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Tissue Graft
Fetoscopic Umbilical Cord Repair for Spina Bifida
N/A
Recruiting
Led By Ramesha Papanna, MD, MPH
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
Maternal: Age 18 years and older
Fetal: Normal karyotype, or normal CMA, or a CMA with variants of unknown significance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 ± 2 months, 30-36 months and 60-66 months post birth
Awards & highlights
Study Summary
This trial will use NEOX Cord 1K®, which are cryopreserved human umbilical cord allografts, to cover spina bifida defects in order to decrease the rates of postnatal morbidities.
Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy, carrying fetuses with spina bifida but no other major unrelated anomalies or kyphosis. The fetus must have a normal karyotype and the defect between T1 to S1 vertebral levels. Women must be within a specific gestational age range, have no significant health risks or previous preterm deliveries, and BMI under 40 kg/m2.Check my eligibility
What is being tested?
The trial tests the use of NEOX Cord 1K®, cryopreserved human umbilical cord allografts, applied via fetoscopy as a cover for spina bifida defects in fetuses. It aims to create a watertight seal on the spinal cord to reduce postnatal complications and may also serve as skin cover for larger defects.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical surgical risks such as infection at the surgery site, reaction to anesthesia, premature labor or delivery due to surgical intervention, and possible harm to the fetus during procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My unborn baby's genetic tests are normal or show unknown changes.
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My unborn baby has been diagnosed with Chiari II malformation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 ± 2 months; 30-36 months and 60-66 months post birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 ± 2 months; 30-36 months and 60-66 months post birth
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with successful fetoscopic repair of the defect using NEOX Cord 1K®
Secondary outcome measures
Number of patients with intact repair of the defect as defined as no cerebrospinal fluid leakage and no dehiscence at the repair site.
Number of patients with intact repair of the defect, defined as no cerebrospinal fluid leakage and no dehiscence at the repair site.
Other outcome measures
Achievement as measured by the Woodcock-Johnson IV Test of Achievement test
Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales III
Assess brain stem function, as measured by the child's swallowing profile
+16 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NEOX Cord 1K applied fetoscopicallyExperimental Treatment1 Intervention
Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,947 Total Patients Enrolled
Ramesha Papanna, MD, MPH5.01 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have any factors that could increase the risk of having a baby born too early.I am HIV or Hepatitis-B positive.The placenta is in the wrong place or there is bleeding behind the placenta during pregnancy.If you are pregnant, your cervix is shorter than 20 millimeters.If you are a mother, you have a history of specific conditions related to pregnancy and blood compatibility.The mother has been diagnosed with Hepatitis C.I am 18 years old or older.The mother is pregnant with more than one baby.The baby does not have a curved spine.My BMI is over 40, classifying me as obese.The baby has a condition where the fluid spaces in the brain are larger than normal, and there are no movements in the hip and knee joints.You have given birth to a baby before 37 weeks without any medical intervention.The baby has a major birth defect that is not related to spina bifida.The unborn baby does not have a major, life-threatening abnormality not related to spina bifida.I have health issues that make surgery or anesthesia risky.If you are allergic to or have had a bad reaction to Amphotericin B, you cannot participate.The baby in the womb has a back curve of 30 degrees or more.Pregnant women with a body mass index less than 40 kg/m2.Pregnant women between 19 to 25 5/7 weeks along can participate, and surgery can be done between 22 to 25 6/7 weeks of pregnancy.If you are pregnant and have Zika virus.The mother has high blood pressure.My unborn baby's genetic tests are normal or show unknown changes.You have poorly controlled insulin-dependent diabetes before getting pregnant.Unborn babies with a spinal defect between the first and last vertebrae will not be included.Expectant mothers with poorly managed insulin-dependent diabetes.My unborn baby has been diagnosed with Chiari II malformation.I have a diagnosed uterine condition like fibroids or a structural abnormality.
Research Study Groups:
This trial has the following groups:- Group 1: NEOX Cord 1K applied fetoscopically
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.
Are there any opportunities to join this clinical investigation?
"The data available on clinicaltrials.gov implies that this medical study is currently recruiting participants. The trial was initially posted to the database on August 28th 2020 and underwent its most recent edit on June 14th 2022."
Answered by AI
How many participants are receiving treatment in this clinical research study?
"Affirmative. According to the information present on clinicaltrials.gov, this investigation is recruiting participants with vigor; it was posted initially on August 28th 2020 and had its most recent update on June 14th 2022. The research necessitates 50 people from a single location for completion of the trial."
Answered by AI
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