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Outcome Measures

Primary Outcomes (2)

Incidence of infusion reactions
for this study, infusion reactions are defined as anaphylactic or anaphylactoid reactions with clinical signs inclusive of skin rashes, bronchospasm, angioedema, myocardial infarcts, arrhythmias, and acute lung injury.
24 hours after each infusion
Incidence of Infections post-infusion
for this study, infections recorded as safety endpoints will be defined as bacterial, viral or fungal infections identified by culture or molecular methodologies within two weeks after administration of hCT-MSC.
Up to 2 Weeks

Secondary Outcomes (2)

Survival
Up to 6 months
Neurodevelopmental Assessments
Up to 16 postnatal months

Study Arms (2)

First cohort of 3 subjects enrolled

EXPERIMENTAL

The first cohort of three patients will receive a single dose in the first 48 postnatal hours.

Biological: Infusion of hCT-MSC

Second cohort of 3 subjects enrolled

EXPERIMENTAL

If there are no safety concerns after the first cohort of 3 subjects are infused then the second cohort of three patients will receive two doses, with the first dose given in the first 48 postnatal hours and the second dose given approximately two months after the first dose.

Biological: Infusion of hCT-MSC

Interventions

Infusion of hCT-MSCBiological

Infants who meet enrollment criteria for moderate to severe hypoxic ischemic encephalopathy will receive 1 infusion of hCT-MSC within the first 48 postnatal hours. hCT-MSCs are a product of allogeneic cells manufactured from digested umbilical cord tissue that is expanded in culture, cryopreserved and banked. hCT-MSCs are manufactured from umbilical cord tissue donated to the Carolinas Cord Blood Bank, an FDA-licensed, FACT-accredited, public cord blood bank at Duke University Medical Center, after written informed consent from the baby's mother. Cord tissue is harvested from the placentas of male babies delivered by elective C-section after a normal, full- term pregnancy.

First cohort of 3 subjects enrolledSecond cohort of 3 subjects enrolled

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MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type

interventional

Phase

phase 1

Allocation

NON RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: The first cohort of three patients will receive a single dose in the first 48 postnatal hours. If there are no safety concerns, the second cohort of three patients will receive two doses, with the first dose given in the first 48 postnatal hours and the second dose given approximately two months after the first dose.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Professor Department of Pediatrics

Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

First cohort of 3 subjects enrolled

Second cohort of 3 subjects enrolled

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

First cohort of 3 subjects enrolled

Second cohort of 3 subjects enrolled

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations