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Fetoscopic Umbilical Cord Repair for Spina Bifida
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: NEOX Cord 1K applied fetoscopically
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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