q-CHAT
Quantitative Checklist for Autism in Toddlers of the HIE Subjects
Anemia: hemoglobin
Change from Baseline hemoglobin of the Anemia Subjects
Anemia: Oxygenation level
Change from Baseline SpO2 of the Anemia Subjects
Anemia: Oxidative Stress Level
Change of Baseline Isoprostane of the Anemia Subjects
Anemia: Requirements of Packed Cell Transfusion
Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects

Full Information

First Posted
November 15, 2017
Last Updated
June 5, 2018
Sponsor
Mononuclear Therapeutics Ltd.
Collaborators
Chinese University of Hong Kong, China Spinal Cord Injury Network
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1. Study Identification

Unique Protocol Identification Number
NCT03352310
Brief Title
Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
Official Title
Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mononuclear Therapeutics Ltd.
Collaborators
Chinese University of Hong Kong, China Spinal Cord Injury Network

4. Oversight

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

5. Study Description

Brief Summary
The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group. Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal, Cerebral Ischemia of Newborn, Anemia, Neonatal
Keywords
umbilical cord blood

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Study Group - autologous umbilcial cord blood transfusion Control Group - standard care
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
autologous UCB transfusion
Arm Title
Control Group
Arm Type
Other
Arm Description
standard care
Intervention Type
Biological
Intervention Name(s)
autologous umbilical cord blood (UCB)
Intervention Description
autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth
Intervention Type
Procedure
Intervention Name(s)
standard care
Intervention Description
standard care procedure to the newborn infants presence of HIE and/or anemia
Primary Outcome Measure Information:
Title
HIE: Mortality
Description
Mortality Rate of the HIE Subjects
Time Frame
6 months
Title
Anemia: Change from Baseline Hematocrit
Description
Change from Baseline Hematocrit of the Anemia Subjects
Time Frame
48 hours, 1 week, 3 months, 6 months
Secondary Outcome Measure Information:
Title
HIE: HINE
Description
Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects
Time Frame
6 months, 1 year and 2 years
Title
HIE: HNNE
Description
Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects
Time Frame
-1 day, 3 months (before discharge)
Title
HIE: GMDS
Description
Griffiths Mental Development Scale (GMDS) of the HIE Subjects
Time Frame
6 months, 1 year and 2 years
Title
HIE: CBCL
Description
Child Behavior Checklist for Attention Deficit of the HIE Subjects
Time Frame
2 years
Title
HIE: Q-CHAT
Description
Quantitative Checklist for Autism in Toddlers of the HIE Subjects
Time Frame
2 years
Title
Anemia: hemoglobin
Description
Change from Baseline hemoglobin of the Anemia Subjects
Time Frame
48 hours, 1 week, 3 months and 6 months
Title
Anemia: Oxygenation level
Description
Change from Baseline SpO2 of the Anemia Subjects
Time Frame
48 hours, 1 week
Title
Anemia: Oxidative Stress Level
Description
Change of Baseline Isoprostane of the Anemia Subjects
Time Frame
48 hours, 1 week, 3 months, and 6 months
Title
Anemia: Requirements of Packed Cell Transfusion
Description
Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Incidence of Adverse Event
Description
Safety outcomes are Incidence of Adverse Events
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: evidence of asphyxiation, defined by 5-minute Apgar score ≤ 5; evidence of HIE, defined by UCB pH <7.15 or base excess ≤ 10mM; subjects with HIE confirmed by clinical features and initial investigations; subjects with evidence of anemia, defined by hematocrit < 40% or hemoglobin ≤ 13g/dL within the first 96 hours of life; obtain the informed consent from parents Exclusion Criteria: congestive cardiac failure; microcephaly, anencephaly, encephalocele, or other abnormality conjoint twins; chromosomal disorders fetal alcohol syndrome spinal bifida or other neural tube defects subjects have other neurological deficit conditions polycythemia congenital hematological malignancy investigator decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Lam, MD
Phone
+852 35052851
Email
hshslam@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Wang, MD
Phone
+852 35052810
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Lam, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Lam, M.D.
Phone
+852 35052851
First Name & Middle Initial & Last Name & Degree
Simon Lam, MD
First Name & Middle Initial & Last Name & Degree
Ronald Wang, MD
First Name & Middle Initial & Last Name & Degree
Chi Kong Li, MD
First Name & Middle Initial & Last Name & Degree
Eva Fung, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

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