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Stem Cell Therapy
Umbilical Cord Blood Cells for Diaphragmatic Hernia
Phase 1
Recruiting
Led By Matthew T. Harting, MD, MS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CDH between 20 and 36 weeks estimated gestational age (EGA)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of birth, prior to operative repair (occurs between day 2 & 14 of life), prior to discharge (usually 2-6 months), and after discharge (2wks-6 months following discharge)
Awards & highlights
Study Summary
This trial will investigate whether autologous umbilical cord blood can help improve neurologic outcomes for infants with high-risk congenital diaphragmatic hernia.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since the treatment uses the infant’s own umbilical cord blood cells, risks may be minimal compared to donor cell treatments. However, potential side effects are not detailed here and would likely relate to the procedure of administering these cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was diagnosed with CDH between 20 and 36 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours of birth, prior to operative repair (occurs between day 2 & 14 of life), prior to discharge (usually 2-6 months), and after discharge (2wks-6 months following discharge)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of birth, prior to operative repair (occurs between day 2 & 14 of life), prior to discharge (usually 2-6 months), and after discharge (2wks-6 months following discharge)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurologic/neurodevelopmental status as assessed by Bayley Scales of Infant and Toddler Development-III (BSID-III)
Neurologic/neurodevelopmental status as assessed by intracranial abnormalities upon magnetic resonance imaging (MRI)
Neurologic/neurodevelopmental status as assessed by receipt of neurologic pharmacologic medications
+27 moreSecondary outcome measures
Duration of extracorporeal membrane oxygenation (ECMO) support
Duration of ventilatory support
Length of stay in hospital
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Autologous umbilical cord bloodExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous umbilical cord blood
2019
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,957 Total Patients Enrolled
Texas Medical Center Regenerative Medicine ConsortiumUNKNOWN
Matthew T. Harting, MD, MSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I do not have severe brain injuries or abnormalities.I was born before reaching 30 weeks of pregnancy.I am unable to commit to follow-up visits.My baby was diagnosed with CDH between 20 and 36 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous umbilical cord blood
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has the participant count increased for this clinical trial?
"Affirmative. According to the records available on clinicaltrials.gov, this research is currently in its recruitment phase; it was initiated on August 1st 2018 and recently updated March 31st 2022. This study requires 20 participants from a single medical centre."
Answered by AI
Does the protocol admit applicants over 45 years of age?
"The boundary conditions for this trial dictate that the lowest possible age of participation is 10 Minutes, while the upper limit sits at 7 Days."
Answered by AI
Has the FDA given its stamp of approval to Autologous umbilical cord blood?
"Autologous umbilical cord blood is still in its early stages of clinical trials, so it was awarded a score of 1 on the safety scale. Data supporting both efficacy and safety are scarce at this time."
Answered by AI
Are there vacancies available for individuals to participate in this trial?
"As per clinicaltrials.gov, this medical trial is in the process of identifying volunteers for participation and has been since August 1st 2018. The most recent update was posted on March 31st 2022."
Answered by AI
Might I be eligible to participate in this experiment?
"Eligibility for this trial mandates that patients have morgagni hernias and should be between 10 minutes to 7 days old. Approximately 20 individuals are being recruited in total."
Answered by AI
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