Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2024-07-01

Brief Summary

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The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).

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Detailed Description

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Conditions

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Congenital Diaphragmatic Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous umbilical cord blood

Group Type EXPERIMENTAL

Autologous umbilical cord blood

Intervention Type BIOLOGICAL

6×10\^6 mononuclear cells isolated from the patient's own umbilical cord blood per dose. 4 total doses administered intravenously over 7 days.

Interventions

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Autologous umbilical cord blood

6×10\^6 mononuclear cells isolated from the patient's own umbilical cord blood per dose. 4 total doses administered intravenously over 7 days.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of CDH between 20 and 36 weeks estimated gestational age (EGA)
* Only one of the following fetal criteria and one of the following postnatal criteria must be met for enrollment. Fetal criteria: an ultrasound (US)-obtained observed to expected lung to head ratio (o/e LHR) less than or equal to 35% or 2) a fetal magnetic resonance imaging (fMRI)- obtained observed to expected total fetal lung volume (o/e TFLV) less than or equal to 35%. Postnatal criteria: 1) Cord blood gas (CBG) with potenital hydrogen (pH) \<7.0, 2) Arterial blood gas (ABG) with pH \<7.2 on 2 gasses within the first 24 hours, 3) Preductal oxygen saturation (O2 sat) \<90% x 2 total hours (not necessarily consecutive) within the first 24 hours, or 4) Oxygenation Index (OI) \>20 x 2 total hours (not necessarily consecutive) within the first 24 hours.

Exclusion Criteria

* Genetic/chromosomal abnormality: Trisomy 21, Trisomy 18, Trisomy 13 or other, significant genetic abnormality. Microdeletions or other mild genetic abnormalities are not considered exclusionary.
* Severe/major cardiac anomaly: coarctation of the aorta, combined atrial and ventricular septal defects, hypoplastic left heart syndrome, tetralogy of fallot, double outlet right ventricle, atrioventricular canal defects, or other hemodynamically significant defects.
* Moderate/severe neurologic / intracranial abnormality: Grade III or IV intraparenchymal hemorrhage, space occupying mass or lesion, or clinically significant traumatic lesion such as a subdural or epidural hemorrhage.
* Prematurity \<30 weeks estimated gestational age (EGA): Birth at 29 6/7 weeks or before
* Participation in an alternative prenatal intervention study: Fetoscopic Endotracheal Occlusion (FETO)
* Unwillingness / inability to return for follow-up evaluation and assessment

Minimum Eligible Age

10 Minutes

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No