ClinicalTrials.gov record
Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT03635450

Public ClinicalTrials.gov record NCT03635450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 1:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Study of hCT-MSC, an Umbilical Cord-Derived Mesenchymal Stromal Cell Product, in Newborn Infants With Moderate or Severe Hypoxic- Ischemic Neonatal Encephalopathy.

Study identification

NCT ID
NCT03635450
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Joanne Kurtzberg, MD
Other
Enrollment
6 participants

Conditions and interventions

Interventions

  • Infusion of hCT-MSC Biological

Biological

Eligibility (public fields only)

Age range
0 Hours to 48 Hours
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 26, 2018
Primary completion
Jul 27, 2019
Completion
Dec 27, 2020
Last update posted
Apr 11, 2024

2018 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Duke University Durham North Carolina 27705

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03635450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 11, 2024 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03635450 live on ClinicalTrials.gov.

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