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

NCT03635450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-12

No results posted yet for this study

Summary

To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.

Conditions

  • Moderate to Severe Hypoxic-ischemic Encephalopathy

Interventions

BIOLOGICAL

Infusion of hCT-MSC

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.

Sponsors & Collaborators

  • Duke Clinical and Translational Science Institute (CTSI), part of the NIH Clinical and Translational Science Awards (CTSA)

    collaborator UNKNOWN

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Michael Cotten, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2019-07-28
Completion
2020-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635450 on ClinicalTrials.gov