Umbilical Cord Blood Cells for Diaphragmatic Hernia

Recruiting in Palo Alto (17 mi)

Overseen byMatthew T. Harting, MD, MS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Matthew T. Harting, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for infants with high-risk congenital diaphragmatic hernia (CDH). Eligible babies must have specific prenatal ultrasound or MRI findings, or postnatal signs of significant oxygen deprivation. Infants with severe brain abnormalities, involvement in other intervention studies, inability to follow-up, prematurity under 30 weeks gestation, certain genetic conditions or major heart defects cannot participate.

Inclusion Criteria

Fetal criteria: ultrasound (US)-obtained observed to expected lung to head ratio (o/e LHR) less than or equal to 35% or fetal magnetic resonance imaging (fMRI)-obtained observed to expected total fetal lung volume (o/e TFLV) less than or equal to 35%

Postnatal criteria: Cord blood gas (CBG) with potential hydrogen (pH) <7.0, Arterial blood gas (ABG) with pH <7.2 on 2 gasses within the first 24 hours, Preductal oxygen saturation (O2 sat) <90% x 2 total hours within the first 24 hours, or Oxygenation Index (OI) >20 x 2 total hours within the first 24 hours

My baby was diagnosed with CDH between 20 and 36 weeks of pregnancy.

Exclusion Criteria

Participation in an alternative prenatal intervention study: Fetoscopic Endotracheal Occlusion (FETO)

I have a significant genetic condition like Trisomy 21, but not a mild genetic issue.

I have a serious heart condition from a specific list.

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Treatment Details

Interventions

Autologous umbilical cord blood (Stem Cell Therapy)

Trial OverviewThe study tests if autologous umbilical cord blood cells can reduce brain damage from low oxygen levels in infants with CDH. It's a novel approach focusing on newborns who meet strict criteria based on lung measurements and early signs of inadequate oxygenation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Autologous umbilical cord bloodExperimental Treatment1 Intervention