CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Infusion of autologous cord blood +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02612155
NCT02612155Phase 2Completed
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A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)

Michael Cotten·interventional·Posted Nov 23, 2015·Updated May 16, 2024

In Brief

A Phase 2 clinical trial evaluating Infusion of autologous cord blood and Placebo for Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate or Severe Hypoxic-ischemic Encephalopathy in Newborns
CountriesUnited States
CollaboratorsThe Robertson Foundation

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 23, 2015
Enrollment StartMar 30, 2017
Primary CompletionAug 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.6 years ago

Interventions

Infusion of autologous cord bloodbiological

Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.

Placebobiological

Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.